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Diet Pills May Be Causing Liver Damage

Jul 6, 2009 | Parker Waichman LLP

The fat absorption inhibiting diet pill, Alli, is being investigated over concerns that it is associated with liver damage. According to the Daily Mail, Alli is the first such diet pill to be available to consumers without a prescription. Earlier last month we wrote that drugs containing orlistat were among 20 medications undergoing a U.S. Food and Drug Administration (FDA) safety review, orlistat for risks of liver injury.

Orlistat is the main ingredient in Alli and now, the FDA is looking into alerts received from patients who have reported side effects wile taking orlistat. Also, the Medicines and Healthcare products Regulatory Agency (MHRA), which oversees drugs in the United Kingdom, received 31 reports of side effects linked to orlistat since April when Alli was launched there, said the Daily Mail.

MHRA could not confirm if the reports were connected to Alli or the stronger, prescription strength Xenical, said the Daily Mail. Both Alli and Xenical contain orlistat. Of note, since Xenical’s launch in Great Britain in 2001, 24 people taking the drug have died, said the Daily Mail. One person died of liver failure, with others dying from “heart attacks, gall bladder inflammation, multi-organ failure, and lung clots”; five cases in which patients suffered sudden death had no clear-cut cause, said the Daily Mail, which noted that MHRA received 1,252 reports of potential side effects from patients that involved an array of issues including heart, gastrointestinal, skin, and liver problems.

Earlier this year we wrote about a new study that found that orlistat did not seem to help patients with Fatty Liver Disease (FLD), its targeted demographic.  Science Daily explained at the time that a randomized, prospective trial revealed orlistat not only does not help patients suffering from FLD lose weight, it does not improve those patients’ liver enzymes or insulin resistance. MedPageToday further explained that the study found no improvement in hepatic outcomes in patients with nonalcoholic FLD—a possible result of obesity—when Orlistat was added to a lower-calorie diet.

Because many find diet and exercise daunting in their quest for a healthy body, dieters are turning to medications containing orlistat, such as prescription strength Xenical and over-the-counter (OTC) Alli. According to pharmaceutical giant GlaxoSmithKline (GSK), the maker of Alli, Alli is allegedly supposed to assist in weight loss by up to 50 percent, said the Daily Mail. In other words for every two pounds a dieter loses, he/she can lose an additional pound when taking Alli.

Regarding the earlier study, “Comparing the orlistat group to the nonorlistat group at study completion, no significant differences were identified between the two groups for mean weight loss, serum, insulin resistance, or cholesterol,” Science Daily quoted the team as stating.  Also, liver biopsy findings revealed no significant differences.

In 2006 we wrote about Roche Holding AG’s attempts to obtain approval of Xenical as the first OTC drug of its kind. At that time, consumer watchdog, Public Citizen, was seeking to have even the prescription form of the drug pulled from the market. That petition, which was filed with the FDA was joined by researchers from Case Western Reserve University School of Medicine who maintained that Xenical is linked to pre-cancerous changes in the lining of the intestinal tract, believed to be a precursor to colon cancer. A review of reported post-approval side effects conducted by the group also found 28 cases of breast cancer in patients taking Xenical.

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