FDA INVESTIGATING WEIGHT-LOSS DRUG: COULD LAWSUITS FOLLOW?
The U.S. Food and Drug Administration (FDA) announced on August 24 that it is investigating reports of liver damage among patients taking orlistat, a popular weight loss drug marketed as prescription Xenical and the over-the-counter Alli.
Though orlistat in its prescription form appeared in 1999, Alli became the first non-prescription drug approved in America to treat obesity in 2007. The difference between the two versions is dosage – 120 milligrams versus 60 milligrams. Though diet drugs are becoming increasingly popular, some doctors have noted that the benefits of this particular one may be rather modest – a weight loss of perhaps ten pounds in conjunction with diet and exercise.
The FDA has so far received 32 reports of adverse liver effects in patients taking the drug in the past ten years, including instances of jaundice, weakness, and stomach pain. There is not yet any definite link between orlistat and these symptoms, and the FDA has not recommended that patients taking either Xenical or Alli should discontinue use – but did note that anyone experiencing these symptoms should consult a doctor.
Diet drugs and supplements have proven to be a persistent problem for the FDA, and a persistent presence in the legal community. Earlier this summer, the recall of Hydroxycut was also prompted by concerns about liver damage, and of course, lawsuits over fen-phen are still ongoing. There have already been tens of thousands of cases concerning the now-banned diet drug, including a one billion dollar award for one plaintiff. Will Xenical and Alli prompt similar lawsuits? Only time will tell.
Though orlistat in its prescription form appeared in 1999, Alli became the first non-prescription drug approved in America to treat obesity in 2007. The difference between the two versions is dosage – 120 milligrams versus 60 milligrams. Though diet drugs are becoming increasingly popular, some doctors have noted that the benefits of this particular one may be rather modest – a weight loss of perhaps ten pounds in conjunction with diet and exercise.
The FDA has so far received 32 reports of adverse liver effects in patients taking the drug in the past ten years, including instances of jaundice, weakness, and stomach pain. There is not yet any definite link between orlistat and these symptoms, and the FDA has not recommended that patients taking either Xenical or Alli should discontinue use – but did note that anyone experiencing these symptoms should consult a doctor.
Diet drugs and supplements have proven to be a persistent problem for the FDA, and a persistent presence in the legal community. Earlier this summer, the recall of Hydroxycut was also prompted by concerns about liver damage, and of course, lawsuits over fen-phen are still ongoing. There have already been tens of thousands of cases concerning the now-banned diet drug, including a one billion dollar award for one plaintiff. Will Xenical and Alli prompt similar lawsuits? Only time will tell.
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