My Clinical Trials Diary

FDA Decides Not to Ban Avandia, but Puts Restrictions on How It’s Used. By Daniel J. DeNoon WebMD Health News Sept. 23, 2010 -- The FDA will not ban Avandia -- but stringent restrictions will make it far harder for doctors to prescribe the safety-troubled diabetes drug. The European Medicines Agency took harsher action. European sales of Avandia-containing drugs will be suspended over the next few months, although the agency did not formally withdraw approval. The 600,000 U.S. patients currently taking Avandia can continue to take the drug only if their doctors officially attest that their patients understand the risks, that the drug is helping them, and that no other diabetes drug can keep their blood sugar under control. New Avandia prescriptions can only be written for patients who, for medical reasons, cannot take Actos . Actos, a diabetes medication in the same class as Avandia, does not cause the heart problems linked to Avandia. "Avandia will be ava...

GSK adds CHF boxed warning on Avandia label Friday, August 17, 2007 10:00 IST  Philadelphia, Pennsylvania GlaxoSmithKline announced that the US Food and Drug Administration (FDA) has approved updated US prescribing information for the thiazolidinediones (TZD) class of medicines used in the treatment of type 2 diabetes. This approval allows GSK to implement changes in the label for Avandia (rosiglitazone maleate) as previously committed.  The label will contain a boxed warning, which increases the prominence of an already existing warning for all medicines in the TZD class on the risk of congestive heart failure (CHF), a well known and well characterized risk in this class of medicine. The boxed warning also will note that TZDs are not recommended in patients with symptomatic heart failure, and that initiation of TZDs in patients with established NYHA class III or IV heart failure is contraindicated.  The contraindications have also been updated regarding initiation of Avandia in patien...