Lotronex Class Action Lawsuits Lotronex Class Action Lawsuits Information

Lotronex Class Action Lawsuits
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Lotronex Class Action Lawsuits Information

Lotronex was FDA approved on February 9, 2000 and was closely monitored from its arrival onto the market. Even before Lotronex received 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 labeling for Lotronex and had 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.

Lotronex Side Effects

Reports of intestinal damage resulting from ischemic colitis, severely obstructed or ruptured bowels, and death occurred because of Lotronex use, launching various Lotronex class actions.

More Lotronex Information

Lotronex alosetron is an irritable bowel drug prescribed to female patients that was linked to deadly side effects. After entering the market, the risk of dangerous and serious Lotronex alosetron side effects were so great that it was taken off the market nine months later. The Lotronex alosetron adverse effects reported included intestinal damage resulting from ischemic colitis, severely obstructed or ruptured bowels, and death.

The FDA has announced that restricted marketing of Lotronex alosetron can occur. The June 2002 Lotronex alosetron announcement was the first time since the Lotronex recall that the drug will be allowed, but on a restricted distribution and use program. The FDA has developed safety measures to better inform physicians and patients of the potential deadly risks that can occur with Lotronex alosetron use.

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