FDA issues alert about tainted weight loss pills
Twenty-eight products contain undeclared, active pharmaceutical ingredients.
The FDA is seeking a recall of weight loss products containing undeclared, active pharmaceutical ingredients, such as sibutramine, rimonabant, phenytoin and phenolphthalein, that pose serious health risks for consumers.
More than 25 different weight loss products are implicated in the official FDA alert (see table). An FDA analysis found levels of sibutramine, rimonabant, phenytoin and phenolphthalein that far exceeded FDA-recommended levels.
These tainted weight loss products pose a great risk to public health because they contain undeclared ingredients and, in some cases, contain prescription drugs in amounts that greatly exceed their maximum recommended dosages. Consumers have no way of knowing that these products contain powerful drugs that could cause serious health consequences, Janet Woodcock, MD, director of the FDA Center for Drug Evaluation and Research, said in a press release.
The FDA advised health care professionals to encourage patients to stop taking these products.
The health risks associated with these tainted products are potentially serious. For example, sibutramine can cause seizures, tachycardia, hypertension, palpitations, myocardial infarction and/or stroke. Rimonabant, which is not approved by the FDA for marketing in the United States, has been linked with increased risk for depression and suicidal thoughts.
The flagged weight loss products have not been approved by the FDA, are illegal and may be potentially harmful to unsuspecting consumers, according to the agency. Most are marketed as dietary supplements, natural and herbal.
The FDA is currently seeking product recalls and conducting inspections at a number of companies. The agency may take additional enforcement steps, such as issuing warning letters or initiating seizures, injunctions or criminal charges if it encounters inadequate responses to recall requests.
Health care professionals are encouraged to report serious adverse events to the FDAs MedWatch Adverse Event Reporting program.
For more information, visit www.fda.gov.
Tainted Weight Loss Products Containing Undeclared, Active Pharmaceutical Ingredients