Editorial Criticizes EMA Refusal to Release Reports of Problems with Accutane

An editorial in a leading medical journal has criticized the European Medicines Agency (EMA) for refusing to release adverse event reports detailing potentially serious problems with Accutane, an acne drug that has been linked to a number of side effects, calling for more transparency in the agency. 

The EMA should increase their openness on licensing decisions and suspected adverse reactions to improve the public’s trust in the agency, according to the editorial published last month in The Lancet. Such a move would mirror recent actions by the FDA in the United States to provide increased public access to information about potential health risks associated with medications.

The Lancet editorial highlights the EMA’s refusal to release reports of Accutane adverse events that were requested by Liam Grant, who requested the information after his son committed suicide on Accutane in 1997. The EMA refused the request for information about other Accutane problems, indicating that the European Union’s transparency laws did not apply to serious adverse event reports for drugs. The EMA argued that the documents could be misinterpreted and mislead EU citizens.

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.

The EMA will respond to the recommendations by July 31, 2010.

“Citizens of EU member states should welcome and support transparency initiatives within EMA, which might bring about more openness on licensing decisions and suspected adverse reactions,” The Lancet editorial states. “Since EMA plays an important part in the supervision and approval of medicines in the EU market for the benefit of public health, it should consider providing the widest possible public access to the requested reports in any form…and pursue a proactive information policy for the public.”

In the United States, nearly 1,000 Accutane lawsuits 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.

Last month, a study published in the American Journal of Gastroenterology found that Accutane side effects quadruple the risk of ulcerative colitis. Researchers found that not only were those taking Accutane four times more likely to develop ulcerative colitis, but they also determined that the chance of developing the bowel disorder rose in relation to the size of the Accutane dose, strengthening the evidence of a causal relationship.