Pharmaceutical Drug Litigation Updates

EU regulator to review anti-obesity medicines

Quoted from http://www.reuters.com/article/2011/09/22/us-eu-regulator-idUSTRE78L64220110922

EU regulator to review anti-obesity medicines

LONDON | Thu Sep 22, 2011 4:29pm EDT

LONDON (Reuters) - The European Medicines Agency said it would look into anti-obesity medicines that contain orlistat, including Roche's Xenical and GlaxoSmithKline's Alli.

Its move follows some rare cases of severe liver injury that could affect the drugs' benefit-risk profile.

The EMA, the European Union's drug regulator, said the review would include the prescription-only medicine Xenical (orlistat 120 mg), and the lower dose over-the-counter-medicine Alli, as well as other medicines containing orlistat.

The risk of liver reactions was well known, the agency said in a statement on Thursday, and had been kept under close review. Its new probe focused on the strength of evidence relating to severe liver injury.

It said there were 21 suspected cases of liver injury, of which four were severe, reported among patients taking orlistat 120 mg between August 2008 and January 2011.

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Watchdog group makes second push to ban diet pill

Quoted from http://www.app.com/article/20110414/NJBIZ/304140017/Watchdog-group-makes-second-push-to-ban-diet-pill

Watchdog group makes second push to ban diet pill

11:35 AM, Apr. 14, 2011|

Associated Press

WASHINGTON — For the second time in five years, public health advocates are calling on the Food and Drug Administration to ban a fat-blocking drug sold over-the counter and via prescription, pointing to new reports of kidney stones and pancreatic damage.

Public Citizen filed a petition with the FDA Thursday calling on the agency to remove GlaxoSmithKline’s Alli and Roche’s Xenical from the market. Alli is sold over-the-counter while Xenical, a higher dose of the drug, is only available with a doctor’s prescription. Sales of both versions have been declining for years.

Public Citizen says it identified 47 cases of acute pancreatitis and 73 kidney stones among patients taking the drugs. The reports were culled from the FDA’s public database of negative drug reactions.

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The FDA cites rare risk of liver damage with weight-loss drugs Xenical and Alli

Quoted from http://latimesblogs.latimes.com/booster_shots/2010/05/fda-rare-risk-liver-damage-xenical-alli.html

The FDA cites rare risk of liver damage with weight-loss drugs Xenical and Alli

May 26, 2010 | 11:02 am

The Food and Drug Administration said Wednesday that it is ordering a revision of the labels of the weight-loss drugs Xenical and Alli to warn of the risk of very rare cases of severe liver damage associated with their use. The active ingredient in both drugs is orlistat, which blocks the absorption of fats in the intestines. Xenical is a prescription form of the drug. Alli is an-over-the-counter version which contains lower doses.

The agency said it had identified 13 cases of severe liver damage associated with the drugs, one in the United States and 12 abroad. Two of the patients died from liver failure and three others required liver transplants. The FDA said it could not positively say that the drug caused the damage because there is insufficient data in most of the cases. Some of the patients, for example, might have been taking other drugs or had other medical conditions that could have caused the injury. Worldwide, more than 40 million people have taken either Xenical or Alli, so the cases are very rare.

Patients taking the drugs should contact their physicians if they develop itching, yellow eyes or skin, dark urine, loss of appetite, or light-colored stools, all of which are signs of liver damage.

GSK guards pill's image amid probe

Quoted from http://www.newsobserver.com/business/story/1688217.html

GSK guards pill's image amid probe

Diet pill sales have taken a hit

BY MATTHEW PERRONE - The Associated Press

Mon, Sep. 14, 2009 02:00AM

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....

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Glaxo, Roche Weight-Loss Drugs Linked to Liver Injury

Quoted from http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aoU_G62.eaZ0

Glaxo, Roche Weight-Loss Drugs Linked to Liver Injury

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.