Tuesday November 20

FDA Warns Against Use of Dietary Weight Loss Aid

WASHINGTON (Reuters Health) - The US Food and Drug Administration (news - web sites) (FDA) warned consumers and healthcare professionals on Tuesday to immediately stop the use of a weight loss aid marketed under the name Lipokinetix by Cape Girardeau, Missouri-based Syntrax Innovations Inc.

The FDA said it has received at least six reports of individuals suffering acute liver failure associated with the dietary supplement. All were between 20 and 32 years old. In each case, the FDA said there was no other identifiable cause of the liver injury.

Lipokinetix contains norephedrine, also known as phenylpropanolamine (PPA), as well as caffeine, yohimbine, diiodothyronine and sodium usniate, the FDA said.

PPA is a compound once commonly used in dietary aids and cold medications that the FDA has been moving to ban. The FDA declared this intention after two studies and a committee of expert advisors to the agency concluded that the ingredient might cause strokes in young, healthy people, especially when combined with stimulants such as caffeine.

The FDA intention was announced in November. Retailers of several cold medications have since substituted other active ingredients. But there is no alternative active ingredient for the diet aids, and as a result, not all manufacturers of PPA products have jumped on the bandwagon.

In issuing the warning on Lipokinetix, the FDA encouraged consumers to consult a physician if they have experienced nausea, weakness, fatigue, fever, abdominal pain or any change in skin color.

The FDA also encouraged consumers and physicians to report any cases of liver injury or other side effects that may be related to the dietary supplement. The FDA said reports could be made by telephone at 1-800-332-1088 or on the Internet at www.fda.gov/medwatch.

Syntrax officials told Reuters Health that the product has been off the market for over a year.

No statement was available from Syntrax at press time.

http://dailynews.yahoo.com/h/nm/20011120/hl/diet_1.html