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(Last Updated On: June 15, 2018)

Imodium (loperamide) for Over-the-Counter Use: FDA Limits Packaging to Encourage Safe Use

The National Agency for Food and Drug Administration and Control has been informed by the United States Food and Drug Administration that it is working with manufacturers of Imodium (loperamide) to use blister packs or other single dose packaging and to limit the number of doses in a package. This is to foster the safe use of the over-the counter (OTC) anti-diarrhea drug loperamide. This is as a result of increased reports of serious heart problems and deaths with much higher than the recommended doses of loperamide, primarily among people who are intentionally misusing or abusing the product, despite the addition of a warning to the medicine label.

Loperamide is FDA-approved to help control symptoms of diarrhea. It acts on opioid receptors in the gut to slow the movement in the intestines and decrease the number of bowel movements. Loperamide is a safe drug when used as directed.

Possible Risks

Intake of much higher dose than recommended can lead to serious problems, including severe heart rhythm problems and death.

Consumer/ Healthcare Provider Action

  • Patients and consumers should only take the dose of loperamide directed by your health care professionals or according to the OTC Drug Facts label.
  • Health care professionals should be aware that using much higher than recommended doses of loperamide, either intentionally or unintentionally, can result in serious cardiac adverse events.
  • Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to NAFDAC PRASCOR (20543- Toll free from all networks) or via pharmacovigilance@nafdac.gov.ng

NAFDAC…………Safeguarding the health of the Nation

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