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European FDA to Release Side Effects

The European Unions version of the FDA last week announced that it will release drug safety information to the public, including information on the harmful side effects of Accutane. The decision comes after years of pressure from drug injury lawyers, citizens and medical journals to disclose details on bowel problems caused by Accutane.

Experts have linked Accutane to harmful bowel conditions such as Inflammatory Bowel Disease, Ulcerative Colitis and Crohns Disease. Although it was discontinued in June, 2009, the drug was sold to over 13 million people worldwide since 1982. Thousands of people have now filed claims alleging the drug caused their injuries.

The decision come after a ruling by the European Ombudsman in April that the European Medicines Agency (EMA) failed to adhere to the E.U.s transparency regulations which were put in place in 2001. Liam Grant, who has filed a lawsuit against Roche over his sons death, had sought the records but was initially denied.

In a very biased opinion, the EMA originally stated that the transparency laws didnt apply to adverse event reports for drugs, and that the drug safety information would be misleading to the general public and cause undo alarm.

Ombudsman Nikiforos Diamandouros disagreed, and ruled that the transparency rules applied to all of the EMAs documents, with few exceptions. He suggested the EMA provide additional context to go with any documents they thought may be misleading.

AccutaneRisks.com applauds the decision of the E.U.s actions and believes the United States FDA should operate with the same transparency to protect its citizens from future negative drug side effects.