Litigation Surrounding Lotronex
What is Lotronex?
The drug was approved for use in February 2000 to control symptoms of irritable bowel syndrome (IBS). It is intended for women who suffer from chronic IBS symptoms.
What were the major problems associated with Lotronex?
The FDA was concerned of effects from the drug including reported cases of ischemic colitis, obstructed and ruptured bowels from complications of constipation, and intestinal damage. Despite clinical trial incidence these severe side effects, Glaxco Wellcome worked with the FDA to market the drug.
Why was Lotronex removed from the market?
The drug was pulled off the market from Glaxco Wellcome, its manufacturer, on November 28, 2000. There have been around 60 reports of ischemic colitis and four deaths resulting from Lotronex use from March 2000. The FDA reviewed 70 cases as of November 10, 2000. 49 cases resulted in ischemic colitis and 21 resulted in severe constipation. 10 of the patients needed surgery and 3 resulted in death. Through June 1, 2000, the FDA continued to receive reports of complications of severe constipation and ischemic colitis. Glaxco Wellcome ignored the FDA request to put a black box label on their product and claimed it would deter doctors from prescribing the drug. From the numerous reports, the FDA had no choice but to suggest a marketing withdrawal of the drug, only 9 months after approval.
Lawsuit involving Lotronex
On December 21, 2000, Edgar & Snyder and Associates and Ludwig & Beatty filed suit against Glaxco Wellcome. This suit was among the first filed against the manufacturers of Lotronex. The woman participated in a clinical study in March 2000. The participant was not warned by the manufacturer of the risk of ischemic colitis and severe constipation in her consent and information form. She discontinued taking the drug in March, however, in April she was awakened with severe abdominal pain. Surgery was necessary to remove her colon due to complications from ischemic colitis.
