The European Medicines Agency was originally studying the risks of Oxpreta as part of an investigation that began in July.
The European Medicines Agency said: “This investigation began when data from a clinical trial showed that the number of deaths was higher with Oxpreta compared to those who took a placebo.”
She added, “Another experiment showed that the total number of deaths was higher than expected, recommending against taking it.”
She stressed that doctors should also ask patients to stop using Oxpreta and “monitor them for any side effects after stopping treatment.”
Sickle cell disease is a group of hereditary blood disorders that cause a defect in the oxygen-carrying protein hemoglobin.
Healthy blood cells move through small blood vessels to carry oxygen to various parts of the body, according to the US Centers for Disease Control in the United States.
In a person with sickle cell disease, hemoglobin is abnormal, causing red blood cells to become hard, sticky, and sickle-like, obstructing blood flow.
Pfizer said on Wednesday that it “will voluntarily withdraw the drug Oxbryta from all markets in which it has been approved for sale.”
She explained that her decision “is based on all the clinical data that currently indicates that the overall benefit of Oxpreta no longer outweighs the risks to patients.”
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The European Medicines Agency’s call came a day after the American pharmaceutical company announced that it would voluntarily withdraw the drug “Oxpreta” from global markets, according to what Agence France-Presse reported.
Oxbryta is used to treat sickle cell disease, a potentially fatal blood disease that primarily affects millions of people of African, Middle Eastern, or South Asian origin.
The Amsterdam-based agency stated that it: “The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended that the license for the sale of Oxpreta be suspended.”
She added in a statement: “This step is being taken as a precautionary measure while the data is under review.”
Two studies showed that patients who used Oxpreta experienced a greater number of “vaso-occlusive attacks,” that is, severe pain and potential complications such as arthritis, kidney failure, and cerebrovascular accidents.
The European Medicines Agency was originally studying the risks of Oxpreta as part of an investigation that began in July.
The European Medicines Agency said: “This investigation began when data from a clinical trial showed that the number of deaths was higher with Oxpreta compared to those who took a placebo.”
She added, “Another experiment showed that the total number of deaths was higher than expected, recommending against taking it.”
She stressed that doctors should also ask patients to stop using Oxpreta and “monitor them for any side effects after stopping treatment.”
Sickle cell disease is a group of genetic blood disorders that cause a defect in the oxygen-carrying protein hemoglobin.
Healthy blood cells move through small blood vessels to carry oxygen to various parts of the body, according to the US Centers for Disease Control in the United States.
In a person with sickle cell disease, hemoglobin is abnormal, causing red blood cells to become hard, sticky, and sickle-like, obstructing blood flow.
Pfizer said on Wednesday that it “will voluntarily withdraw the drug Oxbryta from all markets in which it has been approved for sale.”
She explained that her decision “is based on all the clinical data that currently indicates that the overall benefit of Oxpreta no longer outweighs the risks to patients.”
