Lotronex is a drug that is marketed to women in the United States to help them control the chronic diarrhea that they experience as a result of irritable bowel syndrome. The drug has also been sold via the brand name Alosetron. Prometheus Laboratories located in San Diego both markets and manufacturers Lotronex.
In 2000, the United States Food and Drug Administration banned Prometheus from selling Lotronex within the United States as a result of a number of findings and claims where Lotronex was tied to severe conditions of the gastro and intestinal tract. However, the decision was reversed by the FDA in 2002 and Lotronex was then allowed to return to the country with a number of restrictions in place.
Latronex’s Return to the American Market
The decision by the FDA to allow Lotronex back into the country, a drug that was used to help with conditions that were not lethal but which was capable of producing lethal consequences in certain people, has been attributed to Glaxo Smith Kline, who made the drug at the time, and provided substantial amounts of funding for projects by the FDA. Because of this, it seems there have been a number of confidential dealings involving funding that may have allowed the drug back into the country despite the various risks associated with its use. Proponents of the drug and its entrance back into the United States market claim that it is clear that the actions of the drug’s manufacturers, as well as those of the FDA, are in violation of a number of liability laws related to drugs within the United States. As a result, it may come as no surprise that many patients have chosen to initiate legal action against both parties.
Present Latronex Warnings and Restrictions
Despite the alarming fact linking a number of well known risks in conjunction with using Lotronex, the drug can currently be purchased in stores throughout the United States. However, the drug is now sold with a number of warnings located on the packaging. As another standard of warning and comprehension concerning possible side effects, it is now required that both the physician and patient consuming the drug sign a release indicating that they have understood the risks associated with using the drug.
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