By ROB STEIN
Abbott Laboratories has withdrawn its popular weight-loss drug Meridia because it increases the risk for heart attacks and strokes, the Food and Drug Administration announced Friday.
“Meridia’s continued availability is not justified when you compare the very modest weight loss that people achieve on this drug to their risk of heart attack or stroke,” said a statement from John Jenkins, director of the FDA’s Office of New Drugs in the Center for Drug Evaluation and Research. “Physicians are advised to stop prescribing Meridia to their patients, and patients should stop taking this medication. Patients should talk to their health care provider about alternative weight loss and weight-loss maintenance programs.”
Meridia, also known as sibutramine, was approved by the FDA in November 1997 for weight loss and maintenance of weight loss in obese people, as well as in certain overweight people with other risks for heart disease. The approval was based on studies that showed that the drug could help people lose at least five percent of their body weight compared with people who took a placebo and relied on diet and exercise alone, the FDA said. The FDA requested the withdrawal after reviewing data from a study called the Sibutramine Cardiovascular Outcomes Trial, which found a 16 percent increase in the risk of serious heart problems, including non-fatal heart attacks, non-fatal strokes, the need to be revived after cardiac arrest, and death. Those taking the drug were able to lose only a small amount of weight, the study found.
“The patients in the European SCOUT trial did not have the same characteristics as the patients for the approved indication in the United States; however, these results, combined with other available safety data raised serious questions about Meridia’s safety for all patient groups,” said Gerald Dal Pan, director of the FDA’s Office of Surveillance and Epidemiology, in the statement.
Meanwhile, the FDA also warned consumers Friday not to use a supposedly “herbal” weight-loss product sold over the Internet because it contains sibutramine.
The product is called “Slimming Beauty Bitter Orange Slimming Capsules.” Sibutramine is not listed on the product’s label and “could harm consumers,” especially those with heart conditions, the FDA said in itswarning.
“FDA lab tests reveal that the product contains excessive amounts of sibutramine that may be dangerous to people who have a history of cardiovascular disease, because it can lead to elevated blood pressure, stroke and heart attack,” the FDA said.
“Consumers who are otherwise healthy and who take the amount of sibutramine found in Slimming Beauty capsules can experience anxiety, nausea, heart palpitations, a racing heart, insomnia and elevated blood pressure. Sibutramine also may interact with other medications and can cause serious side effects,” the FDA said.
The agency said it is already aware of several reports of “serious side effects” from the use of the product, including elevated blood pressure, headaches, vomiting and insomnia.
The product is sold over the Internet by Beautiful Health Inc., formerly LL Health and Beauty, the agency said.
“The product and the sample packets are falsely labeled as ‘100% Herbal,’ ” the FDA said. “The sample packet label is misleading because it indicates that it is a natural vitamin and calcium capsule for use in children as young as 2 years old.”
Samples were distributed at the 40th Annual Mexican Independence Day Parade in Chicago on Sept. 12, the FDA said.