FDA approves new oral drug to relieve constipation from opioid painkillers
Amitiza (lubiprostone) has already been approved in the United States for other conditions, such as constipation-related irritable bowel syndrome. Manufactured by Sucampo Pharmaceuticals Inc./Takeda Pharmaceuticals USA Inc., it is the first oral drug to relieve constipation caused by opioid therapy for managing noncancer pain.
Constipation is a common side effect for people who take oxycodone, fentanyl or other opioids on a long-term basis. Amitiza was approved by the FDA based on 12-week studies of people on these painkillers.
The drug's effectiveness when taken with diphenylheptane opioids, such as methadone, has not been established, according to the manufacturer. The company also warned that lubiprostone should not be taken by anyone with impaired liver function.