WASHINGTON — British drug maker GlaxoSmithKline is scrambling to shore up the safety image of its weight loss pill alli after watching sales dive on news that federal regulators are investigating the drug.
Alli has received a high-profile marketing push as the first over-the-counter weight loss medication, complete with television ads and a celebrity endorsement from country singer Wynonna Judd.
However, GSK has spent the last two weeks on damage control after the Food and Drug Administration said it was probing more than 30 reports of liver damage in patients taking alli and Xenical, the prescription version of the drug.
GSK executives say sales of alli dropped 10 percent after the Aug. 24 announcement, even though the FDA stressed it had established no direct link between the drug and liver problems.
GSK rushed out print advertisements in national newspapers and magazines, stressing the extensive safety testing behind the drug.
"It's the most widely studied weight-loss medicine ever, with over 100 clinical studies involving 30,000 patients," Howard Marsh, chief medical officer of GSK's consumer products division, said in an interview.
U.S. sales of alli climbed 12percent from a year ago to $42million in the last quarter, though they have come nowhere near the blockbuster numbers originally expected by Wall Street after the drug's 2007 launch.
Analysts say the brand has been hurt by lower consumer spending as well as unpleasant side effects, such as anal leakage.
GSK employs about 5,000 people in the Triangle, including many at its U.S. headquarters campus in Research Triangle Park.
The FDA first requested information from GSK about liver toxicity more than a year ago, but company executives said they had no advance warning of the August announcement.
The FDA said last month it had received 32 reports of serious liver injury among patients taking alli and Xenical between 1999 and October 2008.
The FDA release did not mention that only two of the 32 reports involved alli, something GSK and the FDA later confirmed. Xenical, marketed by Roche, has been available via prescription for 10 years.
GSK stresses that more than 6million people in the U.S. have taken alli, making two incidents of liver damage a micro-fraction of a percent.