The FDA ( Food and Drug Administration ) has approved Entereg ( Alvimopan ) to accelerate the restoration of normal bowel function in patients 18 years and up who have undergone partial large or small bowel resection surgery.
Entereg will be used in hospitalized patients who can receive no more than 15 doses.
FDA is approving Entereg with a Risk Evaluation and Mitigation Strategy ( REMS ).The REMS will include limits on dispensing of the drug.
In approving Entereg, FDA determined that a REMS is necessary to ensure that the benefits of Entereg outweigh its risks. The REMS will include restricting Entereg to inpatient use only, requiring that hospitals be specially certified, distribution of educational materials to health care professionals, and regular assessments of the effectiveness of the REMS.
Following major abdominal surgery, some patients develop a condition known as postoperative ileus ( POI ).
POI is a disorder that causes temporary impairment of the gastrointestinal ( GI ) tract's motility, or the ability of the intestines to push out waste products ( not a complete blockage of the GI tract ), following surgery.
POI can be a by-product of a patient taking opioid pain relievers, like morphine, prescribed after surgery which can slow or inhibit normal motility.
Entereg works by blocking opioid effects in the bowel.
The recommended dose for Entereg is one 12 milligram capsule given just prior to surgery and then another 12 mg dose administered twice daily for up to 7 days or not to exceed 15 doses.
The safety and efficacy of Entereg in post-operative patients were demonstrated in five studies that included 2,177 patients, of whom 1,096 received Entereg and 1,081 received placebo.
Bowel recovery times ranged from 10 to 26 hours shorter for Entereg-treated patients compared to placebo-treated patients in the five studies.
The most common side effects reported were low blood calcium levels, anemia and gastrointestinal problems, including constipation, dyspepsia and flatulence.
FDA has reviewed a 12-month study of Entereg in patients treated with opioid medications for chronic pain. In this study, there were more reports of myocardial infarctions in patients treated with a 0.5 mg dose of Entereg twice daily, compared with placebo-treated patients.
This imbalance has not been observed in other studies of Entereg, including studies in patients undergoing bowel resection surgery who took 12 mg of Entereg, twice daily for up to seven days.
A causal relationship with Entereg and myocardial infarction has not been established.
Source: FDA, 2008
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