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FDA pulls Avandia off retail pharmacy shelves

It’s official: Avandia will no longer be found on most US pharmacy shelves starting 18 November. After deciding last autumn to severely limit the use of GlaxoSmithKline’s beleaguered type 2 diabetes drug, the US Food and Drug Administration outlined new restrictions this week that will make the drug available only through a special mail-order program to diabetics whose blood sugar levels are not controlled by other drugs.

This decision follows a number of studies showing that Avandia (rosiglitazone) triggers more heart attacks than its competitor, Takeda’s Actos (pioglitazone). The European Medicines Agency suspended Avandia last year, forcing diabetics to find other medications to control their blood sugar levels.

“It’s like a decade-long nightmare coming to an end,” Steven Nissen, chief of cardiovascular medicine at the Cleveland Clinic, told USA Today. “Eleven years after this drug was introduced, it will be so restricted in access that virtually no one will be able to get it.”

Some people might be reluctant to give up Avandia, but, fortunately, alternative options abound. According to a meta-analysis out this week in the Annals of Internal Medicine, all other available diabetes drugs are just as effective when used to control blood sugar levels with two other conventional medicines. In the review of 18 clinical trials totaling around 4,500 participants, researchers from the Federal University of Rio Grande do Sul in Portugal found little difference in benefit between the thiazolidinediones (which include Avandia and Actos), alpha-glucosidase inhibitors (such as Bayer’s Precose), glucagon-like peptide-1 agonists (including Byetta’s Exenatide and Novo Nordisk’s Victoza) and dipeptidyl peptidase-4 inhibitors (which include Merck’s Januvia and Bristol-Myers Squibb’s Onglyza).


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