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.