What should I know about the safety
of LOTRONEX®?

LOTRONEX can cause serious side effects

LOTRONEX has been shown to help some women improve control over their symptoms of severe IBS with diarrhea. Still, like many medicines, there are some serious side effects that sometimes happen to women who take LOTRONEX. It’s important to talk to your doctor about the benefits and the risks of any medication you are thinking about taking, including LOTRONEX.

Some patients have reported serious intestinal side effects while taking LOTRONEX. These include:

  • Serious complications of constipation (CoC)
    • Women taking either LOTRONEX or placebo (sugar pills) during clinical trials developed CoC in about 1/1000 cases
    • There was no relationship between the dosage of LOTRONEX and the chances of getting CoC
  • Ischemic colitis (IC), which is the name for a condition in which a person has reduced blood flow to the colon
    • In clinical trials for LOTRONEX, about 2/1000 women in the first 3 months and 3/1000 women in the first 6 months got IC
    • One woman on placebo (sugar pills) got IC as well

These can happen suddenly and may lead to a hospital stay and, in rare cases, blood transfusions, surgery, and death.

To lower your chances of getting serious complications of constipation or ischemic colitis, stop taking LOTRONEX and call your doctor right away if:

  • You have problems clearing your bowels (constipation)
  • You get new or worsening pain in your stomach area
  • You find blood in your stools
  • If you are constipated, do not start taking LOTRONEX
  • If your constipation does not get better after stopping LOTRONEX, call your doctor again
  • If you stopped taking LOTRONEX, do not start taking LOTRONEX again unless your doctor tells you to do so

People who are older, who are weak from sickness, or who take other constipating medicines may be more likely to have serious complications of constipation with LOTRONEX.

While LOTRONEX may provide relief for some women who have severe IBS-D, it is not right for everyone.

How many people have taken LOTRONEX?

Between November 2002 and June 2008:

  • About 30,000 people used LOTRONEX
  • Find out if LOTRONEX®
    is right for you

Before using LOTRONEX® for the first time, you should:
  • Understand that LOTRONEX has serious risks for some people.
  • Read and follow the directions in the Medication Guide.
INDICATIONS AND USAGE

LOTRONEX is a medicine only for some women with severe irritable bowel syndrome (IBS) whose main problem is diarrhea; whose IBS symptoms have lasted 6 months or longer and have not been helped enough by other treatments.

You can tell if your IBS is severe if at least 1 of these is true: you have lots of painful stomach cramps or bloating; you often cannot control the need to have a bowel movement, or you have “accidents” where your underwear gets dirty from diarrhea or bowel movements; you cannot lead a normal home or work life because you need to be near a bathroom.

Enough testing has not been done to confirm if LOTRONEX works in men or children under 18.

IMPORTANT SAFETY INFORMATION

LOTRONEX can cause serious side effects:

Some patients have reported serious intestinal side effects while taking LOTRONEX. These include:

  • Serious complications of constipation
  • Reduced blood flow to the bowel (ischemic colitis)

These can happen suddenly and may lead to a hospital stay and, in rare cases, blood transfusions, surgery, and death.

Stop taking LOTRONEX and call your doctor right away if you have problems clearing your bowels (are constipated) or get new or worsening pain in your stomach area or blood in your stools. If your constipation does not get better after stopping LOTRONEX, call your doctor again. If you stopped taking LOTRONEX, do not start taking LOTRONEX again unless your doctor tells you to do so.

People who are older, who are weak from sickness, or who take other constipating medicines may be more likely to have serious complications of constipation with LOTRONEX.

Who should not take LOTRONEX?

Do not take LOTRONEX if any of these apply to you:

  • Your main IBS problem is constipation or you are constipated most of the time.
  • You have had a bad problem from constipation. If you are constipated now, do not start taking LOTRONEX.
  • You have had bad bowel blockages.
  • You have had blood flow problems to your bowels, such as ischemic colitis.
  • You have had blood clots.
  • You have had Crohn’s disease, sores in the colon (ulcerative colitis), swelling of a sac in the intestine (diverticulitis), or severe liver disease.
  • You do not understand the Medication Guide or are not willing to follow it.
  • You are taking a medicine called LUVOX® (fluvoxamine).
What are the possible side effects of LOTRONEX?

The most common side effects of LOTRONEX are constipation, stomach pain and nausea. Some patients have developed serious bowel side effects while taking LOTRONEX. These are not all the possible side effects of LOTRONEX. Your doctor or pharmacist can give you a more complete list. Call your doctor for medical advice about side effects.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.