WASHINGTON (Reuters) - U.S. health officials are reviewing reports of liver injury in people who took Roche Holding AG’s weight loss drug Xenical or the over-the-counter version sold by GlaxoSmithKline.
The Food and Drug Administration said on Monday it had received 32 reports between 1999 and 2008 of serious liver injury in patients taking the drug, which is known generically as orlistat. All but two involved prescription Xenical and occurred outside the United States.
Twenty-seven patients were hospitalized, and six cases resulted in liver failure, the FDA said.
“The FDA’s analysis of these data is ongoing, and no definite association between liver injury and orlistat has been established at this time,” the agency said.
People who are taking the drug should continue to use it as directed, the FDA said.
Glaxo sells the nonprescription version under the brand name alli. The company said in a statement “there is no evidence that alli causes liver damage,” which can stem from many causes. People who are overweight or obese are predisposed
to liver-related disorders, the company said.
Glaxo also said the drug works in the gastrointestinal tract and there was “no obvious biological mechanism that would suggest liver damage can occur with alli.”
A Roche spokesman did not immediately respond to a request for comment.
Mike Krensavage, principal of Krensavage Asset Management LLC, said news of the FDA probe could hurt sales of the diet pills.
“Any time the FDA raises an issue like this, demand is likely to suffer, at least temporarily,” he said.
He noted that the drug only slightly reduces weight and has been associated with digestive problems. “If there’s a minimal benefit to begin with, risks perhaps take more of a toll on sales,” he said.
The FDA said 30 of the liver injury cases occurred outside the United States and involved 120 milligram doses of prescription Xenical. The two U.S. cases were associated with Glaxo’s nonprescription version, the FDA said. The nonprescription dose is half of the prescription dose.
Roche reported first-half 2009 sales for Xenical of 209 million Swiss francs ($197 million). Glaxo reported alli sales of $125 million for the second quarter.
People who have used orlistat should consult a doctor if they have symptoms of liver injury such as weakness, fatigue, fever, jaundice or brown urine, the FDA said.
Glaxo shares fell nearly 1.5 percent to $39.44 on the New York Stock Exchange after the FDA disclosed the probe. Roche shares earlier fell 0.4 percent in Swiss trading.
The FDA notice was posted here
Reporting by Lisa Richwine and Ransdell Pierson, Editing by Tim Dobbyn and Carol Bishopric