Orlistat Side Effects

Orlistat (also referred to as Xenical) is a lipase-inhibitor drug designed by Hoffman La-Roche Laboratories to help obese individuals lose and maintain their body weight. The drug works by preventing fat from being absorbed by the body but can cause excess gas, oily discharge and other gastrointestinal problems. Although this may sound like a miracle weight loss drug, it has hidden cancer risks which are emerging that clearly outweigh any possible benefit the drug may have. According to research studies, people who use it have a higher risk of developing both colon cancer and breast cancer.

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Colon cancer concerns have spurred the consumer advocate group, Public Citizen, to petition the FDA asking it to withdraw the prescription diet drug from the market; the group also wants the FDA to refuse approval for the weight-loss pill to be made widely available over the counter. Public Citizen has a strong track record of identifying dangerous drugs well before federal regulators take action to ban or put warnings on these drugs. For example, Public Citizen warned consumers about the dangers of Vioxx, Ephedra, Bextra, Rezulin, Baycol, Propulsid and many other drugs years before the drugs were pulled from the market. Public Citizen, representing over 100,000 consumers in this petition, has moved forward with the petition based on research that shows people taking Orlistat have a significant risk of developing aberrant crypt foci. Aberrant crypt foci has been found to be a precursor to colon cancer.

Orlistat side effects has also been determined to be associated with higher risks of developing breast cancer. Data from Hoffman La-Roche's clinical studies showed that It accelerated the development of breast cancer in women over 45 years of age or older when given the medication orally at a dose of 120 milligrams three times per day. This data initially gave the FDA concern and it held off on approving the drug. In the seven randomized, controlled clinical trials, there were 10 cases of breast cancer in the treated group with only one in the control group. The relative risk of getting breast cancer while taking Orlistat (compared to those taking a placebo) was calculated several times by both the FDA and the sponsor and found to vary between 4 and 7 fold, depending on the analysis. These results caused the FDA Medical Officer to rescind his original approval. However, the FDA recommended that the warning labels contain information related to this risk, also asked for post marketing surveys to be conducted. No such warnings were included in the products labels, and to the present date no post marketing surveys have been performed.

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