Rosiglitazone, the generic name for the Type 2 diabetes drug Avandia, long the focus of discussion by the medical community, is again making headlines. And the information is somewhat confusing for patients or caregivers.
This past June, the FDA, in what the New York Times called "a highly unusual move," asked a panel of experts to determine if the agency should reconsider restrictions on the drug.
A few weeks ago, the panel in a mixed vote agreed to amend and lessen the strict prescribing rules on Avandia, reported Forbes. The article cautioned, "But the vote should not be interpreted as a broad statement by the panel that rosiglitazone is safe. Panel members made clear that they still had concerns about the safety of the drug. But their concerns were less pressing than in the past."
Beyond a Warning Label. Since 2011, the Food and Drug Administration dictated prescribers must enroll in a "Risk Evaluation and Mitigation Strategy" as studies showed that diabetic patients (taking Avandia) with coronary artery disease had an increased risk of death from a major cardiac event.
Many patients switched to other drugs.
Physicians were advised that patients being successfully treated on Avandia as well as newly-diagnosed Type 2 diabetics whose blood sugar could not be controlled by other medications could stay on the therapy. Filled prescriptions for Avandia dropped by half. Patients determined by their physicians to meet the criteria could only get Avandia through the mail from a participating, certified pharmacy.
Muddying the Waters. An update from information reported at the 2010 American Diabetes Association meeting, has been expanded in a post-hoc review by Richard Bach, M.D. of Washington University and his colleagues. (A post-hoc analysis looks at trends and patterns in data after the experiment is completed.)
According to Diabetes In Control, an on-line site for medical professionals, this new information corroborates what Avandia's drug-maker Glaxo-Smith-Kline found in a re-analysis of their own data, that "rosiglitazone didn't increase the risk of a composite of cardiovascular death, myocardial infarction and stroke."
What Does This Mean For You? If you are a Type 2 diabetic, or you love and care for a Type 2 diabetic, managing medication is an important part of total care. If you are taking Avandia and have concerns, talk with your doctor.
All label changes are routinely reported to all medical prescribers, whether you go to a nurse practioner or a cardiologist. Don't be afraid to ask questions. It's not a bad idea to write them down before you get into the exam room.
Aside from talking with your physician, the next best thing you can do is stick to an appropriate health routine, take and record your blood sugar, eat a healthy well-balanced diet, manage your stress level, and get regular exercise.