Patients taking the anxiolytic Stresam must stop their treatment in the event of a rash or liver symptoms (jaundice, fatigue, stomach pain), alerts the Medicines Agency following serious reports.
Be careful if you are currently taking Stress®. On June 7, 2022, theNational Medicines Agency (ANSM) reported from severe skin reactions as well as liver symptoms such as a jaundice et stomach pain in patients taking l’etifoxine in 50mg capsules. Etifoxine is the active substance of the anxiolytic Stresam® as well as its generics. An analysis of pharmacovigilance data confirms that the risk of occurrence of these side effects is “very rare but can be serious“. As a result, the ANSM has informed health professionals that from now on the Stresam® and its generics are contraindicated in patients who have experienced skin reactions severe (drug hypersensitivity syndrome with eosinophiliasystemic symptoms (DRESS syndrome), syndrome de Stevens Johnson (SJS) or dermatitis generalized exfoliation) or severe forms of hepatitis or of hepatic cytolysisduring previous treatment with the same product.
What are the warning symptoms and what to do?
People on Stresam® or any of its generics should stopper la prise etifoxine and consult a doctor immediately if they have the following effects:
- severe skin or allergic reactions
- jaundice
- vomiting
- fatigue
- abdominal pain
- watery diarrhea.
If skin reactions to etifoxine or liver problems occur, treatment should never be restarted. In patients with risk factors for hepatic disorders, laboratory tests of liver function should be performed before the introduction of etifoxine and following the start of treatment. In-depth investigations should be considered if watery diarrhea occurs.
After how many days do the effects occur?
The skin reactions related to etifoxine usually occur following a few days and up to 1 month of treatment. “These skin reactions generally had a favorable outcome following discontinuation of treatment et no fatal cases linked to a serious skin reaction has been reported during treatment with etifoxine” specifies the ANSM. The hepatic reactions usually occur 2 to 4 weeks later initiation of treatment. They can be asymptomatic and only detected during biological analyses.
Source : Serious skin reactions and hepatic cytolysis with etifoxine 50 mg capsules (Stresam® and generics): new contraindications, warnings and precautions for use. ANSM. June 7, 2022
