Fake forms of Glaxo diet drug can be dangerous: FDA

By Lisa Richwine

WASHINGTON (Reuters) - Fake versions of GlaxoSmithKline's over-the-counter diet pill were contaminated with dangerously high levels of a prescription weight loss ingredient, U.S. officials warned on Saturday.

Lab tests showed counterfeit versions of Glaxo's pill Alli contained high levels of sibutramine, Food and Drug Administration officials said.

Sibutramine is the active ingredient in Abbott Laboratories Inc's prescription diet drug Meridia.

"The amount of sibutramine in the counterfeit Alli poses a serious health risk to some individuals," Dr. Janet Woodcock, head of the FDA's drug unit, told reporters on a conference call.

"A person taking the counterfeit Alli as directed would be exposed to twice the maximum prescription dose of sibutramine every day," she said.

The FDA warned earlier this week that sibutramine should not be used by people with a history of cardiovascular disease because it can raise the risk of heart attacks and strokes.

Regulators in Europe concluded sibutramine was too risky and Abbott agreed to suspend sales there.

Woodcock said even healthy people exposed to the counterfeit Alli pills could experience effects including palpitations, sleepiness, anxiety, nausea and slightly elevated blood pressure.

The fake versions were sold on the Internet, including through online auction sites, FDA officials said. There is no evidence of counterfeit versions in stores, they said.

The fake products were sold as 60-milligram, 120-count refill packages only, Glaxo said. The company said it was working with the FDA to have the counterfeits removed from online auction sites.

The agency urged all consumers taking Alli to check they had bought legitimate versions and discard any fake products immediately.

The fake versions have some differences on the packaging, including a missing lot code on the outer cardboard packaging. The FDA posted links to photographs of Glaxo's approved versions and the counterfeits here