Alli weight loss warning
This information is an update to the Early Communication about an Ongoing Safety Review Orlistat (marketed as Alli and Xenical) issued on August 24, 2009. The agency is also adding a new warning about rare reports of severe liver injury to the OTC Drug Facts label for Alli and is working with the manufacturer to ensure that consumers can understand this new warning. case with Alli and 12 foreign cases with Xenical reported between April 1999 and August 2009 out of an estimated 40 million people worldwide who have used Xenical or Alli. However, there is no evidence at this time that the counterfeit Alli product has been sold through other channels, such as retail stores. Because of the seriousness of severe liver injury, FDA has added information about reported cases of severe liver injury to the label of Xenical and Alli to educate the public about the signs and symptoms of liver injury and the need to see a physician promptly should they occur. Sibutramine is a drug that should not be used in certain patient populations or without physician oversight. Postmarket Drug Safety Information for Patients and Providers. Xenical (orlistat 120 mg) is available by prescription and Alli (orlistat 60 mg) is sold over-the-counter without a prescription. Safety Announcement Additional Information for Patients and Consumers Additional Information for Healthcare Professionals. Instead, the counterfeit product contained the controlled substance sibutramine. This content has not been altered or updated since it was archived. Sibutramine can also interact in a harmful way with other medications the consumer may be taking. Severe liver injury can occur in people not taking drugs and without a distinct cause. Some patients in the reported cases also used other drugs or had other conditions that may have contributed to the development of severe liver injury.
The U. Preliminary laboratory tests conducted by GlaxoSmithKline (GSK)—the maker of the FDA approved over-the-counter weight-loss product— revealed that the counterfeit version did not contain orlistat, the active ingredient in its product. The following factors make confirming a cause-and-effect relationship between orlistat and severe liver injury difficult: One U. This content has not been altered or updated since it was archived. Food and Drug Administration is today warning consumers about a counterfeit and potentially harmful version of Alli 60 mg capsules (120 count refill kit). Consumers began reporting suspected counterfeit Alli to GSK in early December 2009. The content on this page is provided for reference purposes only. The content on this page is provided for reference purposes only. GSK has determined that the counterfeit product has been sold over the internet. S. S. At this time, a cause and effect relationship of severe liver injury with orlistat use has not been established. Xenical and Alli are medications used for weight-loss that contain different strengths of the same active ingredient, orlistat.
