The FDA and Avandia: Dr. Harlan Krumholz On The Need For Quicker Protection of Patients

In the summer of 2010, the diabetes drug Avandia was in the news almost daily. News studies that said Avandia increased heart risk were released. The drug was the center of attention for a FDA Advisory Panel meeting. These studies and hearings led to the FDA limiting the access and placing significant restrictions on the drug in the US. With all this being said, these restrictions were not placed on the drug the day after the hearings or the final decision to limit access. Like stated above, this all happened nearly a year ago. Prescribing requirements for Avandia stay the same today as they were before the Advisory Panel meeting in July of 2010.

Dr. Harlan Krumholz, a professor at Yale University School of Medicine, reports that the way the drug is prescribed is finally undergoing major changes (Please read Dr. Krumholz full article on

  • Prescribers will need to be certified. This will involve a training program and a signed agreement that the prescriber will register patients who will be taking the drug.
  • The drug can only be filled at certified pharmacies that have a system in place to ensure the patient is enrolled in the registry.
  • Patients must sign a form that they understand the risks associated with taking Avandia.

In addition to sharing the new systems of prescribing Avandia, Dr. Krumholz also touches on the pace of the FDA to implement this new system. He notes:

This system will be implemented over the subsequent 6 months. That’s a total of fourteen months elapsed before the way patients and doctors access Avandia (rosiglitazone), manufactured by GlaxoSmithKline, will change.

What became clear yesterday is that the system moves too slowly. If the FDA needs to act to protect patients – if that decision is made – then it should act quickly.

Dr. Krumholz makes many strong points in his article. We urge you to take a look at the full text on his blog by clicking here.