Home > Online Clinic News > Orlistat Cleared As Safe by EMA

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by Robert MacKay, Thursday, March 1, 2012 | Categories: Xenical

The European Medicines Agency (EMA) reassures that the benefits of Orlistat, a weight loss treatment for obesity, outweigh the risks associated with the drug. A review, which was requested by the European Commission, was carried out in August and has abated fears over the drug’s potentially harmful side effects. Orlistat is the key ingredient in Xenical and is also the key ingredient of the lower dose version, Alli.

Last September a review commenced amidst concerns over the drug’s potentially harmful effect on the liver. There have been cases where those who were taking the drug experienced liver damage however; there have not been enough cases reported since Orlistat was introduced to the market to prove the product should be taken off the shelves. Furthermore, other risk factors could have contributed to liver toxicity and damage in individual cases, according to the agency. Out of the approximately 50 million people who take and have taken Orlistat in the past, the numbers who have experienced such side effects is insignificant compared with the number of people taking it and does therefore, not require the discontinuation of the drug, especially at a time when no other licensed weight loss products are available for obesity treatment. Only 21 cases of severe liver toxicity were reported between 1997 and 2011 and in many cases it was likely that there were other root causes for the illness. Obesity itself is known to be associated with liver disease according to the EMA.

The agency reviewed all of the data available on the risk of liver damage and Orlistat across various studies and reports that have been carried out over the years. They concluded that there was no evidence to support the increased risk associated with taking Xenical. Furthermore, none of the cases where liver damage had occurred were similar; there was no correlation between the types of damage reported. There was also little evidence to prove that the drug had directly caused any of the injuries reported.

The latest news is that the EMA has completed its review and is still certain that the benefits of taking Orlistat outweigh the risks, putting fears over the drug’s safety profile at bay.

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