Meridia, a popular prescription weight loss drug, could cause cardiovascular side effects in people with a history of heart disease, the Food & Drug Administration (FDA) said today. Because of this risk, the label for Meridia will now bear a contraindication that it is not to be used in such patients.

Patients not to be given Meridia include those with:

• history of coronary artery disease (e.g., heart attack, angina)
• history of stroke or transient ischemic attack (TIA)
• history of heart arrhythmias
• history of congestive heart failure
• history of peripheral arterial disease
• uncontrolled hypertension (e.g., > 145/90 mmHg)

In November, the FDA said that preliminary data from a study called Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of a Cardiovascular Event (SCOUT) suggested that patients using Meridia experienced a higher number of cardiovascular events compared to those using a placebo. SCOUT, which began in 2002, involved approximately 10,000 patients who were 55 years of age or older, overweight or obese, and had a history of heart disease or type 2 diabetes plus one additional cardiovascular risk factor. Patients who recently had a heart attack or stroke, or had poorly controlled congestive heart failure were not included in the study.

Today, the FDA said additional data from the SCOUT study reviewed by FDA indicate that the increased risk for cardiovascular events with Meridia occurred only in patients with a history of cardiovascular disease.

In December, thee consumer advocacy group Public Citizen called on the FDA to ban the active ingredient in Meridia – sibutramine – immediately. a press release announcing that it had filed its second petition with the FDA to have Meridia banned, Public Citizen said the drug has caused a significantly increased number of heart attacks, strokes, resuscitated cardiac arrests or deaths in obese patients.

Public Citizen first sought such a ban in 2002, stating that results of pre-approval clinical trials had demonstrated increases in blood pressure, pulse rate and palpitations in obese patients taking the drug.