FDA approves new drug to treat constipation from cancer pain drugs

Posted by Kate Murphy on April 26th, 2008

The FDA has approved Relistor to treat constipation caused by drugs used to treat pain in patients with cancer and other advanced illness who are receiving palliative care. 

Morphine and similar opiate drugs slow bowel activity and lead to constipation which can be very difficult to manage.  The discomfort of constipation often leads patients to reduce pain medicines and suffer unnecessary pain.

Relistor (methylnaltrexone bromide) is an injection that is given under the skin and which blocks opiate action on the intestinal tract without interfering with pain relief. 

Approval was based on two randomized, double-blinded clinical trials in which patients on opiate drugs to control pain were given Relistor or a placebo.  In both studies about 60 percent of patients on Relistor had a bowel movement within 4 hours of treatment compared to about 15% of those getting a placebo.

Side effects include abdominal pain, gas, nausea, dizziness, and possible diarrhea.  Patients and their caregivers are cautioned that Relistor works quickly to produce a bowel movement to they need to be close to a bathroom.  One third of patients in the clinical trials had a bowel movement within 30 minutes of their Relistor injection.

Most patients in the trials had advanced cancer but some had chronic obstructive pulmonary disease, heart failure, Alzheimer’s disease, or AIDS.

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