October 8, 2010
As requested by FDA, Abbott Laboratories is withdrawing a weight loss drug Meridia from the market.
The FDA states that the drug that was approved in 1997 raises the heart attack and stroke risks.
An FDA expert advisory panel split in an eight to eight vote that took place in September on whether Meridia should stay on the market.
Director of FDA's drug evaluation branch, John Jenkins, MD, said that the drug had an unjustifiable availability on the market when comparing a very modest weight loss that people achieve to their risk of heart attack or stroke.
The patients in possession of the drug are advised to discard any remaining pills and consult their doctor in relation to alternative weight-loss programs.
The FDA's evaluation of Meridia was strongly criticized by Abbott, but it says that it will comply with the FDA's request.
In a news release the company said that the drug has a positive risk/benefit profile, but the company is going to comply with the request.
Heart Attack and Stroke Risks
At the time when the drug was considered for approval, the concerns about Meridia were raised. The drug was linked to increased heart rate and blood pressure. But because loosing weight was supposed to reduce this risk, it was believed that the benefits of the drug would more than make up for the risks.
But European drug regulators insisted that the company carry out a postmarketing clinical trial in order to evaluate heart risk. Overweight and obese patients with risk factors for serious heart disease were enrolled in the trial called SCOUT. The majority of these patients would not be prescribed the drug in the United States. But the company believed that the study will show that even these patients can benefit from the drug.
But the drug increased the risk of heart attack and stroke in the SCOUT patients. Director of FDA's drug evaluation branch said that it was a very important new information. When the study was reviewed, they realized that all patients using the drug were at the risk of suffering from heart attack and stroke, even though in any individual patient the risk was very small.
The FDA advises the patients who are now taking Meridia to stop taking it and talk to the health care professional about alternative weight-loss programs. Patients who have concerns about Meridia must talk to a health care professional. If a person experiences a pain in the chest, abnormal heart rate or rhythm, palpitations or other symptoms including dizziness and lightheadedness, he needs to contact a health care professional immediately. Any side effects must be reported to FDA's MedWatch program.
An unused Meridia must be disposed by following the recommendations outlined in the Federal Drug Disposal Guidelines, namely: