Relistor OK'd for those on continuous opioids
The Food and Drug Administration (FDA) has approved Relistor (methylnaltrexone bromide) to help restore bowel function in patients with late-stage, advanced illness who are receiving opioids on a continuous basis to help alleviate their pain.
These patients include those with a diagnosis of incurable cancer, end-stage chronic obstructive pulmonary disease (COPD) from emphysema, heart failure, Alzheimer's disease with dementia, HIV/AIDS, or other advanced illnesses.
Opioids can interfere with normal bowel elimination function by relaxing the intestinal smooth muscles and preventing them from contracting and pushing out waste products. Methylnaltrexone bromide acts by blocking opioid entrance into the cells, thus allowing the bowels to continue to function normally.
Methylnaltrexone bromide is an injectable medication. It can be administered as needed, but not to exceed one dose in a 24-hour period. The recommended starting schedule is one dose every other day as needed for patients with late-stage advanced illness. Methylnaltrexone bromide is not recommended for patients with known or suspected intestinal obstructions.
Common side effects include abdominal pain, gas, nausea, dizziness, and diarrhea. If severe diarrhea, vomiting, nausea, or abdominal pain occurs while taking methylnaltrexone bromide, patients should discontinue use of the medication in consultation with their health care professional.
Two studies show safety
The safety and effectiveness of the drug was demonstrated in clinical studies conducted by the sponsors. The two randomized, double-blind placebo-controlled studies involving a total of 287 participants were conducted over four months. The median age of the study participants was 68 years, and 51% of the participants were women. In both studies, all patients had advanced late-stage illnesses with a life expectancy of less than six months. Prior to treatment with methylnaltrexone bromide, participants had either fewer than three bowel movements in the week prior to treatment or no bowel movement for more than two days. Patients who were treated with methylnaltrexone bromide had a significantly higher rate of elimination than those receiving placebo. The safety and effectiveness of methylnaltrexone bromide have not been studied in pediatric populations.
Methylnaltrexone bromide is manufactured by Wyeth Pharmaceuticals, Philadelphia, and Progenics Pharmaceuticals, Tarrytown, NY.
The Food and Drug Administration (FDA) has approved Relistor (methylnaltrexone bromide) to help restore bowel function in patients with late-stage, advanced illness who are receiving opioids on a continuous basis to help alleviate their pain.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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