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Health Warning: Alli also known as Xenical Weight-loss Supplement Connected to Liver Injury, FDA Investigates

By: sue cooper

According to a statement by Scrips News, the FDA discussed Alli Weightloss Meds's, impending link to hepatoxicity at an April 16 meeting of its Drug Safety Oversight Board (DSB), and the agency is continuing to study whether there is any relationship between the weight loss medicine and reports of liver damage. The Orlistat based diet drugs are quite popular and in 2008 alone, Xenical generated sales of $30 million and Alli generated sales of $131 million for the period of its original full year on the marketplace.

The FDA is looking at both the weightloss prescription and non-prescription versions of the weight loss medicine and stated that any proceedings taken would depend on the conclusion of its analysis. The FDA would not reveal how many post-marketing liver injury reports it was investigating.

Orlistat is the active pharmaceutical component in Roche’s Xenical, which was approved as a prescription prescription in 1999. Last year, GlaxoSmithKline’s Alli, a lower quantity form of the medicine, was approved for OTC use.

The medications are intended for use together with a condensed-calorie diet, and work by preventing the absorption of fats, in so doing reducing caloric intake in the body resulting in weight loss over time.

Hepatoxicity is chemical damage to the liver, commonly caused by drugs. The liver is the body’s key mechanism for metabolizing drugs, making it susceptible to chemical harm. Hepatoxicity can manifest in a variety of ways, including:

- Necrosis of the liver, a form of hepatitis
- Inflammation of the liver
- Vascular lesions
- Acute liver failure

Xenical’s labeling already lists liver injury as a possible side effect, stating that “exceptional cases of hepatitis that may be serious have been reported.” However, the label points out that that no direct bond has been recognized between hepatitis and orlistat therapy.

Obesity itself is often linked to liver damage, and the fact that the FDA is reviewing adverse incident reports coupled with the use of Xenical and Alli does not mean that there is any cause and effect correlation.

The primary known side effects of Xenical and Alli comprise greasy and loose stools, fecal incontinence, repeated or pressing bowel movements and flatulence, which tend to be most severe when the medication is started and may fall with time.

The FDA put orlistat on a list of drugs coupled to new safety risks earlier this year after probing reports of Xenical’s possible associations to rectal bleeding, still the bureau decided that no action was needed.

It has also been suggested that Orlistat side effects may escalate the chance of colon cancer and breast cancer, leading the consumer advocacy group Public Citizen to call for a withdrawal in 2006 of Xenical.

While Xenical Diet Aide may be Linked to Liver Damage, there are many safer and effective diet products for consumers to select from. Why not Study and comapre sound weight-loss pills that are scientifically based with a long safety history?

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