Friday & Cox LLC
Search
Call Us Today for a Free Consultation: 412-668-4491
Email us for a free consultation Calls answered 24 hours a day
View our practice areas

FDA Overturns Safety Limits on Diabetes Drug Avandia

The FDA recently overturned safety limits that restricted the sale of the diabetes drug Avandia (rosiglitazone).  The drug, manufacturered by GlaxoSmithKline had been much debated over the past several years due research done in 2007, which suggested that use of the drug was linked to a higher risk of heart attack.  The FDA limited the sale of the drug in response to the research findings in 2010 that suggested it use might be dangerous.  Now the drug is being unrestricted meaning that those suffering from diabetes will not have to enroll in a special program to obtain the drug.  This recent action by the FDA is not without controversy however, since no new informaton concerning the drug has been made available since the original decision was made.  Additionally, the doctor at the head of the 2007 study, which resulted in the FDA's safety restrictions is questioning the motives of the FDA. 

The FDA said that its decision is in line with advice it has received from expert advisory committees.  Prior to lifting the safety restrictions the FDA hired Duke University to revisit the 2007 study.  The results from Duke's research matched that of the drug maker's--that use of the drug does not appear to increase the risk of heart attack.

Interestingly in 2012, Glaxo pled guilty for failing to report safety complications of Avanda to government officials.   

Sources: 

AP, "FDA Overturns safety limits on diabetes drug," by Matthew Perrone, November 25, 2013.

Forbes. com, "FDA removes restrictions on Avandia," by Larry Husten, November 25, 2013.

No Comments

Leave a comment
Comment Information
Email us for a response

How Can We Help You?

Bold labels are required.

Contact Information
disclaimer.

The use of the Internet or this form for communication with the firm or any individual member of the firm does not establish an attorney-client relationship. Confidential or time-sensitive information should not be sent through this form.

close

Privacy Policy

Office Locations

Friday & Cox LLC
1405 McFarland Road
Pittsburgh, PA 15216

Phone: 412-668-4491
Fax: 412-561-4291
Pittsburgh law office map

Friday & Cox LLC
Phones Answered 24 Hours A Day