Even in clinical trials, Lotronex displayed a tendency towards causing ischemic colitis in patients. From the February in which Lotronex was approved until June, the FDA received seven reports of serious complications of constipation leading to hospitalization. Surgery was required to relieve some cases of extreme Lotronex constipation. Lotronex Medication Guides were issued under regulations that became effective in 1999 when Lotronex patients ended up in hospitalization and requiring surgical procedures for constipation. Since Lotronex is a drug used to treat diarrhea, these surgeries were obviously not necessary to treat conditions held before taking the drug.
Despite the FDA's issuing of this safety information about Lotronex, patients kept filing severe adverse event reports of ischemic colitis, complications of constipation, death reports, and complications requiring blood transfusions. The FDA recalled Lotronex on November 2000, just nine months after approval.
In 2002, the FDA announced the approval of a supplemental New Drug Application that allows restricted marketing of Lotronex to treat only women with severe diarrhea-predominant irritable bowel syndrom. The approval of Lotronex includes a risk management program to ensure patients and physicians are fully informed of risks and possible benefits of Lotronex. Patients using Lotronex must sign a contract with their doctors stating that they understand the risk of serious constipation that could result in surgery, blood transfusion, or death.
These restrictions are very tight because of the history of tragedies involving Lotronex and its potential to cause unusual, very painful death by constipation. Because of this it is imperative that Lotronex not be bought over the internet. The system through which patients sign a Lotronex contract with their doctor assures that everybody involved in the transaction is educated on all the dangers and benefits involved and prepared to accept responsibility for the consequences.
Please contact a lawyer if you have taken Lotronex during the time when it enjoyed unrestricted access to the market, between 1999-2000. Also contact a lawyer if you are currently taking Lotronex and have not signed a contract with your doctor, or feel that your physician is administering the drug improperly.
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