In February 2007, the Food and Drug Administration (FDA) approved an over-the-counter version of the diet drug orlistat, more commonly known by its brand name, XENICAL. This not-so-new drug in its over-the-counter form is called ALLI, and it has been shrouded in clever marketing and misrepresentation.
Public Citizen has been very concerned about orlistat’s safety and efficacy for the past 10 years. Orlistat has been shown to cause pre-cancerous lesions of the colon, and in fact, ALLI is the first over-the-counter medication approved by the FDA that is known to cause pre-cancerous lesions.
Orlistat is also associated with nutritional deficiency due to a loss of fat-soluble vitamins. One additional reason the use of the prescription version of the drug has rapidly declined is that orlistat, because it prevents the breakdown of fat, causes a cluster of gastrointestinal symptoms relating to an excess of fat in bowel movements. These include oily spotting, flatus with discharge, fecal urgency, fatty/oily stool, oily evacuation, increased defecation, and fecal incontinence. Oily spotting and flatus with discharge occurred in about a quarter of the patients using the drug. These dangers become even more worrisome because the drug’s efficacy is minimal at best.
Below, you will find links to Public Citizen’s work and warnings about orlistat.
-
STATEMENT of Dr. Sidney Wolfe on the FDA's approval of over-the counter version of orlistat — the action is reckless. (February 2007)
-
-
COMMENTS on FDA Obesity Trial Guidelines. (April 2007)
-
PETITION filed by Public Citizen to ban this diet drug because it can cause pre-cancerous changes in the lining of the intestines. (April 2006)
-
TESTIMONY of Dr. Sidney Wolfe before the FDA on the switch of orlistat to over-the-counter status. (January 2006)
-
|
