Quoted from http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aoU_G62.eaZ0
By Catherine Larkin
Aug. 24 (Bloomberg) -- Weight-loss drugs made by GlaxoSmithKline Plc and Roche Holding AG were linked to at least 32 reports of serious liver injury from 1999 to October 2008, U.S. regulators said.
Consumers taking Glaxo’s over-the-counter drug Alli or Roche’s prescription Xenical should consult a doctor if they experience weakness, fever, jaundice or other symptoms of liver injury, the Food and Drug Administration said today in a notice posted on its Web site. The agency doesn’t recommend that patients or doctors stop using these medicines.
Both medicines contain orlistat, a chemical that blocks the intestines from absorbing fat when taken as many as three times a day with meals. The FDA approved Xenical in 1999 for weight loss and weight management in conjunction with a reduced-calorie diet. Alli, half the dose of Xenical, was cleared for non- prescription use in 2007.
“FDA is reviewing other data on suspected cases of liver injury submitted by the manufacturers of orlistat,” the agency said in its Early Communication about an Ongoing Safety Review. “FDA’s analysis of these data is ongoing and no definite association between liver injury and orlistat has been established at this time.”
Thirty of the 32 reports reviewed by FDA occurred outside the U.S., according to the notice. Six of the cases involved liver failure.