The treatment of diabetes 2 took a hit today, but one that will prevent a higher risk of heart attack in patients and thus potentially save lives in the long run. The FDA will pull GlaxoSmithKline’s lucrative rosiglitazone (Avandia) off pharmacy shelves November 18, 2011. Instead, physicians wishing to prescribe the type 2 diabetes drug will have to enroll their patients in a special registry now and the drug will be dispensed through mail order to patients on the registry from specially certified pharmacies.
Rosigilitazone is also marketed as a combination drug containing other anti-diabetic medications under the names Avandamet and Avandaryl to patients who are already being successfully treated with it. The new action, implemented under the agency’s Risk Evaluation and Mitigation Strategy, applies not only to Avandia, but also to Avandamet (which contains rosiglitazone and metformin) and Avandaryl (a combination of rosiglitazone and glimepiride).
At any rate, the use of rosiglitazone dropped steadily in 2010, according to FDA. From January 2010 through October 2010, around 460,500 patients filled a prescription for a rosiglitazone product from outpatient retail pharmacies. The projected number of patients filling a prescription for a rosiglitazone-containing product declined by 50% during that time, from 235,500 patients in January 2010 to around 119,000 in October 2010.
The drug was known to worsen congestive heart failure (condition in which the heart is unable to pump enough blood to the other parts of the body), and that taking rosiglitazone may increase the risk that a patient would experience a heart attack.
The risk was higher if one took insulin along with rosiglitazone. Side effects and increased symptoms included: shortness of breath; pain in the jaw, arm, back, neck, or stomach; pain in the center of the chest that lasts for a more than a few minutes or that goes away and comes back; uncomfortable pressure, fullness, or squeezing in the chest; breaking out in a cold sweat; nausea or vomiting; or lightheadedness.
Earlier this year, the FDA notified healthcare professionals and patients that information on the cardiovascular risks (including heart attack) of rosiglitazone has been added to the physician labeling and patient Medication Guide. This information was first announced by FDA on September 23, 2010 as part of new restrictions for prescribing and use of this drug.
Avandia is in a class of drugs known as thiazolidinediones, or TZDs. It is intended to be used in conjunction with diet and exercise to improve glucose (blood sugar) control in patients with Type 2 diabetes mellitus. As mentioned earlier, rosiglitazone also is available in combination with other diabetes medications, metformin under the brand name Avandamet or glimepiride under the brand name Avandaryl.
The blockbuster drug was introduced by GlaxoSmithKline in 1999 and soon became one of the most popular diabetes drugs because of its ability to improve control of Type 2 diabetes. By 2006, at least 1 million Americans were taking the drug and annual sales had climbed to more than $3 billion.
Researchers at the Duke Clinical Research Institute (DCRI) reported in the American Heart Journal (June 2013) that patients on Avandia do not have a higher heart attack risk than those on metformin/sulfonylurea. The DCRI team re-assessed the original findings of RECORD.
Written by Sy Kraft