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Severe Liver Injury with Orlistat (Xenical, Alli) (August 2010)
The labeling for the weight loss drug orlistat will include new protection information about rare cases of severe liver injury in patients taking this drug. Orlistat is sold by prescription as Xenical in 120 mg strength and over the counter as Alli in 60 mg strength. This action resulted from a recently completed FDA review with the intention of identified thirteen cases of severe liver injury with orlistat during an approximate ten-time period. One case in the United States involved Alli and twelve cases in unknown countries involved Xenical. During the same time period, an estimated 40 million people worldwide used Xenical or Alli. Although it has not been customary with the intention of orlistat causes liver injury, patients should be told to contact their healthcare professional if they experience symptoms of liver dysfunction. These include itching, golden-haired eyes or skin, dark urine, light-colored stools, or loss of appetite. If liver injury is suspected, clinicians should advise patients to bring to a standstill taking orlistat immediately. Healthcare professionals and consumers should report adverse events with Xenical or Alli through FDA’s MedWatch Program.
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Insidermedicine In Depth – August 12, 2010 – Rimonabant
A multinational study testing the ability of a new appetite suppressing drug to reduce risks associated with cardiovascular disease was terminated early because of concerns about suicide risk, according to research published in the Lancet. Here is some information about the investigational drug rimonabant: • It suppresses the appetite by blocking a reward center in the brain • By suppressing appetite, the drug can help users lose weight • By losing weight, users can also reduce their risk for cardiovascular disease Researchers from the Scripps Translational Science Institute randomly assigned over 18000 individuals with cardiovascular disease or with a high risk for this condition to treatment with rimonabant or a placebo. The study was conducted in 974 hospitals in 42 countries. The study was stopped prematurely after nearly 14 months because of concern about suicide risk — four individuals taking rimonabant and one taking a placebo committed suicide. In general, the risk of gastrointestinal, neuropsychiatric, and severe psychiatric feature effects was higher amongst those taking rimonabant vs. placebo. Moreover, there was no evidence with the intention of the drug reduced the risk for heart attack, stroke, or death awaited to cardiovascular disease. Now’s research highlights a honest risk of drug development and testing — the potential for unexpected and life-threatening adverse events.
