Abbott Pharmaceuticals has announced the withdrawal of weight loss drug Meridia from shelves in the United States and urged patients to stop taking it after regulators questioned its safety. The withdrawal happened last Friday in the US. In January, Meridia sales were suspended in Europe.
These steps had to be taken after a study published in the acclaimed New England Journal of Medicine found that Meridia users had a higher risk of heart attacks and strokes. The risk of heart attacks rises by 16% said the study. The Food and Drug Administration also said that the drug was causing “modest weight loss” and the benefits did not balance out the risks.
Abbott agreed to comply with the FDA rulings but said in a statement that the company still believed Meridia's benefits outweighed its risks in approved patients. The company also said numerous studies, aside from the Scout study published in the NEJM, did not find a heightened heart risk. It said that in 46 clinical trials and 6 million patient-years of use since Meridia's approval, the company hasn't seen “the excess cardiovascular risk found in the Scout study,” which enrolled mostly patients who the label warns should not get the drug, an Abbott spokeswoman said. The company doesn't face any lawsuits in the U.S., she said.
With this withdrawal there is just one anti obesity prescription drug left that is approved for long-term use: Roche Holding AG's Xenical. An over-the-counter version called Alli is available from GlaxoSmithKline PLC.
Dr. John Jenkins, director of the FDA’s Office of new Drugs feels that continued availability of Meridia “is not justified” because of the heart disease risks. “Physicians are advised to stop prescribing Meridia to their patients, and patients should stop taking this medication. Patients should talk to their healthcare provider about alternative weight loss and weight loss maintenance programs,” Jenkins said.
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