Weight-Loss Drug Meridia Linked to Reports of Heart Complications, FDA Warns
The Food and Drug Administration said early results from a new study suggest patients taking the weight-management drug Meridia are at increased risk of suffering deadly heart attack, stroke, and cardiac arrest.
The FDA just announced its preliminary findings about an apparent link between the drug and the cardiovascular events. In the study, researchers found Meridia users were at greater risk of injury compared to patients taking inactive placebo pills.
Meridia (known generically as sibutramine hydrochloride) was approved by the FDA in 1997 for use in treating obese patients. It is a prescription drug used along with reduced-calorie diets in patients who have a body mass index (BMI) greater than 30 or a BMI of greater than 27 along with other risk factors, such as diabetes, high cholesterol, or high blood pressure, the FDA said.
Study Finds Increased Risks in Meridia Users
The study, called the Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of a Cardiovascular Event (SCOUT), began in 2002 and included about 10,000 overweight or obese patients age 55 and older. The study was designed to show that weight loss along with Meridia and standard care was more effective in reducing the number of cardiovascular events compared to weight loss from a placebo and standard care.
However, preliminary analysis of the study results suggests that patients using Meridia experienced a higher number of cardiovascular events compared to those using a placebo, the FDA said. Cardiovascular events were reported in 11.4 percent of patients using Meridia compared to 10 percent of patients using a placebo.
“This difference is higher than expected, suggesting that sibutramine is associated with an increased cardiovascular risk in the study population,” the FDA said in a statement.
Proceed With Caution on Meridia, FDA Says
The study’s findings mean the use of Meridia should be avoided in patients with a history of heart disease, congestive heart failure, stroke, or arrhythmias. The labeling on sibutramine drugs, including Meridia, already carry a warning label about these risks.
“Consumers should talk to their healthcare professional about whether sibutramine is right for them,” said the FDA statement.
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