Two Weight Loss Supplements Under Drug Recall Due to Undeclared Pharmaceuticals

Supplement manufacturer Bethel Nutritional Consulting has issued a voluntary drug recall for two weight loss pharmaceuticals after the FDA informed the company about undeclared pharmaceuticals.

The first drug recall involves SLIM-K capsules, which the FDA found contained undeclared Sibutramine, desmethylsibutramine, and Phenolphthalein. Sibutramine was withdrawn from the US market in 2010 because the weight loss drug can increase the risk of heart attacks, seizures, and strokes. Phenolphthalein was a laxative that is no longer sold in the US due to concerns about carcinogenicity. Concerns about the weight loss supplement’s safety led to the drug recall.

The other supplement, under a different drug recall, is called B-Lipo capsules, were found to contain Lorcaserin, a controlled substance used for weight loss; Lorcaserin can cause serious side effects including difficulty thinking, hallucinations, and feelings intense excitement, as well as potential changes in blood sugar and heart rate. The undeclared pharmaceutical can interact with other drugs that up serotonin, such as shivering, diarrhea, muscle stiffness, fever, and seizures. Severe serotonin symptoms can be fatal if not treated.

No injuries or illnesses have been reported due to taking either product, so the drug recall remains voluntary.

The FDA and Failure to Regulate Dangerous Drug Recalls

Mitchell Katz, MD, said in an editor’s note that the number of dangerous drug recalls ”grossly underestimates the number of products on sale with unapproved ingredients.” “Dietary supplements should be treated with the same rigor as pharmaceutical drugs and with the same goal: to protect consumer health,” Katz wrote.

A 2011 study conducted by Dr. Pieter Cohen, an assistant professor of medicine at Harvard Medical School, found that even supplements that had fallen under Class I dangerous drug recalls could still be purchased. According to Cohen, although the FDA issued the serious recall, it was still voluntary because the FDA has no oversight specifically over supplements.

For example, the weight loss supplement Pai You Guo, recalled in 2009 because it contained a banned dangerous drug, could still be bought in 2011. In March 2013, the FDA issued a notice to consumers that many sexual enhancement drugs contained unreported pharmaceuticals, including Viagra. Cohen suggested that consumers who want to buy supplements should stick to those with only one ingredient, or just vitamins and minerals.

Consumers could also look for supplements that have been certified by the US Pharmacopeial Convention or NSF International, which can provide assurance that the supplements do not contain illegal or unregulated pharmaceuticals.

The Strom Law Firm Can Help with Dangerous Drug Recall Cases

The Strom Law Firm, L.L.C. is a leader in the consumer protection battle against dangerous drug recalls and defective devices. We represent individuals who have been killed or injured by dangerous or defective pharmaceuticals. If you or a family member have been injured or killed after using a dangerous drugs such as dietary or weight loss supplements with undeclared ingredients, contact our dangerous drug lawyers as soon as possible so that we can begin taking steps to preserve evidence and your claim immediately. We offer free consultations to discuss the facts of your case. 803.252.4800