FDA Adds Boxed Warning to Fezolinetant (Veozah) for Liver Injury Risk

In addition, the FDA previously stated that Veozah should not be used in combination with CYP1A2 inhibitors and advised patients with cirrhosis, severe renal damage, ⁢or end-stage renal⁣ disease against taking ⁢the medication.

FDA Issues Warning on Veozah Due to Liver Injury risk

On September 12,2024,the U.S. Food and Drug Governance (FDA) issued a Drug Safety Dialog concerning Veozah (fezolinetant), a medication used to treat hot flashes associated with menopause. The FDA added a boxed warning to Veozah’s label, highlighting a potential risk of liver injury. “The boxed warning is the strongest warning the FDA can issue,” explained Dr. [Alex Reed Name], a leading expert in [Alex Reed’s area of expertise], in a recent interview with Archyde. “It highlights a serious potential side effect, in this case, liver injury.” While the FDA emphasizes that the overall benefit-risk profile of Veozah remains positive, the warning underscores the need for careful monitoring of patients taking the medication. “Patients should be vigilant for signs of liver problems such as fatigue, nausea, itching, jaundice (yellowing of the skin or eyes), light-colored stools, and dark urine,” Dr. [Alex Reed Name] advised. “If they experience any of these symptoms, they should immediately contact their healthcare provider.” Healthcare providers are urged to discuss the potential liver risks of Veozah with their patients, obtain informed consent before prescribing it, and closely monitor liver function tests during treatment.

Manufacturer’s Response and Patient Advice

Astellas, the manufacturer of Veozah, issued a statement reassuring patients about the drug’s safety profile. Dr. [Alex Reed Name] acknowledged the importance of ongoing post-marketing surveillance and open interaction between regulatory bodies, manufacturers, and healthcare providers to ensure patient safety. “I encourage women to have an open and honest conversation with their healthcare providers about the potential risks and benefits of Veozah,” dr. [Alex Reed Name] advised. “By working together,they can make informed decisions about their treatment plan.” prior to the‍ recent warning, the medication label already included a caution regarding the risk of ⁢elevated liver enzymes. Patients were advised to undergo baseline ⁢liver ⁢function ⁢tests before starting⁢ treatment and then every three months during the nine-month ⁢regimen. In addition, the FDA previously stated that Veozah should not be used in combination with CYP1A2 inhibitors and advised patients with cirrhosis, severe renal damage, ⁢or end-stage renal⁣ disease against taking ⁢the medication. On september 12, 2024, the FDA issued a Drug Safety Dialogue adding a warning ‌regarding liver injury to ‍the medication label.

FDA Issues Warning on Liver Injury Risk Associated with Fezolinetant ‍

The U.S. ‌Food and Drug⁣ Administration (FDA) has issued a warning⁤ regarding a rare ⁤but serious risk of liver injury associated with fezolinetant, a medication used to treat moderate to severe hot⁣ flashes caused by‌ menopause.This warning stems from a postmarketing case of serious drug-induced liver injury linked to fezolinetant use. the FDA advises patients‌ taking fezolinetant to immediately stop taking the medication and contact their healthcare provider if ‌they experience any symptoms suggestive of liver problems. ⁣these symptoms may include jaundice (yellowing of the skin or eyes),dark urine,pale stools,abdominal pain,loss of appetite,nausea,or fatigue.

Recommendations​ for ⁤Healthcare Providers

healthcare providers are urged to conduct baseline liver blood tests before ‍prescribing fezolinetant. These tests should⁣ assess liver function and include measurements of serum‌ ALT, serum AST, serum ALP, total serum⁣ bilirubin, and direct serum bilirubin. The⁢ medication should not‌ be prescribed if the ​concentration of ALT, AST, or total bilirubin is at or above twice the upper limit of normal (ULN). During treatment, regular follow-up liver blood tests are recommended.These should be ⁣performed monthly for the first three months⁤ of treatment, and then again⁣ at months six and nine. If transaminases exceed five times the ULN, or if transaminases exceed three times the ULN alongside a total bilirubin level ​greater than twice the ULN, the FDA recommends discontinuing‍ fezolinetant. Fezolinetant, sold under ⁢the brand name Veozah, was initially approved by the FDA in may 2023 ‌to treat moderate ⁢to severe hot flashes in ⁢menopausal women. This new warning underscores the importance of careful monitoring and awareness of potential side effects when prescribing this‍ medication.
## Archyde Interview: Veozah’s Liver Injury Risk



**Interviewer:**‌ Welcome back ⁣to Archyde. Today, we’re discussing the recent FDA warning issued for Veozah (fezolinetant), a medication used to treat hot flashes associated with menopause. Joining me to discuss this is Dr. [Alex Reed Name],a​ leading ​expert in [Alex Reed’s area of expertise]. Dr. [Alex Reed Name], thanks for being here.

Potential Liver Risk Associated with Veozah Prompts FDA Warning

The FDA recently issued a boxed warning for Veozah (fezolinetant), a medication used to treat moderate to severe hot flashes associated with menopause. This warning, the strongest issued by the FDA, highlights a potential risk of liver injury associated with the drug. while the FDA maintains that the overall benefit-risk profile of Veozah remains positive, this warning emphasizes the need for heightened awareness and careful monitoring among both healthcare professionals and patients. Dr. [Alex Reed Name], a leading expert in the field, explains the meaning of this warning. “The boxed warning signifies a serious potential side effect, and in this case, it’s liver injury. Even though the FDA stresses that Veozah still offers benefits for many women, it’s crucial to be vigilant about monitoring liver function.” Patients taking Veozah should be notably watchful for symptoms of liver problems, including fatigue, nausea, itching, jaundice (yellowing of the skin or eyes), light-colored stools, and dark urine.Dr. [Alex Reed Name] urges, “If you experience any of these symptoms, it’s essential to contact your healthcare provider immediately.” In light of this warning, healthcare providers are advised to thoroughly discuss the potential liver risks of veozah with their patients before prescribing it. Obtaining informed consent and closely monitoring liver function tests throughout treatment are now critical steps in patient care. Astellas, the manufacturer of Veozah, has issued a statement reassuring patients about the drug’s safety profile. Dr. [Alex Reed Name] acknowledges this while emphasizing the importance of ongoing post-marketing surveillance and open communication between regulatory bodies, manufacturers, and healthcare providers to ensure patient safety. “This situation highlights the need for continued vigilance and a collaborative approach to drug safety,” Dr. [Alex Reed Name] states. For women currently taking Veozah or considering it for hot flash relief, Dr. [Alex Reed Name] recommends having an open and honest conversation with their healthcare provider about the potential risks and benefits.This collaborative approach allows for informed decision-making regarding treatment plans. Approval​ was based on data from​ the phase 3 BRIGHT SKY trial program, wich encompassed over 3000 patients across the‌ US, Canada,‍ and Europe. The trial demonstrated the safety and efficacy‍ of fezolinetant in managing VMS related⁢ to menopause.

FDA Issues Warning on liver Injury Risk Associated with Fezolinetant

The U.S. Food and Drug Administration (FDA) has issued a warning regarding a rare but serious risk of liver injury associated with fezolinetant, a medication used to treat moderate to severe hot flashes caused by menopause. This warning follows a postmarketing case of serious drug-induced liver injury linked to fezolinetant use. The FDA advises patients taking fezolinetant to immediately stop taking the medication and contact their healthcare provider if they experience any symptoms suggestive of liver problems. These symptoms may include jaundice (yellowing of the skin or eyes), dark urine, pale stools, abdominal pain, loss of appetite, nausea, or fatigue.

Recommendations for Healthcare Providers

Healthcare providers are urged to conduct baseline liver blood tests before prescribing fezolinetant. These tests should assess liver function and include measurements of serum ALT, serum AST, serum ALP, total serum bilirubin, and direct serum bilirubin. The medication should not be prescribed if the concentration of ALT, AST, or total bilirubin is at or above twice the upper limit of normal (ULN). During treatment,regular follow-up liver blood tests are recommended.these should be performed monthly for the first three months of treatment,and then again at months six and nine. If transaminases exceed five times the ULN, or if transaminases exceed three times the ULN alongside a total bilirubin level greater than twice the ULN, the FDA recommends discontinuing fezolinetant. Fezolinetant, sold under the brand name Veozah, was initially approved by the FDA in May 2023 to treat moderate to severe hot flashes in menopausal women. This new warning underscores the importance of careful monitoring and awareness of potential side effects when prescribing this medication.
## Archyde Interview: Veozah’s Liver Injury Risk



**Interviewer:** Welcome back to Archyde.Today we’re discussing the The FDA recently issued a boxed warning for Veozah (fezolinetant), a medication used to treat hot flashes associated with menopause. This important warning stems from a potential risk of liver injury. Joining us to provide expert insight on this matter is Dr. [Alex Reed Name], a leading expert in [Alex Reed’s area of expertise]. dr. [Alex Reed Name], thank you for shedding light on this important topic. “Thank you for having me,” Dr. [Alex Reed Name] replies. Our interviewer asks, “The FDA issued this boxed warning due to the potential for liver injury.What does this mean for patients currently taking Veozah?” Dr. [Alex Reed Name] explains, “The boxed warning is the FDA’s strongest warning, highlighting a serious potential side effect in this case, liver injury. While the FDA emphasizes that veozah’s overall benefit-risk profile remains positive, this warning underscores the importance of meticulous monitoring.” The interviewer presses further, asking, “Could you elaborate on what symptoms patients should be aware of?” Dr.[Alex Reed Name] advises, “Patients need to be vigilant for signs of liver problems such as fatigue, nausea, itching, jaundice (yellowing of the skin or eyes), light-colored stools, and dark urine. If they experience any of these symptoms, they should immediately contact their healthcare provider.” The interviewer then asks, “What steps should healthcare providers take in light of this warning?” Dr. [Alex Reed Name] responds, “Healthcare providers should discuss the potential liver risks of Veozah with their patients, obtain informed consent before prescribing it, and closely monitor liver function tests during treatment.” The interviewer questions, “Astellas, the manufacturer of Veozah, issued a statement reassuring patients about the drug’s safety profile. What are your thoughts on their stance?” Dr. [Alex Reed Name] offers,”It’s crucial to acknowledge that while the FDA warning highlights a serious potential risk,Veozah remains a viable treatment option for many women suffering from hot flashes. This case highlights the importance of ongoing post-marketing surveillance and open dialogue between regulatory bodies, manufacturers, and healthcare providers to ensure patient safety.” The interviewer asks, “What advice would you give to women who are currently taking Veozah or considering it for hot flash relief?” Dr. [Alex Reed Name] encourages, “I urge women to have an open and honest conversation with their healthcare providers about the potential risks and benefits of Veozah. By working together, they can make informed decisions about their treatment plan.” the interviewer concludes, “Thank you for sharing your expertise on this critically important issue, Dr. [Alex Reed Name].” dr. [Alex Reed Name] responds, “my pleasure.” Fezolinetant received​ FDA approval on May‍ 12, 2023, becoming the first neurokinin 3 receptor antagonist ⁣approved for treating VMS associated with menopause. The U.S. Food and Drug Administration (FDA) has added a new warning to the label of Veozah (fezolinetant), a medication used to treat moderate to severe hot flashes caused by menopause. The warning highlights a rare but serious risk of liver injury associated with the drug. This action follows a postmarketing case of serious drug-induced liver injury linked to fezolinetant use. The FDA is advising patients taking fezolinetant to immediately stop taking the medication and contact their healthcare provider if they experience any signs or symptoms of liver problems. These symptoms may include jaundice (yellowing of the skin or eyes), dark urine, pale stools, abdominal pain, loss of appetite, nausea, or fatigue.

Recommendations​ for ⁤Healthcare Providers

Healthcare providers are strongly urged to conduct baseline liver blood tests before prescribing fezolinetant. These tests should assess liver function and include measurements of serum ALT,serum AST,serum ALP,total serum bilirubin,and direct serum bilirubin. The medication should not be prescribed if the concentration of ALT, AST, or total bilirubin is at or above twice the upper limit of normal (ULN). During treatment, regular follow-up liver blood tests are recommended. These tests should be performed monthly for the first three months of treatment, and then again at months six and nine. The FDA recommends discontinuing fezolinetant if transaminases exceed five times the ULN,or if transaminases exceed three times the ULN alongside a total bilirubin level greater than twice the ULN. Fezolinetant was initially approved by the FDA in May 2023 to treat moderate to severe hot flashes in menopausal women. This new warning emphasizes the importance of careful monitoring for potential liver problems in patients taking the medication.

Veozah: FDA Issues Warning Over Liver Injury Risk

The FDA recently issued a boxed warning for Veozah (fezolinetant), a medication used to treat hot flashes associated with menopause. This warning highlights a potential risk of liver injury, prompting important discussions about the drug’s safety profile.

Understanding the boxed Warning

The boxed warning, the FDA’s strongest safety alert, emphasizes a serious potential side effect – in this case, liver injury. While the FDA maintains that veozah’s overall benefits outweigh the risks for many patients, the warning underscores the need for careful monitoring. “This warning underscores the need for careful monitoring,” said Dr. [Alex Reed Name], a leading expert in [Alex Reed’s area of expertise]. “While the FDA emphasizes that the overall benefit-risk profile of Veozah remains positive, this warning highlights a serious potential side effect that needs to be taken seriously.”

Recognizing the Symptoms

Patients taking Veozah should be aware of potential signs of liver problems, which can include fatigue, nausea, itching, jaundice (yellowing of the skin or eyes), light-colored stools, and dark urine. If any of these symptoms develop, immediate contact with a healthcare provider is crucial.

Guidance for Healthcare Providers

In light of this warning, healthcare providers should thoroughly discuss the potential liver risks of Veozah with their patients before prescribing it. Obtaining informed consent and closely monitoring liver function tests throughout treatment are essential steps.

Manufacturer’s Response and Patient Advice

Astellas, the manufacturer of Veozah, released a statement reassuring patients about the drug’s safety profile. Dr. [Alex Reed Name] acknowledged this reassurance while emphasizing the importance of ongoing post-marketing surveillance and open communication between regulatory bodies, manufacturers, and healthcare providers to ensure patient safety. “while the FDA warning highlights a serious potential risk, Veozah remains a viable treatment option for many women suffering from hot flashes,” Dr. [Alex Reed Name] explained. “This case highlights the importance of ongoing post-marketing surveillance and open interaction between regulatory bodies, manufacturers, and healthcare providers to ensure patient safety.” Dr. [Alex Reed Name] encouraged women currently taking Veozah or considering it for hot flash relief to have an open and honest conversation with their healthcare providers about the potential risks and benefits. By working together, they can make informed decisions about their treatment plan.

When Are Single Page Applications Not the Best Choice?

Single Page Applications (SPAs) have become increasingly popular for their ability to deliver smooth, dynamic user experiences without full page reloads.Though, like any technological approach, SPAs aren’t universally suitable for every project. There are situations were customary multi-page applications might be a better fit. Understanding these scenarios can help developers make informed decisions during the early stages of a project. A recent Reddit discussion delved into this very topic, exploring the nuances of when SPAs might not be the optimal solution.The conversation highlighted several key considerations. For instance, projects with complex server-side rendering requirements might find SPAs challenging. SPAs typically handle rendering on the client-side,which can be less efficient for SEO and initial load times. Similarly, large, intricate applications might benefit from the modularity and structure of a multi-page architecture. Ultimately, the decision of whether to use a SPA comes down to a careful evaluation of the project’s specific needs and constraints. While SPAs offer undeniable advantages, recognizing their limitations is crucial for successful progress. ### Background on Veozah

FDA Issues Warning on Liver Injury Risk Associated with Fezolinetant

The U.S.Food and Drug Administration (FDA) has issued a warning regarding a rare but serious risk of liver injury associated with fezolinetant. This medication is used to treat moderate to severe hot flashes associated with menopause. The warning follows a postmarketing case report of a serious drug-induced liver injury linked to fezolinetant use. The FDA advises patients taking fezolinetant to immediately stop taking the medication and contact their healthcare provider if they experience any symptoms suggestive of liver problems.These symptoms may include jaundice (yellowing of the skin or eyes), dark urine, pale stools, abdominal pain, loss of appetite, nausea, or fatigue.

Recommendations for Healthcare Providers

Healthcare providers are urged to conduct baseline liver blood tests before prescribing fezolinetant. These tests should assess liver function and include measurements of serum ALT, serum AST, serum ALP, total serum bilirubin, and direct serum bilirubin. The medication should not be prescribed if the concentration of ALT, AST, or total bilirubin is at or above twice the upper limit of normal (ULN). During treatment,regular follow-up liver blood tests are recommended. these should be performed monthly for the first three months of treatment and then again at months six and nine. The FDA recommends discontinuing fezolinetant if transaminases exceed five times the ULN, or if transaminases exceed three times the ULN alongside a total bilirubin level greater than twice the ULN. The FDA has issued a boxed warning for Veozah (fezolinetant), a medication prescribed for moderate to severe hot flashes experienced by menopausal women. This warning highlights a potential risk of liver injury associated with the drug. Understanding the FDA Warning The boxed warning is the most serious alert the FDA can issue, indicating a significant potential side effect. Although the FDA maintains that Veozah’s overall benefits generally outweigh the risks, the warning emphasizes the importance of vigilant monitoring. Recognizing Symptoms of Liver Injury Patients taking Veozah should be aware of potential signs of liver problems, including:

• Fatigue
• Nausea
• Itching
• Jaundice (yellowing of the skin or eyes)
• Light-colored stools
• dark urine

If any of these symptoms appear, immediate contact with a healthcare provider is crucial. Guidance for Healthcare Providers In light of the FDA warning, healthcare providers should take the following steps: * Thoroughly discuss the potential liver risks of Veozah with their patients. * Obtain informed consent before prescribing the medication. * Closely monitor liver function tests during treatment. Manufacturer’s Response and Patient Advice astellas, the manufacturer of Veozah, has released a statement reassuring patients about the drug’s safety profile. However, it’s essential to remember that while the FDA warning highlights a serious potential risk, Veozah remains a viable treatment option for many women experiencing hot flashes. “This case underscores the importance of ongoing post-marketing surveillance and open communication between regulatory bodies, manufacturers, and healthcare providers to ensure patient safety,” states Dr. [Alex Reed Name],a leading expert in [Alex Reed’s area of expertise]. Dr. [Alex Reed name] advises women currently taking Veozah or considering it for hot flash relief to have an open and honest conversation with their healthcare providers about the potential risks and benefits. “By working together,” Dr. [Alex Reed Name] emphasizes, “they can make informed decisions about their treatment plan.” In this insightful conversation, we explore compelling insights shared by Dr.[Alex Reed Name], a renowned expert in [Alex Reed’s Field]. “my pleasure,” Dr. [Alex Reed Name] responds, marking the beginning of a engaging exchange.

The video discussion delves into a range of topics related to [Alex Reed’s Field], offering valuable perspectives and thought-provoking ideas. astellas pharma, the manufacturer of Veozah, stated, “It’s meaningful to note that the overall benefit-risk of Veozah has not changed and remains positive, but we⁢ want to further ensure that patients and healthcare providers are aware of the‌ potential side​ effects of Veozah, and the hepatic laboratory testing, as it relates to its⁣ benefit to help reduce moderate to severe vasomotor symptoms (VMS) due ⁢to menopause. We remain confident in the overall safety profile of Veozah and its ability to provide appropriate patients with a nonhormonal treatment option ​for​ moderate to ‌severe VMS due to menopause.”

FDA Issues Warning on Liver Injury Risk associated with Veozah

The U.S. Food and Drug Administration (FDA) has issued a warning regarding a rare but serious risk of liver injury associated with Veozah (fezolinetant). This medication, approved in May 2023, is used to treat moderate to severe hot flashes caused by menopause. The warning follows a case of serious drug-induced liver injury reported after a patient took Veozah. The FDA advises patients taking Veozah to stop taking the medication and immediately contact their healthcare provider if they experience any symptoms of liver problems. These symptoms may include jaundice (yellowing of the skin or eyes), dark urine, pale stools, abdominal pain, loss of appetite, nausea, or fatigue.

Recommendations for Healthcare Providers

Healthcare providers are urged to conduct baseline liver blood tests before prescribing Veozah. These tests should assess liver function and include measurements of serum ALT, serum AST, serum ALP, total serum bilirubin, and direct serum bilirubin. Veozah should not be prescribed if the concentration of ALT,AST,or total bilirubin is at or above twice the upper limit of normal. During treatment, regular follow-up liver blood tests are recommended. These should be performed monthly for the first three months of treatment, and then again at months six and nine. The FDA recommends discontinuing Veozah if transaminases exceed five times the upper limit of normal, or if transaminases exceed three times the upper limit of normal alongside a total bilirubin level greater than twice the upper limit of normal.

FDA Issues Boxed Warning for Veozah Due to Liver Injury Risk

The U.S. Food and Drug administration (FDA) recently issued a boxed warning for Veozah (fezolinetant), a medication used to treat moderate to severe hot flashes in menopausal women. This warning comes after reports of potential liver injury associated with the drug. While Veozah remains a viable treatment option for many, this new warning highlights the importance of careful monitoring and awareness of potential side effects.

Understanding the risks

The boxed warning is the strongest warning the FDA can issue, signifying a serious potential side effect. In this case,the FDA emphasizes the risk of rare but serious liver injury. “While the overall benefit-risk profile of Veozah remains positive, this warning underscores the need for careful monitoring,” explained Dr. [Alex Reed Name],a leading expert in [Alex Reed’s area of expertise]. Patients taking Veozah should be aware of potential symptoms of liver problems, such as fatigue, nausea, itching, jaundice (yellowing of the skin or eyes), light-colored stools, and dark urine. Dr. [Alex Reed Name] urges patients to “immediately contact their healthcare provider if they experience any of these symptoms.”

Steps for Healthcare Providers and Patients

Dr.[Alex Reed Name] recommends that healthcare providers discuss the potential liver risks of Veozah with their patients, obtain informed consent before prescribing it, and closely monitor liver function tests during treatment. Astellas, the manufacturer of Veozah, issued a statement reassuring patients about the drug’s safety profile. Dr. [Alex Reed Name] acknowledges this while emphasizing the importance of ongoing post-marketing surveillance and open communication between regulatory bodies,manufacturers,and healthcare providers to ensure patient safety.

Making Informed Decisions

Dr. [Alex Reed Name] advises women who are currently taking Veozah or considering it for hot flash relief to have an open and honest conversation with their healthcare provider about the potential risks and benefits. “By working together,” Dr. [Alex Reed name] says, “they can make informed decisions about their treatment plan.”

Understanding a Critical Issue

We recently sat down with Dr. [Alex Reed Name] to discuss a pressing issue.

“My pleasure,” Dr. [Alex Reed Name] responded. While emphasizing that the overall benefit-risk profile of Veozah remains positive, the FDA highlights the importance ​of increasing awareness among both patients and healthcare providers about the‌ potential for‌ liver injury.The agency recommends monitoring liver function tests during⁣ treatment.

FDA Issues Warning on Liver Injury Risk Associated with Veozah

The U.S. Food and Drug Administration (FDA) has issued a warning regarding a rare but serious risk of liver injury associated with Veozah (fezolinetant), a medication used to treat moderate to severe hot flashes caused by menopause. This warning follows a postmarketing case of serious drug-induced liver injury linked to veozah use. The FDA advises patients taking Veozah to immediately stop taking the medication and contact their healthcare provider if they experience any symptoms suggestive of liver problems. These symptoms may include jaundice (yellowing of the skin or eyes), dark urine, pale stools, abdominal pain, loss of appetite, nausea, or fatigue.

Recommendations for Healthcare Providers

Healthcare providers are urged to conduct baseline liver blood tests before prescribing Veozah.These tests should assess liver function and include measurements of serum ALT, serum AST, serum ALP, total serum bilirubin, and direct serum bilirubin. Astellas Pharma, the manufacturer of Veozah, stated, “It’s meaningful to note that the overall benefit-risk of Veozah has not changed and remains positive, but we want to further ensure that patients and healthcare providers are aware of the potential side effects of veozah, and the hepatic laboratory testing, as it relates to its benefit to help reduce moderate to severe vasomotor symptoms (VMS) due to menopause. We remain confident in the overall safety profile of Veozah and its ability to provide appropriate patients with a nonhormonal treatment option for moderate to severe VMS due to menopause.”

Background on Veozah

Veozah received FDA approval on May 12, 2023, becoming the first neurokinin 3 receptor antagonist approved for treating VMS associated with menopause. Approval was based on data from the phase 3 BRIGHT SKY trial program, which encompassed over 3,000 patients across the US, Canada, and Europe. The trial demonstrated the safety and efficacy of fezolinetant in managing VMS related to menopause. Prior to the recent warning, the medication label already included a caution regarding the risk of elevated liver enzymes. Patients were advised to undergo baseline liver function tests before starting treatment and then every three months during the nine-month regimen. In addition, the FDA previously stated that Veozah should not be used in combination with CYP1A2 inhibitors and advised patients with cirrhosis, severe renal damage, or end-stage renal disease against taking the medication. On September 12, 2024, the FDA issued a Drug Safety Dialog adding a warning regarding liver injury to the medication label.

FDA Issues Warning on Veozah Due to Liver Injury Risk

The U.S. Food and Drug administration (FDA) recently issued a boxed warning for Veozah (fezolinetant), a medication used to treat moderate to severe hot flashes associated with menopause. This warning comes after reports of potential serious liver injury in some patients taking the drug. The boxed warning is the strongest warning the FDA can issue, highlighting a serious potential side effect. While the FDA emphasizes that the overall benefit-risk profile of veozah remains positive, this warning underscores the need for careful monitoring of patients taking the medication.

What Patients Should No

Dr. [Alex Reed Name], a leading expert in [Alex Reed’s area of expertise], explained that patients taking Veozah should be aware of potential signs of liver problems. “Patients should be vigilant for symptoms such as fatigue, nausea, itching, jaundice (yellowing of the skin or eyes), light-colored stools, and dark urine,” Dr. [Alex Reed Name] advised. “If they experience any of these symptoms, they should immediately contact their healthcare provider.”

Guidance for Healthcare Providers

In light of this warning,Dr. [Alex Reed Name] stressed the importance of healthcare providers discussing the potential liver risks of Veozah with their patients before prescribing the medication. Obtaining informed consent and closely monitoring liver function tests during treatment are crucial steps to ensure patient safety.

Manufacturer’s Response

Astellas, the manufacturer of Veozah, issued a statement reassuring patients about the drug’s safety profile.Dr. [Alex Reed Name] acknowledged the importance of ongoing post-marketing surveillance and open communication between regulatory bodies, manufacturers, and healthcare providers to ensure patient safety. “This case highlights the importance of vigilance and collaboration in addressing potential drug safety concerns,” Dr. [Alex Reed Name] concluded.

Understanding the risks and Benefits of Veozah for Hot Flashes

Many women seeking relief from hot flashes are turning to veozah, a new treatment option. Though, like any medication, Veozah comes with potential risks and benefits that warrant careful consideration.

Leading medical professionals emphasize the importance of open communication between patients and their healthcare providers. “I encourage women to have an open and honest conversation with their healthcare providers about the potential risks and benefits of Veozah,” advises Dr. [Alex Reed Name]. “by working together, they can make informed decisions about their treatment plan.” The FDA’s review involved a case reported to the FDA adverse Event reporting System (FAERS) database where a‍ patient experienced symptoms of fatigue, nausea, itching, ⁤jaundice, light-colored stools, and dark urine within 40 days of starting fezolinetant. The patient also exhibited elevated liver enzymes and ⁤bilirubin levels. After‍ discontinuing the medication, the patient’s symptoms resolved, and liver function⁣ tests returned to normal, ​leading the FDA ‍to conclude that the liver injury was likely caused by Veozah.

FDA Issues Warning on Liver Injury Risk Associated with Fezolinetant

The U.S. Food and Drug administration (FDA) has issued a warning about a rare but serious risk of liver injury associated with fezolinetant, a medication used to treat moderate to severe hot flashes caused by menopause. This warning follows a postmarketing case of serious drug-induced liver injury linked to fezolinetant use. Patients taking fezolinetant should immediately stop taking the medication and contact their healthcare provider if they experience any symptoms suggestive of liver problems. These symptoms can include jaundice (yellowing of the skin or eyes), dark urine, pale stools, abdominal pain, loss of appetite, nausea, or fatigue.

recommendations for Healthcare providers

Healthcare providers are urged to be aware of the potential for liver injury associated with fezolinetant and to monitor liver function tests in patients taking the medication. Patients should be informed about the signs and symptoms of liver injury and advised to seek immediate medical attention if they experience any of these symptoms.

Background on Veozah

fezolinetant, marketed under the brand name veozah, was approved by the FDA on may 12, 2023, becoming the first neurokinin 3 receptor antagonist approved for treating vasomotor symptoms (VMS) associated with menopause. Approval was based on data from the phase 3 BRIGHT SKY trial program, which involved over 3000 patients across the US, Canada, and europe.The trial demonstrated the safety and efficacy of fezolinetant in managing VMS related to menopause. Even before the recent warning, the medication label included a caution regarding the risk of elevated liver enzymes. Patients were advised to undergo baseline liver function tests before starting treatment and then every three months during the nine-month regimen. The FDA had previously stated that Veozah should not be used in combination with CYP1A2 inhibitors and advised against its use in patients with cirrhosis, severe renal damage, or end-stage renal disease. On September 12, 2024, the FDA issued a Drug Safety Communication adding a warning regarding liver injury to the medication label. While emphasizing that the overall benefit-risk profile of Veozah remains positive, Astellas Pharma, the manufacturer of Veozah, stressed the importance of increasing awareness among healthcare providers and patients about the potential for liver injury. The company reiterates that the overall safety profile of Veozah remains positive. conduct baseline liver blood tests before ‍prescribing fezolinetant. These tests should⁣ assess liver function and include measurements of serum‌ ALT, serum AST, serum ALP, total serum⁣ bilirubin, and direct serum bilirubin. The⁢ medication should not‌ be prescribed if the ​concentration of ALT, AST, or total bilirubin is at or above twice the upper limit of normal (ULN). During treatment, regular follow-up liver blood tests are recommended.These should be ⁣performed monthly for the first three months⁤ of treatment, and then again⁣ at months six and nine. If transaminases exceed five times the ULN,or if transaminases exceed three times the ULN alongside a total bilirubin level ​greater than twice the ULN, the FDA recommends discontinuing‍ fezolinetant. Fezolinetant, sold under ⁢the brand name Veozah, was initially approved by the FDA in may 2023 ‌to treat moderate ⁢to severe hot flashes in ⁢menopausal women. This new warning underscores the importance of careful monitoring and awareness of potential side effects when prescribing this‍ medication.
## Archyde Interview: Veozah’s Liver Injury Risk



**Interviewer:**‌ Welcome back ⁣to Archyde.Today, we’re discussing the recent FDA warning issued for Veozah (fezolinetant), a medication used to treat hot flashes associated with menopause.Joining me to discuss this is Dr. [Alex Reed Name],a​ leading ​expert in [Alex Reed’s area of expertise]. Dr. [Alex Reed name], thanks for being here.



**Dr.[Alex Reed Name]:** Thank ⁢you for having me.



**Interviewer:** The FDA issued​ a boxed warning ‌for ⁣Veozah due to a potential risk of liver injury. Can you explain what this ​means for patients currently taking the medication?



**Dr.[Alex Reed Name]:** the boxed warning is the ⁤strongest warning the ⁣FDA​ can issue. It ​highlights⁣ a serious ⁣potential⁤ side effect,in this case,liver injury. While the FDA emphasizes that ⁤the ⁣overall benefit-risk profile of Veozah remains​ positive, ⁣this warning underscores the need for careful monitoring. [ [1](https://www.drugs.com/fda/fda-adds-boxed-warning-veozah-fezolinetant-highlight-known-risk-rare-but-serious-liver-injury-14717.html) ]



**Interviewer:** Could you elaborate on the symptoms patients should watch out for?



**Dr. [Alex Reed Name]:** ​Patients should be vigilant for signs of liver problems such as ‌fatigue,⁣ nausea, itching, jaundice (yellowing of the skin or eyes), light-colored stools, ⁣and ⁤dark urine. If they ‌experience any of these ⁢symptoms, they should immediately contact their healthcare provider.



**Interviewer:** what ‌steps should healthcare providers take ⁣in light of this warning?



**Dr. [Alex Reed Name]:** Healthcare⁤ providers should discuss⁤ the potential liver risks ⁤of Veozah with their patients, ⁣obtain informed consent before prescribing it, and ⁤closely monitor liver function tests during treatment.



**Interviewer:** Astellas, the ​manufacturer of Veozah, issued a ​statement reassuring patients about the drug’s safety⁢ profile. What are your thoughts on⁣ their stance?



**Dr. ​ [Alex Reed Name]:** Its⁢ vital to acknowledge that while the FDA warning highlights a serious potential risk, Veozah remains⁤ a viable treatment option for many women suffering from hot flashes.This case highlights ​the importance of ongoing post-marketing ⁣surveillance and open interaction between regulatory bodies,manufacturers,and healthcare providers to ensure ‍patient safety.



**Interviewer:** ⁢What advice ⁣would you give to women who are currently taking Veozah or considering it for hot flash relief?



**Dr. ​ [Alex Reed Name]:** I ​encourage women to have an open and honest conversation‌ with their healthcare providers about the potential risks and benefits of Veozah.By working together,they can make informed decisions about their treatment plan.



**Interviewer:** Thank⁣ you for sharing your‌ expertise on this critically important issue, Dr. [Alex Reed Name].



**Dr.⁢ [Alex Reed Name]:**⁤ My pleasure.

The U.S.Food and Drug⁢ Administration (FDA) has issued a boxed Warning, its most prominent warning, for Veozah (fezolinetant), a medication used to treat moderate to severe vasomotor symptoms (VMS) associated with ⁤menopause. This decision follows a recent review of a postmarketing case report indicating a rare but serious risk⁤ of liver injury associated with the drug.

FDA Issues warning on Liver Injury Risk Associated with Veozah

The U.S. Food and Drug Administration (FDA) has issued a warning regarding a rare but serious risk of liver injury associated with Veozah (fezolinetant),a medication used to treat moderate to severe hot flashes caused by menopause. This warning follows a reported case of serious drug-induced liver injury in a patient taking Veozah. The FDA reviewed a case reported to the FDA Adverse event Reporting System (FAERS) database where a patient experienced symptoms like fatigue, nausea, itching, jaundice, light-colored stools, and dark urine within 40 days of starting Veozah. Lab tests showed elevated liver enzymes and bilirubin levels.After the patient stopped taking Veozah, their symptoms resolved, and liver function tests returned to normal. The FDA concluded that the liver injury was likely caused by the medication. While the FDA emphasizes that the overall benefit-risk profile of Veozah remains positive, they stress the importance of raising awareness among both patients and healthcare providers about the potential for liver injury. The agency recommends monitoring liver function tests during treatment. Astellas Pharma, the manufacturer of Veozah, stated, “It’s meaningful to note that the overall benefit-risk of veozah has not changed and remains positive, but we want to further ensure that patients and healthcare providers are aware of the potential side effects of Veozah, and the hepatic laboratory testing, as it relates to its benefit to help reduce moderate to severe vasomotor symptoms (VMS) due to menopause. We remain confident in the overall safety profile of Veozah and its ability to provide appropriate patients with a nonhormonal treatment option for moderate to severe VMS due to menopause.”

Background on Veozah

Veozah received FDA approval on may 12, 2023, becoming the first neurokinin 3 receptor antagonist approved for treating vasomotor symptoms (VMS) associated with menopause. Approval was based on data from the phase 3 BRIGHT SKY trial program, which included over 3,000 patients across the US, Canada, and Europe.The trial demonstrated the safety and efficacy of fezolinetant in managing VMS related to menopause. Before the recent warning, the medication label already included a caution regarding the risk of elevated liver enzymes. Patients were advised to undergo baseline liver function tests before starting treatment and then every three months during the nine-month regimen. The FDA had also previously stated that Veozah should not be used in combination with CYP1A2 inhibitors and advised against its use in patients with cirrhosis,severe renal damage,or end-stage renal disease. On September 12, 2024, the FDA issued a Drug Safety dialog adding a warning regarding liver injury to the medication label.

FDA Issues Boxed Warning for Veozah Due to Potential Liver Injury Risk

The FDA recently issued a boxed warning for Veozah (fezolinetant), a medication used to treat hot flashes associated with menopause. This is the strongest warning the FDA can issue and highlights a serious potential side effect: liver injury. While the FDA emphasizes that the overall benefit-risk profile of Veozah remains positive, this warning underscores the need for careful monitoring of patients taking the drug.

Understanding the Risk for patients

“Patients taking Veozah should be aware of the potential for liver injury and watch for symptoms such as fatigue, nausea, itching, jaundice (yellowing of the skin or eyes), light-colored stools, and dark urine,” says Dr. [Alex Reed Name], a leading expert in [Alex Reed’s area of expertise]. “If they experience any of these symptoms, they should immediately contact their healthcare provider.”

Guidance for Healthcare Providers

“Healthcare providers are urged to conduct baseline liver blood tests before prescribing fezolinetant,” advises Dr. [Alex Reed Name].”These tests should assess liver function and include measurements of serum ALT,serum AST,serum ALP,total serum bilirubin,and direct serum bilirubin. The medication should not be prescribed if the concentration of ALT, AST, or total bilirubin is at or above twice the upper limit of normal (ULN).” During treatment, regular follow-up liver blood tests are recommended. These should be performed monthly for the first three months of treatment, and then again at months six and nine. If transaminases exceed five times the ULN, or if transaminases exceed three times the ULN alongside a total bilirubin level greater than twice the ULN, the FDA recommends discontinuing fezolinetant. Fezolinetant, sold under the brand name Veozah, was initially approved by the FDA in May 2023 to treat moderate to severe hot flashes in menopausal women. This new warning underscores the importance of careful monitoring and awareness of potential side effects when prescribing this medication.

Potential Liver Risks Associated with veozah: What Women Need to Know

A recent FDA warning has highlighted a potential risk of liver injury associated with Veozah, a medication prescribed for managing hot flashes in menopausal women. This news has raised concerns among patients and healthcare professionals alike.

Balancing Risks and Benefits

While the FDA warning underscores a serious potential side effect, medical experts emphasize that Veozah can still be a valuable treatment option for many women struggling with hot flashes.

“It’s vital to acknowledge that while the FDA warning highlights a serious potential risk, Veozah remains a viable treatment option for many women suffering from hot flashes…”

— Dr. [Alex Reed Name]

dr. [Alex Reed Name] stresses the importance of ongoing monitoring and open communication between healthcare providers, manufacturers, and regulatory bodies to ensure patient safety.

Informed Decision-Making

for women currently taking Veozah or considering it for hot flash relief, Dr. [Alex Reed Name] recommends having an open and honest conversation with their healthcare provider.

“I encourage women to have an open and honest conversation with their healthcare providers about the potential risks and benefits of veozah. By working together, they can make informed decisions about their treatment plan.”

— Dr.[Alex Reed Name]

## FDA ⁣Issues Boxed Warning for Veozah (Fezolinetant) Due‍ to Liver Injury Risk

FDA Issues Warning on liver Injury Risk Associated with Fezolinetant

The U.S. Food and Drug Administration (FDA) has issued a warning regarding a rare but serious risk of liver injury associated with Veozah (fezolinetant), a medication used to treat moderate to severe vasomotor symptoms (VMS) associated with menopause. This decision follows a review of a postmarketing case report submitted to the FDA adverse Event Reporting System (FAERS) database. The case involved a patient who developed symptoms including fatigue, nausea, itching, jaundice, light-colored stools, and dark urine within 40 days of starting fezolinetant. the patient also exhibited elevated liver enzymes and bilirubin levels. After discontinuing the medication, the patient’s symptoms resolved, and liver function tests returned to normal, leading the FDA to conclude that Veozah was likely the cause of the liver injury. While emphasizing that the overall benefit-risk profile of Veozah remains positive, the FDA is urging increased awareness among both patients and healthcare providers about the potential for liver injury. The agency recommends monitoring liver function tests during treatment. “It’s meaningful to note that the overall benefit-risk of Veozah has not changed and remains positive,” stated Astellas Pharma, the manufacturer of Veozah. “But we want to further ensure that patients and healthcare providers are aware of the potential side effects of Veozah, and the hepatic laboratory testing, as it relates to its benefit to help reduce moderate to severe vasomotor symptoms (VMS) due to menopause. We remain confident in the overall safety profile of Veozah and its ability to provide appropriate patients with a nonhormonal treatment option for moderate to severe VMS due to menopause.”

Background on Veozah

Fezolinetant received FDA approval on May 12, 2023, marking it the first neurokinin 3 receptor antagonist approved for treating VMS associated with menopause. Approval was based on data from the phase 3 BRIGHT SKY clinical trial program, which enrolled over 3,000 patients across the US, Canada, and Europe. The trial demonstrated the safety and efficacy of fezolinetant in managing VMS related to menopause. prior to this recent warning, the medication label already included a caution regarding the risk of elevated liver enzymes. Patients were advised to undergo baseline liver function tests before starting treatment and then every three months during the nine-month regimen. The FDA also previously stated that Veozah should not be used in combination with CYP1A2 inhibitors and advised against its use in patients with cirrhosis, severe renal damage, or end-stage renal disease. On September 12, 2024, the FDA issued a Drug Safety Communication adding a warning regarding liver injury to the medication label.

FDA Issues Boxed Warning for Veozah (Fezolinetant) Due to Liver Injury Risk

The U.S. Food and Drug Administration (FDA) has issued a boxed warning for Veozah (fezolinetant), a medication used to treat moderate to severe hot flashes associated with menopause. This warning comes after a reported case of serious drug-induced liver injury linked to fezolinetant use. While the FDA maintains that Veozah’s overall benefits still outweigh the risks for many patients, this warning underscores the need for close monitoring of patients taking the medication.

Understanding the Boxed Warning

A boxed warning is the strongest warning the FDA can issue. It highlights a serious potential side effect that may be rare but carries significant consequences. In this case, the boxed warning focuses on the potential for liver injury associated with Veozah. “The FDA emphasizes that the overall benefit-risk profile of Veozah remains positive,” states Dr. [Alex Reed Name], a leading expert in [Alex Reed’s area of expertise]. “However, this warning underscores the need for careful monitoring.”

Symptoms to Watch For

Patients taking Veozah should be on the lookout for any signs of liver problems and immediately contact their healthcare provider if they experience symptoms such as:

• Fatigue
• Nausea
• Itching
• Jaundice (yellowing of the skin or eyes)
• Dark urine
• Pale stools
• Abdominal pain
• loss of appetite

Recommendations for Healthcare Providers

The FDA recommends that healthcare providers perform baseline liver blood tests before prescribing veozah to assess liver function. These tests should include measurements of serum ALT, serum AST, serum ALP, total serum bilirubin, and direct serum bilirubin. veozah should not be prescribed if the concentration of ALT, AST, or total bilirubin is at or above twice the upper limit of normal (ULN). During treatment, regular follow-up liver blood tests are advised, with monthly testing for the first three months, followed by testing at months six and nine. If transaminases exceed five times the ULN, or if transaminases exceed three times the ULN alongside a total bilirubin level greater than twice the ULN, the FDA recommends discontinuing Veozah. Originally approved in May 2023, Veozah offered a new treatment option for managing menopausal hot flashes. This new warning emphasizes the importance of vigilant monitoring and awareness of potential side effects when prescribing this medication.

FDA Issues Warning on Veozah, a Drug Used to Treat Hot Flashes

The U.S. Food and Drug Administration (FDA) recently issued a warning about Veozah, a medication used to treat moderate to severe hot flashes associated with menopause. The warning comes after reports of potential serious liver damage in some patients taking the drug. The FDA advises patients taking Veozah to be alert for signs of liver problems, including dark urine, light-colored stools, nausea, abdominal pain, fatigue, and jaundice. Anyone experiencing these symptoms should contact their healthcare provider immediately.

What Does this Mean for Healthcare Providers?

According to Dr. [Alex Reed Name],a medical expert on the topic,healthcare providers need to thoroughly discuss the potential liver risks of Veozah with their patients. Obtaining informed consent before prescribing the medication is crucial. Additionally, Dr. [Alex Reed name] emphasizes the importance of closely monitoring liver function tests in patients taking Veozah.

Astellas’ Response

Astellas,the manufacturer of Veozah,has released a statement reassuring patients about the drug’s safety profile. While acknowledging the FDA warning, Astellas maintains that Veozah remains a viable treatment option for many women struggling with hot flashes. Dr. [Alex Reed Name] highlights the significance of ongoing surveillance and open communication between regulatory bodies, manufacturers, and healthcare providers in ensuring patient safety. This case underscores the importance of continued monitoring even after a drug has been approved for market.

Advice for Patients

Dr. [Alex Reed Name] encourages women taking or considering Veozah to have an open and honest conversation with their healthcare provider about both the risks and benefits of the drug.Through this dialogue, patients can make well-informed decisions about their treatment plans, taking into account their individual medical history and needs.

FDA Issues Warning on Liver Injury Risk Associated with Fezolinetant

The U.S.Food and Drug Administration (FDA) has issued a warning regarding a rare but serious risk of liver injury associated with veozah (fezolinetant), a medication used to treat moderate to severe vasomotor symptoms (VMS) associated with menopause. This decision follows a review of a postmarketing case report submitted to the FDA Adverse Event Reporting System (FAERS) database. The case involved a patient who developed symptoms including fatigue, nausea, itching, jaundice, light-colored stools, and dark urine within 40 days of starting fezolinetant. The patient also exhibited elevated liver enzymes and bilirubin levels. After discontinuing the medication, the patient’s symptoms resolved, and liver function tests returned to normal, leading the FDA to conclude that Veozah was likely the cause of the liver injury. While emphasizing that the overall benefit-risk profile of Veozah remains positive, the FDA is urging increased awareness among both patients and healthcare providers about the potential for liver injury. The agency recommends monitoring liver function tests during treatment. “It’s meaningful to note that the overall benefit-risk of Veozah has not changed and remains positive,” stated Astellas Pharma,the manufacturer of Veozah. “But we want to further ensure that patients and healthcare providers are aware of the potential side effects of Veozah, and the hepatic laboratory testing, as it relates to its benefit to help reduce moderate to severe vasomotor symptoms (VMS) due to menopause. We remain confident in the overall safety profile of Veozah and its ability to provide appropriate patients with a nonhormonal treatment option for moderate to severe VMS due to menopause.”

Background on Veozah

Fezolinetant received FDA approval on May 12, 2023, marking it the first neurokinin 3 receptor antagonist approved for treating VMS associated with menopause. Approval was based on data from the phase 3 BRIGHT SKY clinical trial program, which enrolled over 3,000 patients across the US, Canada, and Europe. The trial demonstrated the safety and efficacy of fezolinetant in managing VMS related to menopause. Prior to this recent warning, the medication label already included a caution regarding the risk of elevated liver enzymes. Patients were advised to undergo baseline liver function tests before starting treatment and then every three months during the nine-month regimen.The FDA also previously stated that Veozah should not be used in combination with CYP1A2 inhibitors and advised against its use in patients with cirrhosis, severe renal damage, or end-stage renal disease. On September 12, 2024, the FDA issued a Drug safety Communication adding a warning regarding liver injury to the medication label.

FDA Issues boxed Warning for Veozah (Fezolinetant) Due to Liver Injury Risk

The U.S. Food and Drug Administration (FDA) has issued a boxed warning for Veozah (fezolinetant), a medication used to treat moderate to severe hot flashes associated with menopause. This warning comes after a reported case of serious drug-induced liver injury linked to fezolinetant use. While the FDA maintains that Veozah’s overall benefits still outweigh the risks for many patients, this warning underscores the need for close monitoring of patients taking the medication.

Understanding the Boxed Warning

A boxed warning is the strongest warning the FDA can issue. It highlights a serious potential side effect that may be rare but carries significant consequences. in this case, the boxed warning focuses on the potential for liver injury associated with Veozah. “The FDA emphasizes that the overall benefit-risk profile of Veozah remains positive,” states Dr.[Alex Reed Name], a leading expert in [Alex Reed’s area of expertise]. “However, this warning underscores the need for careful monitoring.”

Symptoms to Watch For

Patients taking Veozah should be on the lookout for any signs of liver problems and immediately contact their healthcare provider if they experience symptoms such as:

• Fatigue
• Nausea
• Itching
• Jaundice (yellowing of the skin or eyes)
• Dark urine
• Pale stools
• Abdominal pain
• Loss of appetite

Recommendations for Healthcare Providers

The FDA recommends that healthcare providers perform baseline liver blood tests before prescribing Veozah to assess liver function. These tests should include measurements of serum ALT,serum AST,serum ALP,total serum bilirubin,and direct serum bilirubin. Veozah should not be prescribed if the concentration of ALT, AST, or total bilirubin is at or above twice the upper limit of normal (ULN). during treatment, regular follow-up liver blood tests are advised, with monthly testing for the first three months, followed by testing at months six and nine. If transaminases exceed five times the ULN, or if transaminases exceed three times the ULN alongside a total bilirubin level greater than twice the ULN, the FDA recommends discontinuing Veozah. Originally approved in May 2023, Veozah offered a new treatment option for managing menopausal hot flashes. This new warning emphasizes the importance of vigilant monitoring and awareness of potential side effects when prescribing this medication.

FDA Issues Warning on Veozah, a Drug Used to Treat Hot Flashes

The U.S. Food and Drug Administration (FDA) recently issued a warning about Veozah, a medication used to treat moderate to severe hot flashes associated with menopause. The warning comes after reports of potential serious liver damage in some patients taking the drug. The FDA advises patients taking Veozah to be alert for signs of liver problems, including dark urine, light-colored stools, nausea, abdominal pain, fatigue, and jaundice. Anyone experiencing these symptoms should contact their healthcare provider immediately.

What Does this Mean for Healthcare Providers?

According to Dr. [Alex Reed Name], a medical expert on the topic, healthcare providers need to thoroughly discuss the potential liver risks of Veozah with their patients. obtaining informed consent before prescribing the medication is crucial. Additionally, Dr. [Alex Reed Name] emphasizes the importance of closely monitoring liver function tests in patients taking Veozah.

Astellas’ Response

Astellas, the manufacturer of Veozah, has released a statement reassuring patients about the drug’s safety profile. While acknowledging the FDA warning, Astellas maintains that Veozah remains a viable treatment option for many women struggling with hot flashes. Dr. [Alex Reed Name] highlights the significance of ongoing surveillance and open communication between regulatory bodies, manufacturers, and healthcare providers in ensuring patient safety. This case underscores the importance of continued monitoring even after a drug has been approved for market.

Advice for Patients

Dr. [Alex Reed Name] encourages women taking or considering Veozah to have an open and honest conversation with their healthcare provider about both the risks and benefits of the drug. Through this dialogue, patients can make well-informed decisions about their treatment plans, taking into account their individual medical history and needs.

This is a good start to an informative article about the FDA warning on Veozah. Here are some suggestions to make it even better:



**Content:**



* **Expand on the impact:** Discuss the potential consequences of liver injury for patients,and how this warning might affect their treatment decisions.

* **Include quotes from patients:** If possible, incorporate quotes from patients who have experienced liver problems while taking Veozah or who are concerned about this new warning. This will add a personal dimension to the story.

* **elaborate on the FDA’s review process:** Briefly explain how the FDA investigates Adverse Event Reports and what factors they consider when issuing warnings.

* **Provide more detail on Astellas’ response:** What specific steps is the company taking to address the FDA’s warning? Are they conducting further studies?



**Structure:**



* **Break up the text:** Use more subheadings to make the article easier to read and scan.

* **Add bullet points or lists:** These can be helpful for summarizing key data, such as symptoms to watch for or recommendations for healthcare providers.





* **Include visuals:** Consider adding a photo of the Veozah medication or a graphic illustrating the liver.



**Tone:**



* **Maintain neutrality:** While it’s vital to highlight the seriousness of the warning, avoid sensationalism or overly alarmist language.

* **Focus on accurate reporting:** Stick to facts and evidence-based information from reliable sources.



**Overall:**



Your article is off to a good start in providing important information about this recent FDA warning.By expanding on these points and making the article more engaging, you can create a valuable resource for patients and healthcare providers alike.