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FDA Examines Orlistat over Liver Damage Reports
On August 24, 2009, the US Food and Drug Administration (FDA) announced an ongoing
safety review regarding reports of liver damage and liver-related adverse events
in patients taking Orlistat, a weight-loss drug. Orlistat is marketed in the US
as the prescription drug Xenical® and as alli®, an over-the-counter version. (FDA
Website).
The FDA observed 32 reports of liver damage in patients taking alli® or
Xenical® between 1999 and October, 2008. The most commonly reported adverse events
described in these 32 reports of serious liver injury were abdominal pain, weakness,
and jaundice (yellowing of the skin or the whites of the eyes). The reports included
27 hospitalized patients with 6 who suffered liver failure.
Despite these reports,
the FDA indicated it has not established a direct association between Orlistat and
liver injury and advised patients to continue using the drug as directed. The FDA
said it would continue to review other data on suspected cases of liver injury provided
by the manufacturers of Orlistat.
Cerilliant offers certified solution standards
of Orlistat (0-032) and Orlistat Related Compound D (0-033). In addition to Orlistat,
Cerilliant also provides certified solution standards for a variety of weight-loss
drugs and their metabolites and internal standards such as Sibutramine, Phentermine,
and Fenfluramine. Click on the links below to view these featured Snap-N-Shoot®
/ Snap-N-SpikeTM solution standards:
Cerilliant Certified Reference Standards of Orlistat
Cerilliant Certified Reference Standards of Weight-Loss Drugs
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