FDA limits packaging of anti-diarrhoea medicine amid patient safety concerns

The US Food and Drug Administration (FDA) has issued a safety communication concerning the limitation of packaging for anti-diarrhoea medicine, loperamide, as a result of product misuse and abuse.

Loperamide is an opioid-receptor agonist that has been FDA-approved for the relief of symptoms of diarrhoea and is safe to use when taken as directed. However, there have been reports of serious heart problems and deaths received by the agency as a result of people taking vast amounts of the drug.

This packaging limitation will involve the use of blister packs or other single dose packaging forms to limit the number of doses per pack. The maximum approved daily dose of loperamide for adults is 8 mg per day for over-the-counter (OTC) use and 16 mg per day for prescription use.

The FDA is working with manufacturers to encourage the safe use of this medication as a part of its continued efforts in tackling the opioid crisis. It is urging patients, consumers and healthcare professionals to report side effects involving loperamide or other medicines to the FDA MedWatch programme.