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The European Medicines Agency (EMA) has come under fire for its recent decisions regarding the drug Accutane.
The agency, which is similar to the U.S. Food and Drug Administration, was criticized by the Lancet medical journal for the way that it approves some drugs, according to Reuters. An editorial in the journal criticized the EMA for not releasing documents that detailed the severe adverse reactions some people have experienced while taking the acne fighting drug Accutane. The EMA had been asked for the documents by an Irish citizen whose son committed suicide in 1997.
The EMA defended itself, saying that transparency regulations do not apply to serious adverse reaction reports. However, the European Ombudsman has asked the agency to reconsider its position.
Accutane, which is made by the drug company Roche, has caused controversy since it was released in 1982. Although it is a powerful acne fighter, Accutane can also cause some serious side effects, such as birth defects if taken during pregnancy and even mental health problems. Roche has vigorously fought Accutane lawsuits claiming mental side effects.
Roche is planning to stop selling Accutane because of generic competition.
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