For the second time in 5 years, Public Citizen, a consumer advocacy group, has issued a petition to the U.S. Food and Drug Administration (FDA) calling for the removal of the class of drugs known as orlistat, prescription brands Alli and Xenical diet pills, from the marketplace. The FDA rejected the Public Citizen’s request to take the drugs off the market in 2006. This time, the FDA received reports of 13 cases of liver failure, 73 cases of kidney stones and 47 cases of pancreatitis, which may be due to people’s consumption of the diet pills.
Dr. Sidney Wolfe of Public Citizen’s Health Research Group says that an estimated 40,000,000 people worldwide are taking or have taken these drugs during the past ten years, and the drugs “have the potential to cause significant damage to multiple critical organs.”
Dr. Richard Besser on ABC News stated, however, that he believed there is no research to establish an ironclad connection of the aforementioned maladies to these particular diet drugs. Dr. Besser, who said he is not a big diet drug fan, noted that other than diet and exercise, “there is not a lot to offer people who are trying to lose weight.” And GlaxoSmithKline™ the maker of Alli, says it “stands firmly behind the safety and efficacy of Alli,” which it notes has been examined in 100 clinical trials involving 30,000 patients.
The orlistat drugs work by blocking absorption of about a third of fat enzymes (in food) that enter the body, so that fat passes through the body to the gastrointestinal tract and is then excreted. The diet medications also block fat-soluble vitamins, including vitamins A, B, and K, which the body requires. Common negative side effects of Alli or Xenical are experienced by an estimated 20 percent of people who take the drug and include diarrhea and stool leakage, but some say these negative effects lessen over time.
Opinions, such as that of Dr. Donald Hensrud, associate professor of nutrition and preventive medicine at the Mayo Clinic, tend to muddy the water. Dr. Hensrud pointed out the [cause of the aforementioned conditions] “might not be the medication,” but “It might just be the people who would probably take these medications would already experience these effects. The data is not consistent.”
The assumption is unless more conclusive research that establishes a definite connection between deleterious effects of these drugs to human health is performed and published, the FDA will continue to allow these diet drugs to be sold—and the health of the people who take them may or may not be in jeopardy. GlaxoSmithKline’s sales of the drugs (in mid-2010) were $84 million (down from $145 million in 2007).