Lotronex Side Effects and Lawsuits


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lotronex, which has also been marketed under the brand name Alosetron, is a medication intended for use by women only in the control of chronic diarrhea related to irritable bowel syndrome.  The marketers of the Lotronex, Prometheus Laboratories in San Diego, were banned from providing Lotronex to U.S. markets in 2000 by the FDA in light of numerous claims and findings relating use of Lotronex to serious gastrointestinal conditions.  However, in 2002, the FDA reversed their initial decision and in turn, allowed Lotronex back into the U.S. marketplace under further restrictions.  The FDA’s decision to re-allow Lotronex, which was used to treat non-lethal conditions, but possessed potentially lethal consequences, has been linked to confidential agreements between the funding for FDA projects and the makers of the drug at the time, which was GSK.  Clearly, the actions of both the FDA and the marketers of the drug violate numerous drug liability laws, and in turn, legal actions against both entities have been initiated by patients.

Risks and Symptoms of Lotronex

Alarmingly, despite the well-known dangers associated with Lotronex, the drug is still available in the U.S. markets, albeit with strict warnings and required patient-physician signature of understanding about these risks.  The FDA claims the drug is available only for female IBS patients who have not responded to any other form of treatment. 

The risks associated with the drug before the 2000-ban and still existing today are numerous and alarming.  Studies have shown that one in one thousand patients suffer potentially life-threatening problems, including constipation requiring surgical intervention, colonic ischemia, and constipation related perforation of the bowels.  The drug has also been linked to various forms of toxicity stemming from impaction of the digestive tract and colon, while taking Lotronex.  Deaths have been reported resulting from gastrointestinal issues compounded by Lotronex use.

Lotronex Claims and Lawsuits

At one time, Lotronex was banned from the U.S. markets, however, under questionable conditions; the FDA permitted the drug’s re-entry into the market, which was the first action of this kind.  Lotronex legal action resulting from liability claims are currently being considered for class action status in the courts, however, individual claims for drug liability regarding Lotronex have already occurred.  The original marketer of the drug, GSK, has since sold their interest in Lotronex to Prometheus Laboratories in San Diego in 2007.

Legal Help from a Lawyer

Claims against Lotronex makers and marketers, as well as potentially the FDA involvement in the re-entry of the drug to the market, are being fielded now by attorney.  A true assessment of the number of claims against the drug is unknown; however, a clear indication of liability exists with patients exhibiting damages clearly related to Lotronex use.  If you have suffered medical complications or required surgery following or during the use of Lotronex, your claims case should be heard by an attorney.

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