UPDATE 3-US warns of liver risk with Glaxo, Roche diet drugs

* New warnings added to Xenical, Alli

* FDA says liver damage reports are rare

* Glaxo shares down 0.6 percent
(Adds Glaxo comment, sales figures, byline; updates shares)

By Lisa Richwine

WASHINGTON, May 26 (BestGrowthStock) – Weight-loss drugs from
GlaxoSmithKline PLC (GSK.N: ) and Roche Holding AG (ROG.VX: ) will
carry new warnings about rare reports of liver injury, U.S.
health officials said on Wednesday.

The Food and Drug Administration said it had not determined
that Roche’s prescription drug Xenical or Glaxo’s
over-the-counter pill Alli caused liver damage, but felt the
public should be alerted because the condition is serious.

Patients should stop taking either medicine and consult a
doctor if they notice any signs of liver injury, the FDA said.
Symptoms may include itching, yellow eyes or skin, dark urine,
light-colored stools or loss of appetite.

The FDA said it reviewed 12 cases of severe liver damage in
patients outside the United States who took Xenical, and one in
a U.S. patient who took Alli. Two died and three needed liver
transplants.

Some patients took other drugs or had conditions that may
have contributed to liver damage, the FDA said.

An estimated 40 million people worldwide have taken Xenical
or Alli, the FDA said. Both medicines contain the ingredient
orlistat. Xenical was approved in 1999 and Alli, which contains
half the amount of orlistat as Xenical, was cleared in 2007.

Roche said in a statement the company and the FDA agreed to
add the information about liver damage to the precautions
listed on Xenical’s prescribing instructions.

“We will continue to monitor the safety profile of Xenical
and provide this information to the FDA,” the company said.

Alli’s label will warn patients about rare reports of liver
injury and its symptoms, Glaxo said.

The company “wants people to have the information they need
to choose the right weight loss aid for their situation,” Dr.
Howard Marsh, chief medical officer for GSK Consumer
Healthcare, said in a statement.

Alli’s global sales totaled about $317 million in 2009.
Worldwide sales of Xenical in 2009 hit about 400 million Swiss
francs ($345 million).

Glaxo shares slid 0.6 percent to $32.74 in afternoon
trading on the New York Stock Exchange. Roche shares closed 1.3
percent higher in Swiss trading.

Money

(Reporting by Lisa Richwine; editing by Gunna Dickson and
Maureen Bavdek)

UPDATE 3-US warns of liver risk with Glaxo, Roche diet drugs