FDA warns of heart attack risk with bowel surgery drug Entereg

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by Jim Orr

The Food and Drug Administration has issued a black box warning concerning a link between the bowel surgery drug Entereg (alvimopan) and an increased risk of heart attack. Based on these findings, the agency has warned that the drug should only be prescribed for a short period of time to patients who are being treated in a hospital.

Entereg is a prescription medication that it prescribed to patients who are recovering from bowel surgery. The drug is designed to help restore normal bowel function and speed up the recovery period for patients who have undergone surgery on the bowel or GI tract. The drug works by blocking the effects of hormones and opioid drugs on the bowels, which helps to prevent a condition known as post-operative ileus from developing.

According to the FDA’s warning, patients who underwent long-term treatment with Entereg during clinical trials for the drug were more likely to experience a myocardial infarction, or heart attack. The majority of heart attacks among Entereg users occurred within one to four months of beginning treatment.

As a result of these findings, the agency has advised doctors to prescribe the drug for a period of no longer than 15 doses—or about two weeks—in order to limit the risk of heart attack in patients. Under a program called Entereg Access Support and Education (E.A.S.E.), the drug should also only be prescribed to patients in a hospital setting due to the heart attach risks of the drug.

The FDA also warned that certain groups of patients may be more susceptible to heart attack or other complications of taking Entereg, including:

  • Patients who were recently treated with opioid painkillers
  • Patients with suffering from severe hepatic impairment or other liver problems
  • Patients with a complete gastrointestinal obstruction
  • Patients with pancreatic or gastric anastomosis

The FDA recommended that Entereg should not be prescribed to any of these patient groups due to the increased risk of complications from the drug.

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