What should I know about the safety
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