FDA urges people to stop taking Limbrel
People taking Limbrel should stop immediately and contact their health care provider, the Food and Drug Administration says in a safety alert issued Monday.
The capsule is marketed as a “medical food” that helps people suffering from osteoarthritis. The agency contends it's actually an unapproved new drug with serious side effects including liver damage and a lung inflammation called hypersensitivity pneumonitis .
The agency has asked the manufacturer, Primus Pharmaceuticals in Scottsdale, Ariz., to recall the product but the company hasn't done that, the safety alert says.
The company believes the benefits of Limbrel, which is available only through prescription, outweigh the side effects, said Mary Ann DeMarco, an executive director with Primus Pharmaceuticals.
While the FDA is claiming the product is a drug based on some of its components, the company has submitted evidence to the agency that its components are found in the food supply, she said.
“We believe that it's a medical food and that it's not potentially fatal,” DeMarco said.
Some people who take Limbrel develop acute hypersensitivity pneumonitis, but the symptoms disappear when they stop. The evidence for elevated liver enzymes doesn't rule out other possible causes, she said.
“We stand strong on Limbrel's safety,” DeMarco said.