FDA warns weight loss drug may cause liver damage in rare cases

FDA puts liver damage warning on weight loss pill

WASHINGTON — Federal health officials are warning consumers that the weight loss pill alli may cause severe liver damage in rare cases.

The Food and Drug Administration says it has added a warning about the risk to the label of the drug, which is sold over-the-counter by GlaxoSmithKline. A prescription version called Xenical is made by Roche.

The FDA identified 13 instances of liver damage associated with the drugs. A causal effect between the drugs and the problem has not been established.

The FDA urged doctors and patients to watch for signs of liver injury, including itching, yellow eyes and skin and loss of appetite.

Glaxo said in a statement it is “committed to ensuring that consumers and physicians understand the safety profile” of alli.

THIS IS A BREAKING NEWS UPDATE. Check back soon for further information. AP’s earlier story is below.

WASHINGTON (AP) — Federal health officials are warning consumers that the weight loss pill alli may cause severe liver damage in rare cases.

The Food and Drug Administration says it has added a warning about the risk to the label of the drug, which is sold over-the-counter by GlaxoSmithKline. A prescription version called Xenical is marketed by Roche.

The FDA identified 13 instances of liver damage associated with the drugs. A causal effect between the drugs and the problem has not been established.

The FDA urged doctors and patients to watch for signs of liver injury, including itching, yellow eyes and skin and loss of appetite.

Glaxo said in a statement it is “committed to ensuring that consumers and physicians understand the safety profile” of alli.

(This version CORRECTS that Xenical is made by Roche, not marketed)