Boxes of Johnson & Johnson's popular antidiarrheal drug Imodium could soon contain far fewer caplets under a Food and Drug Administration request that seeks to limit access of drug abusers to pills that can produce an opioid-like high.
The FDA has asked J&J to reduce the number of caplets in over-the-counter retail packages of Imodium to provide for short-term diarrhea treatment, a move would be followed by makers of generic versions of Imodium.
FDA Commissioner Scott Gottlieb called the agency request "fairly unprecedented" in a statement on Tuesday and said those restrictions could constitute a two-day supply, or a maximum of eight two-milligram pills. J&J was noncommittal.
The steps to limit Imodium are part of a broader FDA effort to stem the tide of overdose deaths. More than 42,000 Americans died from opioid overdoses in 2016, according to the Centers for Disease Control and Prevention.
The FDA is also considering whether it can use packaging to stem access to certain fast-acting opioids such as Vicodin and Percocet that are meant for short-term use, Gottlieb said. For example, doctors may opt to prescribe fewer pills if such opioids were packaged in three- or six-day blister packs, he said.
"Additionally, provided the FDA concluded that there was sufficient scientific support for these shorter durations of use, this could provide the basis for further regulatory action to drive more appropriate prescribing," Gottlieb said.
The FDA warned in 2016 that people were using high doses of the active ingredient in Imodium, loperamide, to self-treat opioid withdrawal symptoms or to achieve a feeling of euphoria. Taking the drug in large quantities could lead to serious heart problems that could be fatal, according to the agency.
"We're evaluating the agency's request and share their goal to prevent misuse and abuse," Carol Goodrich, a spokeswoman for J&J, said in an e-mail.
On its website, J&J links to sellers who offered Imodium in packages of 24 to 48 caplets. Other stores, including Amazon.com and Walmart, had generic versions available online in bottles of as much as 200 pills. Gottlieb said packaging restrictions should make it easier to limit sales, and he plans to ask online retailers to address loperamide abuse.
"If you're selling a drug with the potential for abuse and misuse through an online website, you're no longer in the business of selling widgets, or books," Gottlieb said. "You have a social contract to take voluntary steps to help address public health challenges."
Ten deaths from loperamide use were reported to FDA from its approval in 1976 through Dec. 14, 2015. The agency hasn't updated those numbers, but it says abuse of the drug is on the rise.
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