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August 28, 2000
After reports of problems, the FDA is developing a special usage and warning guide for Lotronex, Glaxo Wellcome’s irritable bowel drug.
This decision follows reports that patients on the drug have experienced constipation that has resulted in serious complications, including obstruction, perforation, impaction, toxic megacolon, and secondary ischemia.
Lotronex will be the first prescription drug to have a Medication Guide, which will contain FDA-approved information, written especially for patients so that they will be able to more easily recognize the drug’s risks and take early action to prevent serious harm. Pharmacists will be required to distribute this information with Lotronex.
“Today's actions are an important milestone in enabling consumers, as well as healthcare professionals to better manage the risks that are inherent in even very beneficial drug treatments,” said FDA Commissioner, Dr. Jane E. Henney. “By providing important new safety information about a drug through a Medication Guide to patients, as well as updating the professional labeling, we can better assure that an effective drug can be used safely.”
The new Medication Guide instructs patients to stop taking Lotronex and immediately call their doctor if they become constipated, have new or worsening abdominal pain, or notice blood in their bowel movements.
The updated labeling for physicians will advise that the drug not be prescribed if the patient is currently constipated or has a history of ischemic colitis, intestinal obstruction, Crohn’s Disease, or gastrointestinal perforation.
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