KEY POINTS

  • Dietary supplement Miss Slim USA is said to contain sibutramine
  • Sibutramine was once an FDA-approved drug as an appetite suppressant
  • It was withdrawn from the U.S. market in 2010
  • The drug is known to increase blood pressure and pose risks to certain people

A New Jersey-based company, HIS, is recalling its dietary supplement "Miss Slim USA" nationwide due to "undeclared sibutramine."

The recall affects "all lots and all presentations" of the product, the company announcement posted on the U.S. Food and Drug Administration (FDA) website noted. It is being sold as a dietary supplement for weight loss and comes in 10-count (UPC 742137605030) and 30-count (UPC 609728434472) capsules.

According to the announcement, the company is voluntarily recalling the product after the FDA contacted it about the presence of sibutramine in it. Although sibutramine was once an FDA-approved drug as an appetite suppressant, it was withdrawn from the U.S. market in October 2010 because of certain safety issues. As such, its presence in the product makes it an "unapproved drug for which safety and efficacy have not been established."

"Products containing sibutramine pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke," the risk statement in the company announcement explained.

The product was sold online via the company's website. Those who may have purchased the product are being advised not to use it and to contact their healthcare provider if they experienced any adverse effects possibly related to using the product. So far, the company has not yet received any reports of "adverse events" in connection with the recall.

"HIS is notifying its customers by website missslimusa.com and is arranging for return of all recalled products," the company said.

Weight Loss Dietary Supplements

Unlike over-the-counter and prescription drugs, dietary supplements, such as the ones for weight loss, don't need to be reviewed or approved by the FDA before they are sold in the market, the National Institutes of Health (NIH) said. Moreover, they are not required to provide the FDA with proof of the product's safety or effectiveness.

However, the FDA can remove a supplement from the market or ask the company to issue a recall if they find that a dietary supplement may be unsafe. Apart from possible side effects, the agency also looks at the possibility that the supplement may interact with other prescription or over-the-counter drugs that an individual may also be taking.

"Tell your healthcare providers about any weight-loss supplements or other supplements you take," the NIH said. "This information will help them work with you to prevent supplement-drug interactions, harmful side effects, and other risks."

Pills An illustration picture taken in Lille, France, shows pills, tablets, caplets and capsules of medicine, May 7, 2017. Photo: Getty Images