Zelnorm
Zelnorm (tegaserod maleate) is a drug used to treat Irritable Bowel syndrome. It was withdrawn March 2007, due to high rates of heart attacks, strokes, and unstable angina. Thirteen treated patients had life-threatening cardiovascular adverse effects. It has also been linked with severe diarrhea and ischemic colitis. In July 2007 it was back under Investigational New Drug (IND), in which the drug becomes available to patients who are seriously ill while the drug is being tested.
Only healthy women under the age of 55 can be eligible to receive the drug, who have IBS or chronic idiopathic constipation. Also, a patient is eligible if he/she has not had any problems with the drug before or did not respond to other medicines. The drug is made available at no cost to the user. This reduces the chance of the drug causing heart attacks and strokes. Therefore, it may be resubmitted in to the FDA and only be approved for healthy women under 55.
As of April 2008, the company Normis, which produces Zelnorm, has decided to shut down the program and making Zelnorm unavailable for anyone, regardless of situation. It took eight months for the company to decide to remove the drug from the public? This means that within those eight months, who knows how many people have taken this drug and risked their life? The company has made this info available on their website.
