Zelnorm Recall: People with IBS-Constipation Protest FDA Zelnorm Recall

Zelnorm is the only prescription drug on the market for irritable bowel syndrome (IBS-C) with constipation. IBS either causes constipation or diarrhea or sometimes both. While other drugs may be prescribed IBS-diarrhea, Zelnorm is the only prescription drug for IBS-constipation.

Now 20,000 members of an IBS self-help group are protesting by calling the Food & Drug Administration about reversing the Zelnorm Recall. Irritable bowel syndrome affects as many as 20 percent of the adult population in the United States.

As more medicines pose life threatening side effects, more medicines are being pulled from the marketplace. Life threatening Zelnorm side effects include chest pains, heart attacks, strokes and ovarian cysts and ischemic colitis. These life threatening side effects may only affect a small percentage of patients but the Zelnorm side effects are too severe to ignore.
 
Some patients will start taking fiber supplements and laxatives and perhaps probiotics. Doctors are recommending that some patients try other medications that aren't specifically approved for IBS, but that can be prescribed off-label.  Patients should proceed with caution regarding this approach as these off-label drugs may have many unwanted side effects.

In 2002 Lotronex, a drug used to threat IBS-diarrhea was removed from the market because of public health and safety concerns. Again IBS-diarrhea patients protested and the FDA allowed Lotronex back on the market but the drug carries severe warnings with the labeling.

The FDA may consider the same route for Zelnorm pending further testing and restrictions.

Some patients who take Zelnorm may consider buying the drug from overseas sources but a prescription will still required.  According to Novartis about 500,000 Americans were taking the Zelnorm before the sales suspension. Zelnorm sales in the United States were $488 million last year, making up most of its global sales of $561 million. In the United States, the drug costs about $180 for one month's supply.