While Xenical is the weight loss drug from the repertoire of Roche Holding AG, both Xenical and Alli (known as orlistat) are marketed by British drug maker GlaxoSmithKline PLC. Alli is the only non-prescription weight loss drug approved by the agency.
No definite relation established
32 complaints of serious liver injury reported between 1999 and 2008 prompted the FDA to initiate the investigation. Out of these, 27 patients were hospitalized, while six cases resulted in liver failure. These patients were on 120 milligram doses of prescription Xenical.
"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 clarified.
The agency also suggested that patients should continue to take the drug as directed.
"Consumers should consult their health care professional if they are experiencing symptoms," advised the FDA. Symptoms of liver damage include fatigue, fever, nausea and vomiting, added the agency.
The drug maker’s stand
Glaxo claimed that "there is no evidence that alli causes liver damage." The company suggested that the there could be various reasons for liver damage. As it is, overweight and obese people are more vulnerable to the disease.
The company explained that orlistat works in the gastrointestinal tract and there was "no obvious biological mechanism that would suggest liver damage can occur with alli."
Glaxo admitted that Alli has been associated with slight digestive problems. Overall, Alli's safety has been established in more than 100 clinical studies involving over 30,000 patients. Orlistat has been approved for use in over 100 countries.
Xenical got the FDA approval way back in 1999. Alli, however, got the green light from the FDA in 2007 as an over-the-counter (OTC) drug. The prescription pill is reportedly twice as effective as Alli. The latter garnered $123 million in sales for Glaxo last year, while Xenical contributed $472 million in revenue for Roche.
The news of the FDA enquiry is, nonetheless, likely to have an adverse impact on the sales of the drugs, at least for the time being.
London based Glaxo’s shares fell 1.5 percent to $39.44 on the NYSE on the news of the FDA probe. Likewise, shares of Switzerland based Roche fell 0.4 percent in Swiss trading.
GSK a Good Company
GSK is a good company, and they would never knowingly release a product that causes liver damage. I'm sure this investigation will clear their name. LASIK Eye Surgery in Grand Rapids, MI
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