FDA ISSUES Warning About IBS Drug Zelnorm

[Guest guest]

Hi Gang,

I don't know if anyone is on this medicine, but they just issued A

Warning...

Ann-Marie

FDA Issues Warning About IBS Drug Zelnorm

Drug Associated With Serious Diarrhea, Reduced Blood Flow to Intestines

By , MD

WebMD Medical News Reviewed By Charlotte Grayson, MD

on Wednesday, April 28, 2004

April, 28 2004 -- The FDA today issued a warning associated with the

irritable bowel syndrome (IBS) drug Zelnorm.

The FDA says Zelnorm has been associated with serious cases of diarrhea as

well as instances of ischemic colitis -- a medical condition where blood flow is

reduced to the intestines.

Zelnorm is a prescription medication for the short-term treatment of women

with IBS whose primary bowel symptom is constipation. The FDA says it's adding

this new drug information to ensure doctors and patients have the most current

and complete information available when prescribing and taking Zelnorm.

The specific revisions include:

a.. A new warning about the serious consequences of diarrhea associated

with the medication

b.. A new precaution about ischemic colitis and other forms of reduced

blood flow to the intestines

c.. Changes to side effects information section describing information

gathered since the drug was approved in July 2002

The New Warning

In the new warning, the FDA states that serious consequences of diarrhea,

including significant loss of fluid, low blood pressure, and episodes of passing

out, have been reported in the clinical studies and during marketed use of

Zelnorm. In some cases, these complications have required hospitalization for

rehydration.

The FDA recommends that Zelnorm be discontinued immediately in patients

who develop low blood pressure or passing out spells. Zelnorm should not be used

in patients who are currently experiencing or frequently experience diarrhea.

The New Precaution

The FDA has also issued a precaution regarding the risk of reduced blood

flow to the intestines, which may lead to inflammation of the intestines, called

ischemic colitis.

In the new precaution, the FDA states that ischemic colitis and other,

similar conditions have been reported in patients taking Zelnorm. Although this

association has been observed, the FDA says that Zelnorm has not been proven to

cause this effect. The FDA adds that clinical trials comparing Zelnorm to

placebo in 7,000 patients for three months showed no cases of these events. This

suggests the rate of such events is low, according to the FDA.

The agency says Zelnorm should be discontinued immediately in patients who

develop symptoms of ischemic colitis, such as rectal bleeding, bloody diarrhea,

or new or worsening abdominal pain. Treatment with Zelnorm should not be resumed

in patients who develop findings consistent with ischemic colitis.

The FDA advises patients who get new or increased stomach pain or blood in

their stools to stop taking Zelnorm right away and to immediately contact their

doctor to determine if they may have a serious problem. In addition, the FDA

advises patients to stop taking Zelnorm and to call a doctor right away if they

experience diarrhea that leads to lightheadedness, dizziness, or fainting.

Zelnorm is the only FDA-approved prescription drug for the short-term

treatment of women with irritable bowel syndrome whose primary bowel symptom is

constipation.

Zelnorm increases the movement of stools through the bowels. Zelnorm does

not cure IBS, nor does it treat the type of IBS where diarrhea is the

predominant symptom. Zelnorm reduces pain and discomfort in the abdominal area

and reduces bloating and constipation. The safety and effectiveness of Zelnorm

in men have not been established.

--------------------------------------------------------------------------

Novartis, the maker of Zelnorm, is a WebMD sponsor.

SOURCE: FDA.