Drug Criteria & Outcomes: New FDA Approvals
June 1, 2008 3 minutes read
Drug Criteria & Outcomes
The 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.
Opioids are often prescribed on a continuous basis for patients with late-stage, advanced illness to help alleviate pain. This includes patients 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.
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 a four-month period. 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 less 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 Inc., Philadelphia, PA, and Progenics Pharmaceuticals, Tarrytown, NY.
Cimzia® (certolizumab pegol) has received approval from the FDA for adults with moderate-to-severe Crohn's disease who have not responded to conventional therapies. This product was approved with a Medication Guide.
Crohn's disease is a chronic, inflammatory bowel disease that affects more than one million men and women worldwide. It has no cure and its cause is unknown. Crohn's can cause diarrhea, fever, rectal bleeding, malnutrition, narrowing of the intestinal tract, obstructions, abscesses, cramping, and abdominal pain. It also can lead to abnormal connections (fistulas) leading from the intestine to the skin or internal organs.
Patients treated with certolizumab pegol will receive an injection every two weeks for the first three injections. Once benefit has been established, certolizumab pegol should be given once every four weeks.
The most common side effects of certolizumab pegol are headache, upper respiratory infections, abdominal pain, injection site reactions, and nausea.
Patients taking certolizumab pegol are at increased risk for serious adverse effects, including serious infections that can lead to hospitalization or death. Because certolizumab pegol affects the immune system, it can lower the body's ability to fight infections, such as tuberculosis and other opportunistic infections. Certolizumab pegol is a blocker of tumor necrosis factor and may cause lymphomas (a form of cancer) and other malignancies. Although an increased risk of tumors was not seen in studies of certolizumab pegol, the modest size and relatively short duration of the controlled studies prevents any firm conclusion. Post-marketing studies and clinical trials will be required to obtain long-term safety data.
Patients taking certolizumab pegol should be educated about how to identify an infection and be instructed to contact their health care professional at the first sign of infection while on certolizumab pegol. In cases of serious infections, the drug should be discontinued immediately.
Certolizumab pegol is manufactured by UCB, Inc., Smyrna, GA.
The 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.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content