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FDA Announces Investigation Into Reports That Weight-Loss Drug Caused Liver Failure

By August 28, 2009July 17th, 2019Drug Safety

The U.S. Food and Drug Administration announced Aug. 24 that it is looking into safety problems with a popular weight-loss drug. According to the Los Angeles Times, the agency has received at least 32 reports of liver problems with orlistat, sold over the counter as Alli and as the prescription drug Xenical. The FDA is analyzing data included in those reports, as well as data from manufacturers, and said it would announce results as soon as the study is complete. The agency is not taking any enforcement action yet and did not tell patients to stop taking the drugs, but it did tell them to talk to their doctors if they see signs of liver problems.
The FDA’s press release said the agency received the 32 reports of problems with orlistat between 1999 and October of 2008. Of those patients, 27 had to be hospitalized, and six suffered liver failure. The most common liver problems reported to the FDA as side effects of orlistat were weakness, abdominal pain and jaundice, which is a yellowing of the eyes and skin. Other signs of liver problems include fatigue, fever, brown urine, pale stools, nausea and vomiting, itching and loss of appetite.
Orlistat helps patients lose weight by stopping the digestive tract from absorbing about 25% of the fat they eat. The 2007 approval of the over-the-counter version, Alli, was widely anticipated by the weight-loss community because of its apparent effectiveness. However, Alli was not without side effects even before the recent reports of liver problems. In fact, the drug is somewhat famous for having an embarrassing, though minor, side effect — fecal incontinence, or loss of control over the bowels, especially in people who eat too much fat. Alli’s manufacturer, GlaxoSmithKline, went so far as to tell users to carry a change of clothes for the first few days they use the drug, in case of an “accident.” Long-term studies have also linked orlistat to cancer, although not definitively.
As a dangerous drug lawyer, I am much more concerned about these new reports of possible liver damage than I am about fecal incontinence. Liver problems can lead to liver failure, and liver failure is a serious, life-changing health problem with a high chance of death. People with liver failure require hospitalization, close monitoring, special diets and, in cases where the organ cannot recover, liver transplants. This is an unacceptable risk to exchange for the opportunity to lose a few pounds. Orlistat is very popular, with more than 22 million users worldwide. That means that even if only a fraction of those users develop serious liver problems, thousands of people could still develop life-threatening illnesses or lifelong, disabling organ damage — all to lose a few pounds.

Based in St. Louis, the Lowe Law Firm represents people around the United States who were seriously hurt by dangerous prescription drugs like this. Drug makers, like all manufacturers of consumer products, are strictly liable for the injuries their products cause, even if they didn’t know in advance about the problem. When they don’t meet their legal duty to offer a safe product, or at least warn their patients, our pharmaceutical liability attorneys help patients who were hurt as a result hold the companies responsible for their actions. A defective medication lawsuit cannot reverse the injury, unfortunately, but it can help patients recover the money they need to deal with it, including the cost of past and future medical treatments as well as other costs and compensation for their personal losses.
If you have developed a serious health problem you believe is related to orlistat or any other prescription drug and you’d like to know more, you should talk to the Lowe Law Firm. To set up a completely free, confidential evaluation of your case, please contact us through the Internet or call 1-877-678-3400 toll-free from anywhere in the U.S.