FRIDAY, Jan. 22 (HealthDay News) -- The weight-loss pill sibutramine hydrochloride (Meridia) can increase the risk of heart attack and stroke in people with a history of heart problems and, therefore, should not be used in those patients, according to a Jan. 21 announcement by the U.S. Food and Drug Administration.
Specifically, people with a history of coronary artery disease, stroke or transient ischemic attack, heart arrhythmias, congestive heart failure, peripheral arterial disease or uncontrolled high blood pressure should not use Meridia, the FDA said. The drug's maker, Abbott Laboratories, had previously stressed that Meridia is approved only for patients without a history of heart disease. Abbott has agreed to add a new warning to the drug's label.
Furthermore, the FDA said its announcement was based on results from a 10,000-patient study of Meridia released in November. The study showed a slightly higher risk of heart-related problems in patients taking Meridia than those taking a placebo. Patients in the study were older than 55 years of age and overweight or obese and had a history of heart disease or diabetes.
"Patients currently using sibutramine should talk with their healthcare professional to determine if continued use of sibutramine is appropriate and discuss any questions they may have about their treatment," the FDA said in a statement.