The Food and Drug Administration announced today that regulators are assessing at least 32 reports of liver problems between 1999 and 2008 in patients taking the weight-loss drug orlistat, sold as a prescription drug Xenical and more recently, as an over-the-counter medication called Alli.
Of the 32 reports of liver problems the FDA has in hand, 27 patients were hospitalized and six suffered liver failure. In an "early communication" of a drug safety review, the FDA said it will also review additional data on "suspected cases of liver injury" submitted by drug firms that make and market orlistat in its branded and generic forms. Orlistat was originally marketed, and still is, by Roche Pharmaceuticals as Xenical, a prescription drug. The medication, which blocks the absorption of fat through the digestive tract, gained approval as an over-the-counter drug in 2007, and is marketed as Alli by GlaxoSmithKline. Orlistat has been approved for use in 100 countries.
Publicamos que se l@ "estaban poniendo gord@".
Se confirman las sospechas...
Ahora FDA duda de su "seguridad hepática":
"Between 1999 and October 2008, 32 reports of serious liver injury, including 6 cases of liver failure, in patients using orlistat were submitted to FDA’s Adverse Event Reporting System. The most commonly reported adverse events described in the 32 reports of serious liver injury were jaundice, weakness, and abdominal pain.
FDA is reviewing other data on suspected cases of liver injury submitted by the manufacturers of orlistat, analysis of these data is ongoing and no definite association between liver injury and orlistat has been established at this time. FDA is not advising healthcare professionals to change their prescribing practices with orlistat.Consumers currently taking Xenical should continue to take it as prescribed and those using over-the-counter Alli should continue to use the product as directed.
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