Orlistat, the active ingredient in the over-the-counter weight loss pill Alli, and prescription strength Xenical, is currently under investigation by the FDA. This comes after 32 reports of liver damage in people taking these drugs between 1999 and 2008. Of these 32 cases, 27 people were hospitalized with 6 experiencing liver failure.
The makers of Alli and Xenical are currently denying that these drugs are responsible for the reported cases of liver disease. This statement comes despite the fact that potential liver injury is listed as a possible side effect of Xenical. Still, they claim that the safety of these drugs have been tested in 100 clinical studies consisting of over 30,000 people. They go on to state that “people who are overweight and obese are predisposed to liver-related disorders” and therefore, a direct relationship between Orlistat and liver failure cannot be established.
The Liver
The liver is responsible for more than 500 vital functions. Although very complex, these functions can be summarized as the metabolism of nutrients, drugs, and toxins, and the regulation of blood particles.
When food, drugs, or toxins (i.e. alcohol) are ingested, they must pass through the liver to be metabolized. After they are metabolized, they are transported to other parts of the body for use. Some drugs, prescription and non-prescription, are toxic to the liver, especially in high doses, and can cause damage to liver cells. Overtime, increased damage to liver cells result in an overall decrease in liver function, and potential for liver failure.
Aside from drugs damaging liver cells, diet can also play a role. Eating an excessive number of calories, especially from fat, can cause a condition know as “fatty liver.” Fatty liver can also result from poorly controlled diabetes, alcohol abuse, and/or high triglycerides. Fat accumulation in the liver can lead to liver inflammation (hepatitis) and/or hardening of the liver (cirrhosis). Either way, liver function is decreased, and symptoms can occur.
Symptoms of liver damage are many, and include the following:br>
People who are taking any form of Orlistat, and experience any of these symptoms, are advised to seek immediate medical attention.
The Truth about Orlisat
Unfortunately, the truth about Orlistat is not clear cut. It is true that being over weight or obese are risk factors that can lead to liver failure. Since the majority of people who take Orlistat tend to fall into these 2 categories, it is difficult to make a direct relationship between Orlistat and the cases of liver damage. Without a direct link, Xenical and Alli will continue to be marketed during the ongoing FDA investigation.
What to Do
Right now, the FDA recommends for people to continue taking Orlistat as medically directed. If symptoms occur, usage should be stopped immediately, and medical attention sought. Still, it is important to know all the facts, so research both the drug and your own family medical history. Then weigh-out the potential risks and benefits before making your final decision.
References
Beers MH, Berkow R. The Merck Manual of Diagnosis and Therapy. 17th Edition: 1999. Whitehouse Station, NJ: Merck Research Laboratories.
FDA News Release (August 24, 2009). FDA issues early communication about ongoing safey review of weight loss drug Orlistat. FDA.gov. Retrieved September 10, 2009. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm180057.htm
Perrone, Matthew. FDA Probes Liver Damage with Weight Loss Pill Alli. 2009. abcnews.com. Retrieved Sept 10, 2009. http://abcnews.go.com/Health/Drugs/wireStory?id=8401977
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