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Drug Treatment in IBS - The Lesson of Alosteron (Lotronex)
Alosetron (Lotronex) was approved for marketing by the FDA in February, 2000, but was withdrawn from the market in November, 2000, because of serious, life-threatening, gastrointestinal side effects. In June 2002, it was approved again by the FDA for marketing but in a restricted manner as part of a drug company-sponsored program for managing the risks associated with treatment. Use of alosetron is allowed only among women with severe, diarrhea-predominant, irritable bowel syndrome (IBS) who have failed to respond to conventional treatment for IBS.
This article was written at the time alosteron was withdrawn by the FDA.
--Medical Editors, MedicineNet.com
The use of any drug, be it prescription,
over-the-counter (OTC), or herbal, requires thought. The most important
considerations are the benefits and the risks of taking the drug. If the
potential benefit doesn't outweigh the potential risk, then the drug should not
be taken. With respect to ethical drugs (prescription and OTC drugs), benefit is
easier to determine than risk because drug studies are required in order for the
drugs to be approved by the Federal Drug Administration (FDA) for marketing.
These studies tell us how often the drug works and how well it works. The same
studies usually tell us how often side effects (risk) occur. Unfortunately, unless many thousands of patients
participate in the studies (which is almost never the case), uncommon side
effects will not be recognized until the drug is approved and marketed to
thousands of patients.
Last Editorial Review: 3/25/2002
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