European Medicines Agency to review safety of GlaxoSmithKline’s diabetes drug Avandia
By APFriday, July 9, 2010
European agency to review safety of GSK’s Avandia
LONDON — The European Medicines Agency says it will review the safety of the diabetes drug Avandia following research suggesting it is linked to a higher risk of heart problems, strokes and deaths in older adults.
The agency said Friday that the review will be conducted by its Committee for Medicinal Products for Human Use when it meets from July 19 to July 22. Depending on the outcome, marketing authorization for the drug in Europe could be revoked or changed.
The U.S. Food and Drug Administration will hold hearings on Avandia on Tuesday and Wednesday.
The drug’s maker, GlaxoSmithKline, says it is confident that the drug “is an important treatment option for appropriate Type 2 diabetes patients.”
