Other safety alerts
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| European Union: EMA concludes review of anxiety medicine Stresam (etifoxine) |
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European Medicines Agency (EMA) announces that the Committee for Medicinal Products for Human Use (CHMP) has finalised its review of Stresam (etifoxine) and concluded that the medicine can continue to be used for the treatment of anxiety disorders, but it must not be used in patients who previously had severe skin reactions or severe liver problems after taking etifoxine.
During the review, the CHMP assessed all available data on the benefits and risks of Stresam, including the results of a study (AMETIS) on the efficacy of etifoxine in treating adjustment disorders with anxiety (where people have difficulty coping with stressful events). The CHMP also assessed safety data from clinical studies and post-marketing experience.
EMA concluded that Stresam can continue to be used for the treatment of anxiety disorders in some patients, but restrictions on its use have been put in place to minimise the risk of very rare but serious side effects that may occur with etifoxine. The medicine must not be used in patients who experienced severe skin reactions, including Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) syndrome, Stevens Johnson Syndrome (SJS) and generalised exfoliative dermatitis, or severe liver damage (severe hepatitis or cytolytic hepatitis) with previous etifoxine treatment, and treatment must be stopped if signs of skin reactions or liver problems appear. In patients at risk of liver problems, liver function tests should be performed before starting treatment and around one month after treatment has started. In addition, the company that markets Stresam will have to conduct a study to further characterise the effects of etifoxine in patients with anxiety.
The product information for Stresam will be updated to include the above recommendations.
Information for healthcare professionals:
- Very rare cases of severe dermatological reactions (including DRESS syndrome, SJS and generalised exfoliative dermatitis) and severe cytolytic hepatitis have been reported in patients treated with Stresam.
- Stresam is now contraindicated in patients who had severe dermatological reactions or severe cases of hepatitis or cytolytic hepatitis during previous treatment with etifoxine.
- Patients should be instructed to stop taking Stresam and seek urgent medical care if they experience: severe skin or allergic reactions; jaundice, vomiting, tiredness, abdominal pain, which can be indicative of severe liver problems; watery diarrhoea.
- In patients with risk factors for hepatic disorders (such as elderly patients, patients with medical history of previous viral hepatitis or other conditions), liver function tests should be performed before starting Stresam and around one month after treatment initiation.
- Few cases of lymphocytic colitis have been reported with the use of Stresam. Appropriate examinations should be considered in case of watery diarrhoea during treatment.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-24-27-january-2022
In Hong Kong, there is no registered pharmaceutical product containing etifoxine.
Ends/Monday, Jan 31, 2022
Issued at HKT 15:00
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