The manufacturer of an herbal supplement that is marketed for weight loss and other purposes is voluntarily recalling capsules that contain ingredients that may increase the risk of heart problems.
Grand Prairie, Texas, Herbal Give Care reported that all lots of Esbelder man (30 capsules), Esbelder fem (30 capsules) and Esbelder siloutte (30 capsules) have been found to contain undeclared Sibutramine, N-Desmethylsibutramine, and N-di-Desmethylsibutramine. Sibutramine may increase blood pressure or pulse rate in some consumers and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
There have been no reports of adverse events, according to the company, but the presence of these undeclared ingredients makes these products unapproved drugs. Customers should stop taking the supplements immediately and return them to the source where they were purchased.
The Esbelder fem (30 capsules) was distributed nationwide under the UPC code 7502011000251; Esbelder man (30 capsules) under the UPC code 7502011000275; and Esbelder Siloutte (30 capsules) under the UPC code 7502011000268. Herbal Give Care said it is in the process of contacting distributors and customers.
Physicians and others are encouraged to report any adverse events related to Esbelder fem, Esbelder man and Esbelder Siloutte to the FDA's MedWatch Adverse Event Reporting program.