- The Food and Drug Administration is asking manufacturers of the over-the-counter antidiarrheal loperamide to change how the drug is packaged to help limit abuse by individuals addicted to opioid painkillers, a new step in its efforts to stem the public health crisis.
- Loperamide, originally marketed as Imodium but now generic, is used by some at high doses to stave off withdrawal symptoms or to get a similar "high" to opioid use. Higher-than-intended doses, however, can cause heart problems and death, the FDA warns.
- The regulator is also exploring how changes in packaging could help reduce the abuse potential of immediate-release formulations of opioids like Percocet and Vicodin.
The U.S. continues to grapple with the opioid crisis, pushing the FDA to widen its approach in combating abuse. To date, the regulator has focused on dosing and prescription length, improving access to addiction treatment, and supporting less addictive pain therapeutics.
On the legal front, individual cities and states across the country have filed lawsuits against manufacturers. And some cities are resorting to more unorthodox approaches, including sewage-sniffing robots to track opioid use.
The FDA's next step is to examine how the packaging of opioids and other drugs link to abuse. Loperamide, widely sold as in different generic versions, is used at high doses to self-manage opioid withdrawal symptoms by users, and to induce euphoria.
Dubbed "poor man's methadone," large doses of loperamide have been linked with heart problems and deaths, spurring the FDA to add a warning to the label last year. The agency now urges the use of smaller packs that will make it harder for users to obtain large enough quantities. To this end, the FDA will also contact loperamide online retailers to ask them to take voluntary steps to limit the sales of bulk quantities of loperamide tablets.
The packaging approach could also help tailor prescribing, making is easier to prescribe short courses of other opioid drugs.
"If more immediate release opioid drugs, in particular, were packaged in three or six-day blister packs; then more doctors may opt for these shorter durations of use," said FDA Commissioner Scott Gottlieb.
The move follows another recent step aimed at stopping companies from illegally marketing unapproved products with claims to help with opioid addiction and withdrawal. The FDA, together with the Federal Trade Commission, posted joint warning letters to the marketers and distributors of 12 opioid cessation products.
"People who are addicted to opioids should have access to safe and effective treatments and not be victimized by unscrupulous vendors who are trying to capitalize on the opioid epidemic by taking advantage of consumers and selling products with baseless claims," said FDA Commissioner Scott Gottlieb in a Jan. 24 statement.
The FDA has also posted a revised and updated blueprint for healthcare providers to support the treatment and monitoring of people with pain.