FDA Intervenes With Anti-Diarrhea Drug Packaging

Saturday, 03 Feb, 2018

Comilla Sasson says what the memo really concerns is Loperamide, which is the active ingredient in Imodium and something that can help people experiencing opioid withdrawal symptoms.

Some manufacturers of loperamide, an anti-diarrhea medicine known by the brand name Imodium, are already selling their pills in blister packs to thwart tampering and make it more hard for opioid addicts to abuse it.

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. The drug is cheap, costing about $10 for 400 capsules.

The recommended dose of loperamide is 8 milligrams a day for over-the-counter use and 16 milligrams a day for prescription use. It can also relieve withdrawals from drugs like heroin. The majority of reported cases where heart problems developed were due to intentional abuse. To prevent this, the FDA is working with manufacturers to implement the use of blister packs and other single dose packaging to minimize the number of doses in each package.

In a statement, FDA Commissioner Scott Gottlieb M.D. called for immediate action on the part of manufacturers.

The issue has become so widespread that the FDA is asking manufacturers to change packaging in an effort to cut down on abuse. It also is suggesting that companies limit the number of doses per package. After that, if pain persists, they will be prescribed refills in a limited 30-day supply.