Safety restrictions added to Avandia

[cougarnurse]

FYI: http://news.yahoo.com/s/ap/20110207/...g_restrictions

GlaxoSmithKline PLC said Monday it has updated the labeling of its diabetes pill Avandia to include safety restrictions ordered by federal health authorities because of the drug's links to heart attack.

The Food and Drug Administration announced the changes in September as the last in a series of safety actions against the former blockbuster drug, which has triggered thousands of patient lawsuits and a Department of Justice investigation. The European Union has banned the drug.

The new U.S. label indicates that Avandia is only intended for patients who cannot control their blood sugar with any of the other diabetes medications on the market. Patients who are currently on the drug can continue taking it after consulting with their doctor.

While there are more than a dozen diabetes drugs on the market, only Actos from Japan-based Takeda Pharmaceuticals works the same way as Avandia. U.S sales of Actos have risen steadily — hitting $3.4 billion in 2009 — as Avandia's reputation has soured.

The FDA first approved Avandia in 1999 and it became the top-selling diabetes pill in the world, with more than $3 billion in sales by 2006. But use has plummeted since a 2007 analysis first linked the drug to heart attack.

Determining Avandia's heart risk was a painstaking process that dragged on for years because most patients taking the drug are already predisposed to heart problems due to diabetes.

More than 900,000 U.S. patients filled prescriptions for Avandia in the first half of 2010, according to health data firm IMS Health. That number is expected to shrink as the new FDA restrictions go into place.

London-based Glaxo reported late last year that the Justice Department and several state attorneys general are investigating the development and marketing of Avandia. A Senate investigation released last year concluded that Glaxo knew about the risks of its drug years before they were made public and withheld important data from the FDA.

The company has reportedly settled thousands of personal injury lawsuits filed by Avandia patients, though Glaxo executives say a number of additional lawsuits have been filed since the FDA's announcement last year. They have not specified the number.

[cougarnurse]

Another story on this subject: http://www.modernmedicine.com/modern...d=40126&ref=25

FDA has announced that the physician labeling and patient medication guide for rosiglitazone (Avandia, GlaxoSmithKline) have been changed to include information on cardiovascular risks (including death) of this agent.

In addition, labeling has been revised to state that rosiglitazone and rosiglitazone-containing medications should only be used in patients already being treated with these agents, or in patients whose serum glucose levels cannot be controlled with other anti-diabetic medicines and who, after consulting with their healthcare provider, do not wish to use pioglitazone-containing medicines (Actos, Actoplus Met, Actoplus Met XR, or Duetact). Rosiglitazone is also sold as a combination product under the brand name Avandamet (rosiglitazone and metformin) and under the brand name Avandaryl (rosiglitazone and glimepiride).

In late September 2010, FDA announced that it would significantly restrict the use of rosiglitazone-containing medicines to patients with type 2 diabetes who cannot control their serum glucose levels with other medications. These new restrictions came about as a response to data that suggested an elevated risk of myocardial infarction in patients treated with rosiglitazone.

The Risk Evaluation and Mitigation Strategy (REMS) that will restrict the availability of medications containing rosiglitazone has not yet been approved or formally implemented. FDA expects to approve the REMS by spring 2011, and the manufacturer to complete implementation 6 months thereafter.