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: Tennessee Law BlogPopular Alli Weight Loss Pill Gets New FDA Warning Label
Many of us have seen commercials about the over the counter weight loss drug, Alli. Some of us have maybe even tried it or are still taking it. The Alli pill and program is supposed to change the way people think and feel about eating and dieting. It is has personalized plans and steps for each person and it is supposed to make burning calories even easier. Many of us across the country and even right here in Tennessee know about this pill, but many of us may not know the new problems it seems to be causing.
As of today, May 27, 2010, the Food and Drug Administration has revised the label for this drug so that includes new safety information about rare cases of severe liver injuries and damages. The FDA has not determined if Alli is actually causing the liver problems but wants the public to be aware because a condition like this is very serious.
This new warning is based on a complete review by the FDA of all data available from preclinical and clinical trials, as well as post marketing studies and the drug usage from April 1999 to August 7, 2009. The FDA has also identified thirteen post marketing cases of severe liver injury, twelve of them foreign cases involving another weight loss drug known as Xenical and one case involving Alli. In three of these cases, people needed liver transplants and two people died.
Even though cases like these are rare with this drug, it is unfortunate and sad when things like this happen, across the country and even right here in Tennessee. The FDA reported that about 40 million people worldwide use drugs like Xenical or Alli, which means that some of these cases could have been a friend or family member.
Full post as published by Tennessee Law Blog on May 27, 2010 (boomark / email).
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