FDA Limits Access to Avandia
If you’ve stopped by our blog here lately, you may have seen frequent updates on the diabetes drug Avandia. The drug has been in the news lately due to a heightened risk of the cardiovascular system in patients. Today, two regulatory entities, the European Medicines Agency and the US Food and Drug Administration, have announced what they will do about the availability of Avandia in their respected countries.
The European Medicines Agency is recommending the suspension of Avandia. New prescriptions will not be made and the EMA is advising patients to see their doctors about moving to an alternate medicine. Read the full press release from the EMA here. The suspension of Avandia will remain until drug maker, GlaxoSmithKline, can prove with convincing data that the benefits outweigh the risks in a group of patients.
The US Food and Drug Administration announced that the drug will stay on the market, but only with significant restrictions in the United States. Those who are currently taking the drug may continue to take it, but only after they sign-off on knowing the risk they are taking in continuing use of the drug. For patients who have not been taking Avandia, a doctor will have to certify that blood sugar levels could not be controlled by other medications and that there are medical reasons they cannot take Avandia competitor, Actos.
Quotes on today’s announcements:
The FDA is taking this action today to protect patients, after a careful effort to weigh benefits and risks.We are seeking to strike the right balance to support clinical care.”
– FDA Commissioner Dr. Margaret A. Hamburg
Hamburg Says Avandia Restricted to `Limited Conditions’: Video
Major crackdown on GSK’s Avandia
Doctors React to Avandia Decision
FDA Restricts Use of Diabetes Drug Avandia
FDA Restricts Access to Avandia
Quick History of What We’ve Covered on the Blog:
February 2010 Senate Report
Study released by the Journal of the American Medical Association
Day 1 of the FDA Panel Meetings
Day 2 of the FDA Panel Meetings
Panel Meeting Wrap Up
Related Video (FDA Panel Meeting on Avandia)