More Information on Zelnorm

In 2001, the FDA did not approve Zelnorm and its European equivalent turned the drug down not once, but twice. Initially meant for short-term treatment in women, it soon got the OK in long-term treatment for both women and men.

The drug has now been removed from the market due to the risk of  Zelnorm side effects.

Problems outweigh benefits
People taking Zelnorm have a high rate of stroke, heart attack and cardiac chest pain. Novartis performed a review of 29 studies of Zelnorm, which the FDA then assessed. The agency concluded that the potential Zelnorm problems outweigh its benefits.

Virtually all drugs have risks or side effects. Being tested, and judged to be safe and effective does not mean that a drug is harmless. Its risks may be known before FDA approval is given, or sometimes they show up later. In this case, in 2001, the consumer watchdog Public Citizen had urged the FDA not to give its approval to Zelnorm although the larger concern then was an elevated risk of women getting ovarian cysts.

Three years later, the FDA issued a warning about other potential side effects of Zelnorm after some patients developed ischemic colitis, rectal bleeding, bloody diarrhea or abdominal pain. This came about due to insufficient blood and oxygen reaching the intestines. Although there was no proven connection between Zelnorm and these symptoms, it was strong enough to merit a warning.

Defining irritable bowel syndrome
Doctors regard IBS as a functional bowel disorder, which means that although the bowels do not appear to function right, no structural abnormalities can be identified. Thus it is not easily diagnosed.

IBS is quite common, and women tend to have it far more than men. Its cause, however, is not clear. IBS sufferers appear to have sensitive colons that are disturbed by things like stress or caffeine. Treatment options are evolving as more research is done.