Saturday, August 30, 2014
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Diet drug dangers lead to label change, FDA announces

The Food and Drug Administration announced that the over-the-counter diet-drug Alli by local pharmaceutical powerhouse GlaxoSmithKline has changed its label to warn consumers that the medication has been linked to reports of severe liver injury. Alli helps overweight people lose weight by decreasing the amount of fat absorbed by the intestines and thus reducing calorie intake. A prescription version of the drug called orlistat for the active ingredient is also available at double the dosage. The prescription version is made by Roche and goes by the brand name Xenical.

Diet drug dangers lead to label change, FDA announces

The Food and Drug Administration announced that the over-the-counter diet-drug Alli by local pharmaceutical powerhouse GlaxoSmithKline has changed its label to warn consumers that the medication has been linked to reports of severe liver injury.

Alli helps overweight people lose weight by decreasing the amount of fat absorbed by the intestines and thus reducing calorie intake. A prescription version of the drug called orlistat for the active ingredient is also available at double the dosage. The prescription version is made by Roche and goes by the brand name Xenical.

The FDA notice to doctors, other prescribers and patients stated:

FDA notified healthcare professionals and patients that it has approved a revised label for Xenical to include new safety information about cases of severe liver injury that have been reported rarely with the use of this medication. The agency is also adding a new warning about rare reports of severe liver injury to the OTC Drug Facts label for Alli.

Xenical and Alli are medications used for weight-loss that contain different strengths of the same active ingredient, orlistat. Xenical (orlistat 120 mg) is available by prescription and Alli (orlistat 60 mg) is sold over-the-counter without a prescription. This new safety information, originally announced in August 2009, is based on FDA's completed review of orlistat.

Healthcare professionals should weigh the benefits of weight-loss with the potential risks associated with Xenical and Alli before prescribing or recommending these medications to their patients; patients should stop use of orlistat and contact their healthcare professional if they develop the signs and symptoms of liver injury, including itching, yellow eyes or skin, dark urine, light-colored stools, or loss of appetite.

The drug agency also included a Q&S sheet about the drug available by clicking here and a more detailed announcement of the safety issues, which notes that it has received 13 reports of patients in the U.S. who have experienced severe liver injury from the drugs – 12 after taking Xenical and one from Alli. Two patients died from liver failure and  three more patients required liver transplants, the FDA said.

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Check Up covers major health events in our region and offers everything from personal health advice to an expert look at health reform. Read about some of our bloggers here.

For Inquirer.com. Portions of this blog may also be found in the Inquirer's Sunday Health Section

Michael R. Cohen, R.Ph. President, Institute for Safe Medication Practices
Daniel R. Hoffman, Ph.D. President, Pharmaceutical Business Research Associates
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