Lotronex Lawsuits

Lotronex was approved on February 9, 2000 by the FDA and was closely monitored from its arrival onto the market. Even before Lotronex received it's approval four cases of ischemic colitis was observed during clinical studies. From the February Lotronex approval until June, the FDA had received seven post-marketing reports of serious complications of constipation, leading to hospitalization and requiring surgery in some instances.

The FDA later updated the healthcare professional labels for Lotronex and had the Lotronex manufacturer issue Medication Guides to patients. The Lotronex Medication Guides were the first ones issued under regulations that became effective in 1999. Due to Lotronex patients ending up in hospitalization or requiring surgical procedures for things not usually associated to conditions Lotronex is intended for, the Medication Guide allowed patients to become better aware of the serious risks of Lotronex.

Despite the FDA's safety issued information regarding Lotronex, the agency continued receiving severe adverse event reports of ischemic colitis and complication of constipation, as well as more death reports and serious complications requiring blood transfusions or surgery. The FDA recalled Lotronex on November 28, 2000, just 9 months after approval.

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