F.D.A. to Heavily Restrict the Diabetes Drug Avandia
*** Avandia® Labeling Update 2/4/11: The FDA has notified healthcare professionals and patients that information on the cardiovascular risks (including heart attack) of Avandia (rosiglitazone) has been added to the physician labeling and patient Medication Guide. Additionally, the drug labels have been revised to state that rosiglitazone and rosiglitazone-containing medicines should only be used:
- In patients already being treated with these medicines
- In patients whose blood sugar cannot be controlled with other anti-diabetic medicines and who, after consulting with their healthcare professional, do not wish to use pioglitazone-containing medicines (Actos, Actoplus Met, Actoplus Met XR, or Duetact).
What’s the problem?
September 23, 2010 – This week, drug regulators in Europe and the United States announced that Avandia will soon no longer be widely available. In fact, patients in the United States will be allowed access to the medicine only if they and their doctors attest that they have tried every other diabetes medicine and that patients have been made aware of the drug’s substantial risks to the heart.
Also this week, the F.D.A. ordered Avandia manufacturer GlaxoSmithKline (GSK) to conduct an independent assessment of the Record trial, a landmark study of Avandia’s heart effects that an F.D.A. medical officer found was riddled with what he said were unpardonable errors that seriously biased the trial’s conclusions.
Senate investigators found that GlaxoSmithKline spent years hiding from regulatory authorities clear indications that Avandia increased heart risks. In July, GSK took a $2.3 billion liability charge related to legal cases involving Avandia and another medicine, Paxil.