Abbott’s Meridia ‘increases heart attack risk’
pharmafile | September 2, 2010 | News story | Sales and Marketing | Abbott, Meridia, drug safety
Abbott’s weight-loss drug Meridia increases the risk of stroke and heart attack in patients with heart disease, according a study published in the New England Journal of Medicine.
The study, funded by Abbott, has renewed calls for consumer groups in the US to have the drug pulled from the market.
The findings come two weeks before an FDA public hearing on whether Meridia should be pulled. In Europe regulators have already withdrawn the drug due concerns over its side effects.
The SCOUT trial showed that patients with heart disease taking the drug had a 16% increased risk of heart attacks and stroke compared to those taking placebo.
There was no increased risk of mortality but the trial did show that patients suffered from higher blood pressure as a result of the drug. The NEJM article did point out that patients taking Meridia lost an average of 9.4 pounds during the study.
The trial looked at 10,744 overweight or obese patients who were at least 55 years old and had either heart disease or diabetes, or both conditions, and ran from 2003 to March 2009.
Abbott expects the drug to make just £100 million this year and wants to keep it on the market for selected patients – namely the ones without heart disease.
A spokesman for Abbott told Reuters: “If you look at all of the data involved, in the approved patient population, there is certainly a positive risk-benefit profile.
“This is an important option for patients and physicians to treat a serious condition for which there are few treatments currently available,” the spokesman added.
Meridia is a central nervous system drug that works via a physiological suppression of appetite.
Its rival treatment, Roche’s prescription weight-loss drug Xenical (orlistat), is a gastrointestinal drug that works by impairing absorption of fat. A lower-dose OTC version of the drug is marketed by GlaxoSmithKline under the brand name Alli.
This will not be the first time a centrally acting suppressant has come under fire from regulators.
Sanofi-Aventis’s Acomplia (rimonabant) had its marketing authorisation suspended by the CHMP when its benefits were not deemed to outweigh the risks of ‘psychiatric adverse effects’.
Ben Adams
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