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orlistat (ALLI, XENICAL)

• orlistat (ALLI, XENICAL)
  We list this drug as a Do Not Use drug because it has not been shown to cause long-term health benefits.

• Diet Drugs [hide all summaries]
  The FDA has set the bar too low for the approval of diet drugs. Instead of requiring that diet drugs be proved to prevent the long term consequences of obesity (none ever has), diet drugs can be approved if they show a modest weight loss over a relatively short period.

• The Diet Drug Orlistat (XENICAL) and Gallstones [hide all summaries]
  (June 2007)
  Yet another problem has been detected with this diet drug whose approval we opposed and that we have been attempting to get banned. The FDA found 37 cases of gall stones in patients using orlistat. This, in addition to inhibiting the absorption of important vitamins such as A, D, E and K as well as evidence that the drug can cause pre-cancerous abnormalities in the colon of animals, further emphasizes why this barely effective drug should not be used, either in the prescription version called Xenical or the about-to-appear over-the-counter version, Alli.
• Public Citizen Asks FDA to Immediately Remove Orlistat (XENICAL) from the Market [hide all summaries]
  (June 2006)
  Public Citizen petitioned the Food and Drug Administration (FDA) on Apr. 10, 2006 to immediately remove the diet drug orlistat (XENICAL) from the market. The basis for the petition is the fact that orlistat can cause pre-cancerous changes in the lining of the intestines called aberrant crypt foci (ACF). You should not take orlistat. There is no evidence that this drug can reduce the health risks associated with obesity and inactivity, and the drug's minimal effectiveness for weight loss-coupled with both the real and theoretical risks of orlistat-outweigh any known benefit for the drug.

• FDA Approval of Over-the-Counter Orlistat Is Reckless [hide all summaries]
  Statement of Dr. Sidney M. Wolfe, Director of Public Citizen’s Health Research Group
• Statement Before the Institute of Medicine Committee on Developing Cancer Biomarkers: A Case Study Involving ACF/orlistat (HRG Publication #1773) [hide all summaries]
  Why Not for Harm Prevention as Well? A Case Study Involving ACF/orlistat
• Supplement to petition to ban diet drug orlistat (XENICAL). Additional information provided about pre-cancerous changes to the colon (HRG Publication #1771) [hide all summaries]
  There is more than enough evidence to take orlistat off the market as a prescription drug and thereby end the process of switching it to over-the-counter status.
• Petition to the FDA to immediately remove the diet drug orlistat (XENICAL) from the market (HRG Publication #1764) [hide all summaries]
  This drug, which treats obesity, causes a significant increase in the incidence of aberrant crypt foci, which are widely believed to be a precursor of colon cancer.
• Testimony Before the FDA Advisory Committees on Possible Switch of Orlistat (XENICAL) to OTC Status (HRG Publication #1760) [hide all summaries]
  Before the FDA Non-Prescription and Endocrine and Metabolic Drug Advisory Committees Hearing on Possible Switch of Orlistat (XENICAL)to OTC Status (HRG Publication #1760)
• Comments before the Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee on orlistat (Xenical) for the treatment of obesity. (HRG Publication #1417) [hide all summaries]
  It is troubling that important information about orlistat has been kept secret, and the time allotted for public participation is in the hour before any presentations will reveal what is known about orlistat. Scheduling public comment later in the meeting, after presentation of what we believe are numerous studies involving large numbers of subjects(2), without the time to carefully evaluate these data is little better than keeping the data secret.

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