Under the terms of a landmark joint action announced last week by both the U.S. Food and Drug Administration (FDA) and the European Union’s European Medicine Agency (EMA), the availability of the diabetes drug Avandia will be limited or non-existent going forward.  Citing studies linking Avandia to increased risk for heart attacks and strokes, EMA authorities said sales will be prohibited, while the FDA will permit patients in the United States access under limited circumstances.

Avandia is used to treat Type 2 diabetes by increasing the body’s sensitivity to insulin. It continues to be widely available outside the U.S. and E.U.

One study conducted between 1999 and 2009 linked Avandia to 47,000 “unnecessary” cases of stroke, heart attack and heart disease.  The FDA’s authority to restrict the use of Avandia comes as a result of a law passed in 2007 that gives the agency new powers over drug makers and drug distributors. 

Although it is not clear why EMA officials in Europe banned the drug, there is speculation that authorities believe that a similar drug, Actos — shown in preliminary studies to demonstrate fewer heart attacks and less heart failure — is a suitable alternative.  The FDA appears less quick to judge.  Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research and the author of the FDA statement, said “It is difficult to draw definite conclusions from the studies (done on Avandia and Actos), both because of the small size of the observed effects, and because it is not clear whether the findings, if valid, represent beneficial effects of Actos or toxicities of Avandia.”

In the meantime, diabetics who are currently taking Avandia and planning on traveling outside of the United States should ask their physicians about switching to Actos.  If that is not possible, visitors to Europe should make sure they have enough Avandia on hand to last the trip, as obtaining a prescription in Europe is no longer possible.

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About The Author

Frank Gillingham, M.D. serves as Chief Medical Director for HTH Worldwide. Frank has led HTH Worldwide's international business development efforts in Europe and Canada and has been a guest speaker at international business conferences and has authored a series of articles on travel medicine, including pieces on travel information available on the Internet and the role of physicians working with travel insurers. Frank is a Board-Certified Internist and Emergency Medicine Specialist. He is also a private emergency physician in Southern California and a former emergency department director and member of the UCLA emergency department staff. Frank completed residency training at Los Angeles County/USC Medical Center, received his M.D. from Albert Einstein College of Medicine and his B.A. from the University of Pennsylvania .

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