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【drug-news】FDA调查赛尼可的肝脏不良反应
August 25, 2009 — The US Food and Drug Administration (FDA) has warned healthcare professionals about the potential for liver-related adverse events with the weight-loss drug orlistat (Xenical, Roche).
A report from MedWatch, the FDA's safety information and adverse event reporting program, indicates that 32 cases of serious liver injury have been reported, including 6 cases of liver failure. Common adverse events observed were jaundice, abdominal pain, and weakness. Of the adverse events reported, 30 occurred outside the United States.
"In addition to the 32 reported cases, this issue was discussed at the [Center for Drug Evaluation and Research] Drug Safety Oversight Board in April 2009, and FDA is reviewing other data on suspected cases of liver injury submitted by the manufacturers of orlistat," the FDA notes in an early communication about an ongoing safety review.
No strong association has yet been found between orlistat and liver injury, but analysis of data regarding other suspected cases of liver injury is ongoing. The FDA is not recommending any changes to prescribing practices at this time for either the prescription or over-the-counter product.
Orlistat is currently marketed in approximately 100 countries. Xenical was approved as a prescription product in the United States in 1999 for obesity management in conjunction with a reduced caloric diet and to reduce the risk of regaining weight after prior weight loss. In 2007, this agent at a lower dose was approved as an over-the-counter product for weight loss in overweight adults aged 18 years and older in conjunction with a reduced-calorie and low-fat diet.
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作者:admin@医学,生命科学 2010-11-13 17:11
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