Over a year ago, I noted that both the DEA and NIDA had expressed concern over the diarrhea treatment loperamide, widely known by the brand name Imodium. Loperamide is an opioid that, with normal use, mostly stays in the gut where it belongs, but which, if it’s taken in massive doses or combined with a P-glycoprotein inhibitor, works its way into the bloodstream and crosses the blood-brain barrier for a pathetic sort of high. Or, if you believe methadone treatment works, the high becomes somewhat less pathetic: loperamide has gotten a reputation among addicts as the poor man’s methadone, a means of easing withdrawal for those done with the dope.
One reason methadone is supposed to work as an addiction treatment is that it’s metabolized so slowly. It has an extremely long half-life (15-55 hours) compared to heroin’s (2-3 minutes). This smooths out the highs and lows to help those treated establish a normal life. Since methadone treatment is dispensed at clinics, not by pushers, it redirects addicts’ dependency toward authorized channels, which regularizes their life in another way. Loperamide has a half-life between heroin’s and methadone’s (9-14 hours). That half-life makes loperamide tempting as “DIY methadone treatment”.
Because both methadone and loperamide are longer-acting drugs, it’s tempting for someone impatient for their effects to kick in (as impatient, maybe, as a heroin addict) to take more and overdose, resulting in an overdose that’s harder to treat. Since methadone isn’t legally available outside of clinics, it’s not possible to overdose on methadone legally. The same can’t be said for loperamide: when used to calm rumbly guts, loperamide is such a safe and useful drug that its supply has so far been unrestricted. But that’s changing. The FDA has just called for more restrictive packaging of loperamide in order to thwart addicts:
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.
Soon, retail packages may only carry a two-day supply of loperamide, each dose encased in a fiddly little blister pack. It’s unclear what will happen to online vendors. Gottleib reasons,
“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.
“On the rise” from only ten deaths in a nearly forty-year period could mean many things. I wonder what counts as an alarming rise.
I also wonder if limiting the availability of “the poor man’s methadone” is such a great idea. First of all, asking loperamide to contain itself makes it harder for law-abiding citizens with gripey guts to contain themselves. But additionally, methadone treatment is expensive and cumbersome; while cheap, accessible loperamide as “DIY methadone”, despite its risks, allows for affordable self-treatment.
Admittedly, methadone treatment is cumbersome by design. When addicts use loperamide as a methadone substitute, part of the problem is that they’re doing it themselves: druggies aren’t exactly the type you would trust with self-treatment. Nonetheless, having self-treatment available is often better than not having it available.
Our state limits sales of pseudoephedrine (Sudafed) to two packages a day. You show the pharmacist your ID and sign a registry. It’s annoying, but often not very cumbersome. (I hear that changes when a parent has to buy for a whole family with sinus problems.) Even so, many of us wonder, why should law-abiding people be encumbered at all? Is it right? Is it worth it?
Where loperamide is concerned, these questions may be even more urgent. After all, how long do you wanna hafta stand in line for the pharmacist for your measly two-day supply while the thunder rolls?