FDA panel recommends easing Avandia restrictions

American Heart Association Comment

DALLAS, June 6, 2013 – 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.

“Those voting to modify current restrictions may believe that it would enable researchers to more definitively assess the potential risk for heart attack and other major heart events with this drug,” saidAmerican Heart Association national spokesperson Jorge Plutzky, M.D. “Many panelists expressed the need for more data, which would be difficult to obtain under the current level of restriction.”

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.

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The American Heart Association/American Stroke Association receives funding mostly from individuals. Foundations and corporations donate as well, and fund specific programs and events. Strict policies are enforced to prevent these relationships from influencing the association’s science content. Financial information for the American Heart Association, including a list of contributions from pharmaceutical companies and device manufacturers, is available at www.heart.org/corporatefunding.

Related links:

2010 AHA/ACC issue advisory on diabetes drugs and heart risk: http://www.newsroom.heart.org/index.php?s=43&item=970

2010 Aspirin for Primary Prevention of Cardiovascular Events in People With Diabetes, A Position Statement of the American Diabetes Association, a Scientific Statement of the American Heart Association, and an Expert Consensus Document of the American College of Cardiology Foundation http://circ.ahajournals.org/cgi/content/full/121/24/2694

Sept. 2010 media comment on FDA restrictions to rosiglitazone: http://newsroom.heart.org/news/1125

2007 Statement from the American College of Cardiology, American Diabetes Association and American Heart Association Related to NEJM article, “Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes”  http://americanheart.mediaroom.com/index.php?s=43&item=61

For Media:  AHA Communications (214) 706-1173


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