Health Alert: Xenical Diet Supplement Linked to Liver Damage, FDA Investigates

According to a report by Scrips News, the FDA discussed Xenical Diet Medication's, potential link to hepatoxicity at an April 16 meeting of its Drug Safety Oversight Board (DSB), and the agency is continuing to assess whether there is any correlation between the diet 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 through its original full year on the market.

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

Orlistat is the active pharmaceutical ingredient in Roche’s Xenical, which was approved as a prescription medication in 1999. Last year, GlaxoSmithKline’s Alli, a lower dosage version of the medicine, was approved for over-the-count use.

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

Hepatoxicity is chemical damage to the liver, frequently caused by drugs. The liver is the body’s major mechanism for metabolizing drugs, making it open to chemical damage. Hepatoxicity can appear in a array 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 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 association has been recognized between hepatitis and orlistat therapy.

Obesity itself is often coupled to liver damage, and the fact that the FDA is reviewing unfavorable event reports coupled with the use of Xenical and Alli does not represent that there is any cause and effect connection.

The central known side effects of Xenical and Alli comprise fatty and loose stools, fecal incontinence, repeated or pressing bowel movements and flatulence, which tend to be most severe when the remedy is started and may drop off 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 potential associations to rectal bleeding, though the bureau determined that no action was considered necessary.

It has also been suggested that Orlistat effects may swell 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 Alli Weight loss Medication may be Connected to Liver Damage, there are many safer and effective diet products for consumers to select from. Why not Seek and comapre trustworthy diet meds that are scientifically based with a long safety history?

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