On Friday the US Food and Drug Administration (FDA) named 72 weight loss products found to contain undeclared pharmaceutical ingredients, include prescription drugs in doses that the agency said could lead to serious health consequences.
The latest announcement is the second update to a list they issued last December, when they named 28 products marketed for weight loss. In January 2009 this was updated to a total of 68, and now, following further investigation the federal agency is adding four products to the list: Herbal Xenicol, Slimbionic, and Xsvelten.
The FDA have also added four more undeclared pharmaceutical compounds found in the tainted products: fenproporex, fluoxetine, furosemide, and cetilistat.
Dr Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (CDER) said in a press statement that:
“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 maximum recommended dosages.”
“Consumers have no way of knowing that these products contain dangerous drugs that could cause serious consequences to their health,” she added.
The products are mostly marketed as dietary supplements and sold via the internet, plus retail stores and beauty parlours. The packaging and advertising uses phrases like “natural”, or claim to contain only “herbal” ingredients, but the FDA found they contain the following undeclared pharmaceutical drugs:
- Fenproporex – a controlled substance not approved for sale in the US.
- Fluoxetine – an antidepressant (available only via prescription).
- Bumetanide and furosemide – potent diuretics (available only via prescription).
- Rimonabant – a drug not approved for sale in the US.
- Cetilistat – an experimental drug for treating obesity; not approved for sale in the US.
- Phenytoin – an anti-seizure medication drug (available only via prescription).
- Phenolphthalein – a solution used in chemical experiments; also suspected of causing cancer and not approved for sale in the US.
- Sibutramine – a controlled substance used in the FDA approved drug Meridia. This was found in dosages much higher than that contained in the approved drug.
These products can cause serious health problems including high blood pressure, seizures, tachycardia (rapid heartbeat), palpitations, heart attack, and stroke, alerted the FDA.
The higher levels of sibutramine can increase the incidence and severity of these health risks, said the agency, adding that the other controlled substance, fenproporex also found in some of the products, can cause arrhythmia and sudden death.
Consumers using any of the 72 products on the list should stop taking them and tell their doctor at once, said the FDA.
The agency also said if you are thinking about using weight loss products you should talk to a health professional first.
The FDA has inspected several companies associated with these products and is getting them to recall them all. The agency has powers to escalate enforcement such as issuing warning letters, seizing goods, to initiating criminal charges.
The FDA investigation is ongoing and the list will be updated in line with any further discoveries.
Sources: FDA.
Written by: Catharine Paddock, PhD