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Health Warning: Alli Weight loss Medication Linked to Liver Damage, FDA Investigates

By: sue cooper

According to a statement by Scrips News, the FDA discussed Alli Weight loss Product's, likely link to hepatoxicity at an April 16 meeting of its Drug Safety Oversight Board (DSB), and the bureau is continuing to assess whether there is any relation 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 during its first full year on the marketplace.

The FDA is looking at both the diet prescription and non-prescription versions of the weight loss drug and said that any proceedings taken would depend on the outcome of its analysis. The FDA would not state how many post-marketing liver damage reports it was investigating.

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

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

Hepatoxicity is chemical harm to the liver, usually caused by drugs. The liver is the body’s key mechanism for metabolizing drugs, making it disposed to chemical harm. Hepatoxicity can appear in a mixture of ways, including:

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

Xenical’s labeling already lists liver harm as a prospective side effect, stating that “exceptional cases of hepatitis that may be serious have been reported.” However, the label points out that that no direct correlation has been established between hepatitis and orlistat treatment.

Obesity itself is often related to liver harm, and the fact that the FDA is reviewing adverse event reports associated with the use of Xenical and Alli does not purport that there is any cause and effect connection.

The central known side effects of Xenical and Alli consist of oily and loose stools, fecal incontinence, numerous or urgent bowel movements and flatulence, which tend to be most serious when the treatment is started and may decrease with time.

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

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

While Alli Diet Aide may be Connected to Liver Injury, there are many safer and effective diet products for consumers to select from. Why not Research and comapre prudent weight-loss pills that are scientifically based with a long safety history?

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