Abbott withdraws anti-obesity drug amid safety worries
pharmafile | October 11, 2010 | News story | Sales and Marketing | Abbott, Meridia, obesity
Abbott has pulled its anti-obesity drug Meridia in the US after recent trials showed it increased the risk of stroke and heart attack in patients with heart disease.
The withdrawal of Meridia follows an 11-month process, beginning in November 2009, when Abbott notified FDA of preliminary results from the SCOUT trial.
Published in the New England Journal of Medicine last month, the trial showed patients with heart disease taking the drug had a 16% increased risk of heart attacks and stroke compared to those given placebo.
After these data were released, the FDA asked the US-based pharma firm to pull the drug.
John Jenkins, director of the office of new drugs in the FDA’s center for drug evaluation and research, said: “Meridia’s continued availability is not justified when you compare the very modest weight loss that people achieve on this drug to their risk of heart attack or stroke.
“Physicians are advised to stop prescribing Meridia to their patients and patients should stop taking this medication. Patients should talk to their health care provider about alternative weight loss and weight loss maintenance programmes.”
The EMA withdrew the drug back in January due to similar concerns over its side effects.
The FDA approved Meridia in 1997 for weight loss and maintenance of weight loss in obese people, as well as in certain overweight people with other risks for heart disease.
The approval was based on clinical data showing that more people lost at least 5% of their body weight when given Meridia than those on placebo who relied on diet and exercise alone.
Abbott believes Meridia still has a positive risk/benefit profile in the approved patient population, but says it will comply with the FDA’s request.
Ben Adams
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