Jan. 22, 2010 -- THURSDAY, Jan. 21 (HealthDay News) -- The weight-loss pill Meridia should not be used by people with a history of heart problems because the drug can increase the risk of heart attack and stroke in such people, U.S. drug regulators said Thursday.
The U.S. Food and Drug Administration said the drug's manufacturer, Abbott Laboratories, has agreed to revise Meridia's label to add the new warning.
Specifically, the drug should not be used by people with a history of coronary artery disease (e.g., heart attack, angina), stroke or transient ischemic attack, heart arrhythmias, congestive heart failure, peripheral arterial disease, or uncontrolled high blood pressure, the agency said.
Patients taking Meridia (sibutramine) should talk with their doctor to see if continued use of the drug is safe, the FDA said.
Abbott had previously stressed that the drug is only approved for patients with no history of heart disease.
The FDA said the new warnings were 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, compared with patients taking a placebo. Patients in the study were older than 55 and overweight or obese with a history of heart disease or diabetes.
The consumer advocacy group Public Citizen asked the FDA to take Meridia off the market late last year, contending there had been a total of 84 deaths associated with the drug reported to FDA as of last June, the Associated Press reported.
The FDA approved Meridia in 1997 as a weight-loss aid to be used in combination with diet and exercise. The drug is related to the amphetamine family of stimulants, the news service said.
To learn more, visit the U.S. Food and Drug Administration.
SOURCES: U.S. Food and Drug Administration, news release, Jan. 21, 2010; Associated Press