Orlistat Warning

FDA now requiring liver-injury warning label on "popular" diet drug.
ABC World News (5/26, story 8, 0:20, Sawyer) reported, "There is a new warning about...popular weight loss drugs," medicines that have been taken by nearly "40 million people." After receiving "reports of liver damage by some users," the FDA has decided to put "a new warning on" Xenical (orlistat), developed by Roche's Genentech, "and its over-the-counter version, Alli," which is manufactured by GlaxoSmithKline (GSK), NBC Nightly News (5/26, story 9, 0:20, Williams) reported.
To date, the agency has identified "13 cases of severe liver damage associated with the drugs, one in the United States and 12 abroad," according to the Los Angeles Times (5/26, Maugh) "Booster Shots" blog. "Two of the patients died from liver failure and three others required liver transplants."
Last August, "the FDA initiated a review of the drug after receiving 32 reports of serious liver injury with hepatocellular necrosis or acute hepatic failure, 30 of them outside the US," MedPage Today (5/26, Neale) reported. The "current announcement of a labeling change comes at the end of the agency's review process."
Now, the revised label for orlistat (Xenical) will "include new safety information about rare cases of severe liver injury," Medscape (5/26, Lowes) reported. "In addition, the Drug Facts label for an over-the-counter, 60-mg formulation of orlistat (Alli) will now feature a warning about severe liver injury." The agency stated, however, that "it has not yet established a causal relationship between orlistat use and severe liver injury" for a few reasons. For instance, some of the patients in question were taking other drugs while using the diet medications, Dow Jones Newswire (5/27, Dooren) reports. Others may have had conditions that exacerbated their liver issues.
Still, HealthDay (5/26, Gardner) reported, the agency is "'telling consumers and healthcare providers to be vigilant should [patients] develop symptoms suggestive of liver impairment,' said FDA spokeswoman Elaine Gansz Bobo." She added, "We are not advising routine monitoring of liver enzymes as that will not help predict who may develop hepatic impairment on the drug."