Should I Be Taking Avandamet?
I keep seeing warnings about the drug Avandia. I am currently taking Avandamet, a combination of Avandia and metformin. I had a heart attack in 1998 and was diagnosed with diabetes five years later. An endocrinologist put me on Avandamet, which I have taken ever since. Should I be concerned? Douglas W. Rust, Elyria, Ohio
Craig Williams, PharmD, responds:
Patients and doctors are still confused about the implications of the Food and Drug Administration's ruling in September 2010 on taking rosiglitazone (Avandia, Avandaryl, and Avandamet). The FDA ruling laid the groundwork for a new restricted access program for the medication. But that program has not been implemented as of this writing, and questions remain about what exactly it will look like. Here are a few things that we know:
- The program will apply to all forms of rosiglitazone. Avandia is rosiglitazone by itself, Avandamet is the drug in combination with metformin, and Avandaryl is a combination with glimepiride.
- The restricted access will apply to new and existing users of the drug, but the provisions will probably first be applied to potential new users.
- Rosiglitazone will not be removed from the U.S. market, and it will be possible for people to remain on these medications if the patient and the prescriber are committed to doing so.
To stay on rosiglitazone, patients will need to show that they understand the cardiac risks that now appear to be associated with the drug. This will most likely involve signing a disclosure statement, which will be used to register a patient for the restricted access program. The doctor prescribing rosiglitazone will also have to state his or her willingness to continue prescribing the drug, and indicate that the patient cannot take all other forms of glucose-lowering drugs including Actos, the other medication in the same class as rosiglitazone. While the new program is expected to drastically reduce the use of Avandia, Avandamet, and Avandaryl, it will be possible to stay on those drugs if you and your provider feel this is right for you.
Not everyone agrees with the FDA's decision, and in the end it largely came down to the fact that Actos is just as effective as Avandia in most people and appears not to have the same safety concerns. Ask your doctor if you should try taking Actos instead. For more information, visit fda.gov and search for "Avandia."