Recognizing the heart risks Avandia poses to those who use it, the Food and Drug Administration announced new rules in May to pull the diabetes drug from the shelves of retail pharmacies throughout Tennessee and the rest of the U.S.
Although the new rules don’t go into effect until November, many pharmacies have already stopped dispensing the controversial drug. Linked to severe cardiovascular events, including heart attack, congestive heart failure, stroke and liver problems, the FDA has determined that in the majority of cases, the risks of Avandia far outweigh its benefits for those living with Type 2 diabetes.
The FDA’s decision to pull Avandia comes 8 months after implementing restrictions on use of the drug to only those patients who were unable to control their Type 2 diabetes with another drug. According to Dr. Steven Nissen of the Cleveland Clinic, the move to pull the drug completely by the FDA is long overdue. A 2007 study he conducted revealed that adult-onset diabetes patients who use Avandia were 40 percent more likely to suffer from a heart attack.
Avandia Availability is Limited, But It Is Not Gone
The FDA carved out a few exceptions as to who may use Avandia to control Type 2 diabetes. Despite now being recognized as a dangerous drug, Avandia is still available to those who’ve:
- Used the drug safely in the past,
- Attempted to treat their diabetes with another drug but the drug was ineffective, or
- Discussed the potential risks of Avandia with their health care provider and choose to take the drug anyway.
Patients wishing to continue using Avandia and who fall into one of the above categories must also enroll in the Avandia-Rosiglitazone Medicines Access Program. The diabetes drug will then be available via mail order from participating pharmacies.
Avandia is the brand name for rosiglitazone, which is also sold as Avandaryl and Avandament. The diabetes drug is produced by GlaxoSmithKline. Actos, manufactured by Takeda Pharmaceuticals, is another drug widely-used to treat diabetes. It has not been shown to have similar cardiovascular risks.
Source: US News, “FDA to Pull Diabetes Drug Avandia From Pharmacy Shelves”