Find Information About:

Drugs & Supplements

Get information and reviews on prescription drugs, over-the-counter medications, vitamins, and supplements. Search by name or medical condition.

Pill Identifier

Pill Identifier

Having trouble identifying your pills?

Enter the shape, color, or imprint of your prescription or OTC drug. Our pill identification tool will display pictures that you can compare to your pill.

Get Started

My Medicine

Save your medicine, check interactions, sign up for FDA alerts, create family profiles and more.

Get Started

WebMD Health Experts and Community

Talk to health experts and other people like you in WebMD's Communities. It's a safe forum where you can create or participate in support groups and discussions about health topics that interest you.

  • Second Opinion

    Second Opinion

    Read expert perspectives on popular health topics.

  • Community


    Connect with people like you, and get expert guidance on living a healthy life.

Got a health question? Get answers provided by leading organizations, doctors, and experts.

Get Answers

Sign up to receive WebMD's award-winning content delivered to your inbox.

Sign Up

Irritable Bowel Syndrome (IBS) Health Center

Font Size

IBS Drug Withdrawn After Less Than a Year on the Market


As for the constipation that sometimes develops while patients take the drug, "We feel that it is totally manageable," Kent says. Physicians are perfectly familiar with that condition, and there were only a few cases in which patients required surgery, he tells WebMD.

The FDA has maintained that while Lotronex's relationship to ischemic colitis may not be understood, there is ample evidence to show that the drug is at least being improperly used to treat patients who do not stand to benefit from the medication. In effect, according to the FDA, that means a number of patients are being exposed to unnecessary risk of both ischemic colitis and constipation. Clinical trials have shown that while Lotronex may greatly benefit women with diarrhea-predominant IBS, but the drug also has been shown to have little to no benefit for men, as well as for women whose predominant symptom is constipation, the agency explains.

There also are strong signals for a possible risk, some consumer groups say. According to Public Citizen, a prominent consumer watchdog group, the drug has been linked to at least 54 cases of ischemic colitis as of October, making it "irresponsible for Glaxo Wellcome and for the FDA to allow this doomed drug to stay on the market any longer." Public Citizen, among other consumer groups, has called for the drug's withdrawal since August.

But while Lotronex's association with ischemic colitis might now never be fully understood, the withdrawal is sure to once again raise the issue of whether U.S. health authorities are moving too quickly in approving new drugs. In the span of just two years, the agency has called for the withdrawal of about six drugs, raising questions about the merits of the system that brought these drugs to the public in the first place.

Critics say the withdrawals prove that the agency has lowered its safety standards in approving drugs. But agency supporters say these actions are inevitable because some adverse events, such as ischemic colitis, are rarely caught during the clinical trials conducted to support a drug's approval.

Today on WebMD

filling glass of water from faucet
Prevention strategies to try.
stomach ache
From symptoms to treatments.
Causes, symptoms, and treatments.
worried mature woman
Are they related?
IBS Trigger Foods
Supplements for IBS What Works
IBS Symptoms Quiz
digestive health
gluten free diet
digestive myths
what causes diarrhea
top foods for probiotics