FDA OKs New Bowel Drug Entereg
Drug May Only Be Used in Hospitalized Adults Who've Had Part of Their Large or Small Bowel Removed
May 30, 2008 -- The FDA has approved a new drug called Entereg to speed the recovery of normal bowel function in hospitalized adults who've had part of their large or small bowel surgically removed.
Entereg will only be given in hospitals that are specially certified, as part of an FDA system to make sure the drug's benefits outweigh its risks.
The FDA approved Entereg based on five studies that together included 2,177 patients who had had part of their large or small bowel removed. The patients took either Entereg or a placebo.
Bowel recovery time happened 10-26 hours faster in the patients taking Entereg. The most common side effects included low blood calcium levels, anemia, and gastrointestinal problems including constipation, heartburn, and flatulence, according to the FDA.
The FDA has reviewed a yearlong study of Entereg in patients treated with opioid medications for chronic pain. In that study, there were more reports of heart attacks in patients treated with a 0.5 milligram dose of Entereg twice daily, compared with patients taking a placebo. That finding didn't appear in other Entereg studies, and it's not clear that Entereg caused any heart attacks, the FDA notes in a news release.
Entereg, which isn't approved for use in children and teens younger than 18, is made by Adolor Corp. of Exton, Pa. Adolor and the drug company GlaxoSmithKline are collaborating on Entereg's development and marketing.