U.S. Food and Drug Administration Commissioner Scott Gottlieb said the addiction epidemic in the U.S. is migrating to substances his agency would not have suspected five or 10 years ago to be agents people would use to get high, such as the anti-diarrhea drug Imodium and the botanical substance kratom.
Gottlieb on Feb. 6 declared kratom to be an opioid and said the product was helping to fuel the U.S. addiction epidemic.
The agency warned in November 2017 that kratom, a plant that grows naturally in places including Thailand, Malaysia, Indonesia and Papua New Guinea, was implicated in 36 deaths and urged Americans to stop using the substance, which some people have been taking to treat opioid addiction or to control pain, anxiety or depression.
But Gottlieb said there is no evidence kratom is effective in treating those conditions, and the FDA's analysis demonstrated that the product is harmful.
"As the scientific data and adverse event reports have clearly revealed, compounds in kratom make it so it isn't just a plant — it's an opioid," Gottlieb wrote in a lengthy statement.
For those who argue kratom is safe because it's "just a plant," Gottlieb reminded Americans that heroin is also derived from poppy plants.
Claiming kratom is benign is "shortsighted and dangerous," he said.
At a Feb. 6 event hosted by the advocacy group the Alliance for a Stronger FDA, Gottlieb said the agency's analysis is being used by the Drug Enforcement Administration to consider whether to declare kratom a controlled substance.
An unexpected migration
While the FDA has been concerned about the increasing use of "street drugs," like heroin laced with fentanyl, which Gottlieb attributed to the soaring number of addiction-related deaths, the epidemic that started with prescription opioids is migrating to products like kratom and Imodium, he said.
"We are starting to see some of the addiction behavior migrate into these places where we never would have imagined five years ago," Gottlieb said.
The FDA on Jan. 30 warned about the misuse and abuse of Imodium, also known as loperamide, to get high, alerting Americans that taking high doses could result in serious heart problems or death.
He noted during the Feb. 6 event that people were buying up bottles of 100-count and 200-count Imodium and grinding the pills up and putting them into milkshakes to get high.
The FDA is now working with manufacturers to limit the number of pills by putting the product into unit-dose packaging, such as "blister packs" of eight tablets, Gottlieb said.
"I'm also going to be making calls to supply chain intermediaries supplying bulk substance and online sites and retailers to try to encourage them to exercise some public health judgment in what they make available and how they are selling this," he said.
"Who thought we'd be talking about loperamide five or 10 years ago with respect to an addiction problem," Gottlieb told reporters. "So it's going to require us to think differently about what we do, and look for new and creative ways to try to get ahead of this."
Immediate-release opioid blister packs
Gottlieb said the FDA was considering possibly limiting immediate-release opioids, such as Vicodin, Percocet or OxyContin, by also packaging them in blister packs to reduce the exposure of the products.
He said the FDA has been talking with lawmakers on Capitol Hill and holding internal discussions about how to go about using blister packaging for immediate-release opioids.
"We think that if the [immediate-release] formulations of the drugs were more commonly available in packs that comported with clinical guidelines for what appropriate dispensing should be — whether it's three days, seven days or 14 days, probably not 30 days — then more doctors would more reflectively write for those packs and you would have lower overall exposure," Gottlieb said.
But there were some questions over whether the FDA already has the authority to require such packaging or will need Congress to act, he added.
The agency is also considering whether setting up a voluntary process with manufacturers and suppliers would be more effective instead of mandating they use blister packages, Gottlieb said.
He said the FDA is expected to reveal more details about immediate-release blister packaging in the coming days.
Reducing exposure
Gottlieb noted that about 50% of Americans who have become addicted to opioids were first exposed to the drugs through a lawfully written prescription, and in up to 90% of the cases, it was an immediate-release formulation of the products.
Earlier this year, Gottlieb listed the opioid crisis — an epidemic that is taking the lives of nearly 100 Americans every day — among his top priorities for 2018, insisting that reducing inappropriate prescribing of opioids was critical to success.
"If you can reduce exposure, you can reduce new addiction. It's math, to some degree," Gottlieb declared at the Feb. 6 event.
President Donald Trump, however, has decided his administration should be focused first on putting money into building a wall on the border between the U.S. and Mexico as the solution to the epidemic, declaring it would help keep illicit opioids out of the reach of Americans.
