FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Proposes Packaging Reductions to Curb Opioid Addiction

Feb. 6, 2018
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The FDA proposed a new tactic in its fight against the opioid epidemic — blister packs of smaller quantities of opioid drugs that could give providers better prescription options, especially for drugs like Vicodin and Percocet usually intended for short-term use.

“If more immediate release opioid drugs, in particular, were packaged in three or six-day blisterpacks; then more doctors may opt for these shorter durations of use,” said Commissioner Scott Gottlieb, noting that if the agency concluded there was enough scientific support for shorter durations of use, it could justify further regulatory action for appropriate prescribing.

The agency also issued letters to manufacturers of loperamide, an over-the-counter drug used to control short-term diarrhea that has been increasingly abused to induce euphoric effects and to manage opioid withdrawal symptoms.

The letters asked the drugmakers to consider “packaging limitations and unit-of-dose packaging” and to revise the packages to contain a limited amount of loperamide for use in treating short-term diarrhea. One example, Gottlieb stated, is a single retail package containing eight 2-milligram capsules in blister packaging.

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