FDA panel recommends easing Avandia restrictions
After two days of hearings, an advisory committee to the U.S. Food and Drug Administration (FDA) voted to ease existing restrictions for the diabetes drug rosiglitazone (brand name, Avandia).
The FDA restrictions, referred to as Risk Evaluation and Mitigation Strategies (REMS), require healthcare providers to be certified to prescribe the drug, and pharmacies to be certified to dispense it. Physicians must submit forms on each patient they prescribe the drug to, and patients must acknowledge that they understand the potential risk of heart attack before they can receive it. The drug was only available to new patients if other medications had failed.
The panel vote included seven for removing all restrictions, 13 for easing restrictions five for keeping the restrictions the same, and one for withdrawing the drug from the market. The FDA will consider the committee's vote before making a final decision on the drug, but is not required to follow their recommendations.
The panel's recommendations were based on a discussion of an independent re-analysis of the RECORD trial, which was requested by the FDA.
The panel meetings were called due to "the public interest in Avandia, the extensive history of the product, and the continued uncertainty of the risk surrounding this drug," said Janet Woodcock, M.D., Director of FDA's Center for Drug Evaluation and Research in an FDA blog.
Rosiglitazone is one of the thiazolidinediones (TZDs) class of drugs, intended to be used in conjunction with diet and exercise to improve blood sugar control in type 2 diabetes patients.
Since 2010, Avandia manufacturer GlaxoSmithKline has made rosiglitazone available on a restricted basis to new patients, as required by the FDA.
For patients with diabetes, who are at increased risk for heart disease and stroke, the American Heart Association recommends the following:
- Making healthy lifestyle choices, such as not smoking, following a healthy diet and remaining physically active.
- Achieving optimal control of their blood sugar, blood pressure and lipids (such as cholesterol and triglycerides) with lifestyle and medications when needed. Good blood sugar control, keeping HbA1c levels below 7.0, can reduce the risk of the "microvascular" complications of diabetes, such as kidney failure, painful nerve problems and decreased vision or even blindness.
- Considering with their physician whether low-dose aspirin therapy is reasonable for them to reduce the risk of a first heart attack or stroke.
For healthcare providers, the American Heart Association offers the following guidance on glucose-lowering medications in patients with type 2 diabetes:
- Metformin should generally be the first choice, particularly in obese patients. If it does not produce adequate HbA1c control, other medications can be considered, recognizing that knowledge is limited about the effect of other glucose-lowering agents on cardiovascular risk.
- If a TZD (such as pioglitazone or rosiglitazone) is considered for lowering glucose, patients should not expect it to reduce the occurrence of heart attack or stroke. The rationale for choosing a TZD should be discussed with a physician. However, patients who have successfully achieved recommended HbA1c control on a TZD may consider remaining on their medication under the FDA REMS requirements. If the treating physician and/or the patient are uncomfortable with using a TZD, another medication could be substituted.
Provided by American Heart Association
