Data on Accutane Problems to be Released by EU Drug Agency

The European Union’s drug regulatory agency has announced that it will make drug safety information, which has long been kept confidential, available to the public. The decision comes after citizens and medical journals began pushing for a release of information on the side effects of Accutane, an acne drug that has been linked to increased risk of suicide, birth defects and bowel problems

The European Medicines Agency’s (EMA) decision follows an April 2010 finding by a European Ombudsman that the agency was not honoring transparency regulations adopted by the E.U. in 2001. The EMA argued that some drug safety information would be misleading to the general public and cause undo alarm.

The question of what drug side effect information the EMA should release came to a head following requests by Liam Grant, who sought information after his son committed suicide in 1997 while on Accutane. The EMA refused the request for information about other Accutane problems, indicating that the E.U.’s transparency laws did not apply to serious adverse event reports for drugs.

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Grant has a filed an Accutane lawsuit against Roche, the drug’s manufacturer, and hopes that access to the files will make his case stronger.

Grant took his case to European Ombudsman Nikiforos Diamandouros, who sided with Grant and determined that EU transparency rules applied to all of the EMA’s documents, although there may be some exceptions. Diamandouros recommended that EMA review its decision, and suggested that EMA provide additional context along with documents it thought might be misleading if released.

In the United States, nearly 1,000 product liability lawsuits over Accutane have been filed by individuals who allege that the manufacturers of the drug failed to adequately warn about potential side effects experienced by users, which can include an increased risk of birth defects, suicide and serious bowel problems from Accutane. The company has lost all six Accutane bowel disease trials that have reached a jury so far, with verdicts totalling $56 million. One of those judgments has been overturned on appeal and will likely face a retrial.


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