UPDATED: FDA Announces Recall of Supplements with Hidden Medications
The Food and Drug Administration (FDA) has announced a recall of a weight loss supplement and joint pain supplement because both contain hidden medications.
Pyrola Advanced Joint Formula is marketed for joint pain and sold online and in some retails stores. SmartLipo365 is marketed for weight loss and sold online on various websites.
An FDA laboratory analysis confirmed that Pyrola Advanced Joint Formula contains diclofenac, a non-steroidal anti-inflammatory drug (NSAID) and chlorpheniramine, an over-the-counter antihistamine.
NSAIDs may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines. This hidden drug ingredient may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products.
Antihistamines may cause drowsiness and affect mental alertness.
G&C Natural Nutrition, Inc. recalled all lots of the supplement, following an FDA consumer advisory issued last week. Distributers are urged to discontinue selling the supplement and consumers who may have purchased this product directly from G&C Natural Nutrition, Inc. should dispose it or return it by mail. Consumers with questions regarding this recall can contact G&C Natural Nutrition, Inc. at (800) 970-8198 or by email at email@example.com.
The maker of SmartLipo365 is voluntarily recalling 122 lots of Smart Lipo (800, 900, 950 mg) capsules, because FDA lab results found undeclared sibutramine, desmethylsibutramine, and phenolphthalein.
Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010. 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.
Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not currently approved for marketing in the United States. Health risks associated with phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use.
These undeclared ingredients make these products unapproved new drugs for which safety and efficacy have not been established. These products may also interact in life-threatening ways with other medications a consumer may be taking.
SmartLipo365 is notifying its distributors and customers by e-mail and letter and will not continue the distribution of the product. Consumers, distributors, retailers are asked to dispose of the supplements.
Consumers with questions regarding this recall can contact SmartLipo365 by 1-(800)-547-6365 or firstname.lastname@example.org.
Health care professionals and patients are encouraged to report adverse events or side effects related to the use of this product to FDA's MedWatch Safety Information and Adverse Event Reporting Program.