A black box warning, or boxed warning, is the strongest warning the FDA can issue and is given to prescription drugs that may cause serious or life threatening health consequences. The boxed warning section describes the risk for congestive heart failure and myocardial infraction, or heart attack, as statistically significant based on clinical trials.

Also added to the warnings and precautions section of the safety information for rosiglitazone are warnings for cardiac failure, adverse cardiovascular events, and fractures. The adverse reactions section was also updated to include a possible increased risk for heart attack when Avandia is used in combination with insulin.

Last fall, the FDA voted to put tight restrictions on Avandia and other drugs in its class based on data from clinical trials that showed use of the drug put patients at risk for cardiovascular events such as heart attacks and strokes. The FDA also ordered makers of the drug to update the product’s safety label to include the warnings. Since the FDA’s ruling, in order for Americans to continue to receive the drug, their doctors must attest to and document their patients’ eligibility. Patients will also have to review statements describing the cardiovascular safety concerns associated with Avandia and acknowledge they understand the risks.

SOURCE: Avandia Recall › FDA approves new warnings on Avandia packaging

GSK was facing about 2,000 lawsuits alleging it covered up Avandia’s heart attack and stroke risks. The company previously agreed to pay about $460 million to resolve allegations it didn’t properly warn doctors and consumers about the medicine’s risk. That news brought more lawsuits against the GSK, and more settlements to the forefront.

The drug was pulled from the European market and severely restricted in the United States last September, after studies linked Avandia to an increased risk for cardiovascular events. This week, the Food and Drug Administration (FDA) approved label changes for Avandia and outlined the standards that patients must meet before they can take the drug.

Those guidelines state that the drug should only be used in patients already being treated with rosiglitazone, in patients whose blood sugar cannot be controlled with other anti-diabetic medications, and who, after consulting with their health care professional, do not wish to use pioglitazone-containing medications, another type of diabetes drug that includes the brands Actos, Actoplus Met, Actoplus Met XR, or Duetact.

Avandia is a single-ingredient product and is also sold as a combination product under the brand name Avandament (with metformin) and the brand name Avandaryl (with glimepride).

Studies suggest as many as 100,000 heart attacks may have been caused by the drug.

SOURCE: Avandia Recall › GSK pays out more money to settle lawsuits against deadly diabetes drug

According to the FDA’s announcement, the “FDA previously communicated to the public about the possible association between rosiglitazone and increased cardiovascular risk in a 2007 safety alert. The agency also sought advice from external experts at the July 30, 2007, joint meeting of the FDA Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees. The RECORD study data represent the only new information from a completed randomized, controlled clinical trial of rosiglitazone received by FDA since the 2007 announcements.”

The RECORD study, which stands for Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes, was designed to evaluate the cardiovascular safety of rosiglitazone. This practice is consistent with the FDA’s December 2008 Guidance for Industry that recommends that manufacturers of new treatments for diabetes carefully design their clinical trials to include an evaluation of cardiovascular safety.

Once the FDA has completed its review of rosiglitazone, the agency will present its findings at a joint public meeting of the Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees in July 2010.

Rosiglitazone, a treatment for Type 2 diabetes, is sold as a single-ingredient product under the brand name Avandia, and is available in combination with other diabetes medications, such as metformin, under the brand name Avandament, or glimepride, under the brand name Avandaryl. The FDA advises that patients who are currently taking any form of rosiglitazone should not stop taking their medication without first talking to their healthcare professional. Any side effects with this or any other medication should be reported to the FDA MedWatch Adverse Event Reporting program at www.fda.gov/medwatch.

SOURCE: Avandia Recall › FDA announces it will review studies linking Avandia to heart attacks