Weight-loss drug Meridia too risky for people with heart problems, says FDA

If you're trying to shed pounds and have had heart problems or a stroke, add the weight loss drug Meridia (sibutramine) to the things you should avoid. The Food and Drug Administration said this week its analysis of a recent study found that the drug can increase the risk of a heart attack or stroke in people with a history of heart disease problems.

The agency said Meridia's package insert was being updated to advise that the drug not be used by people with a history of coronary artery disease, such as heart attack or angina, stroke or transient ischemic attack, heart arrhythmias, congestive heart failure, peripheral arterial disease or uncontrolled high blood pressure (levels greater than 145/90 mmHg). If you're already taking the drug, you should talk to your doctor about whether you should stop.

As we reported previously, the FDA's action was spurred by preliminary findings from a study conducted last year by Meridia's manufacturer, Abbot Pharmaceutical, that involved approximately 10,000 people, 55 or older, who were overweight and had a history of heart disease or type 2 diabetes, plus one other factor that upped their cardiovascular risk. Those who took Meridia were more likely to suffer a heart, stroke or death than those on placebo. The FDA said its analysis found that the increased risk of problems was limited to those with a history of cardiovascular disease.

This isn't the final word on Meridia. The FDA said it plans to review the full study, which Abbott is expected to submit in March, and then hold an advisory committee meeting to decide if further regulatory steps are necessary. We'll keep you up to speed on any new developments, so stay tuned.

In the meantime, we've long advised against taking weight loss drugs in general and Meridia in particular (as well as another weight-loss drug, orlistat, also known as Alli), because the benefits are marginal and the side effects can be risky. Exercise and modifying your diet are better options, but if you have a history of heart problems, you should first discuss with your doctor the appropriate strategies for you.

—Steve Mitchell, associate editor, Consumer Reports Best Buy Drugs