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The US Food and Drug Administration said on Tuesday that it will work with pharmaceutical companies to prevent the abuse of Imodium, a popular antidiarrheal drug, as an opioid. Sold generically as loperamide, the drug will soon be sold in blister packs and single-dose packs to cut the chance of overdose.
Dr. Scott Gottlieb, the FDA commissioner, said that loperamide is sometimes taken in large doses by people who seek to suppress the symptoms of withdrawal from other opioids such as heroin. He warned that overdose of loperamide can lead to cardiac problems and even death, CNN reported.
New ways to reduce exposure to opioids
He said that with more than 40 people dying every day from overdoses that involved prescription opioids, more vigilant action is needed from the FDA to get ahead of the crisis. Gottlieb added that 11.5 million Americans misused prescription opioids in 2017.
One of FDA’s key roles in addressing the opioid epidemic is to reduce new addiction. Using the agency’s Risk Evaluation and Mitigation Strategy authorities, the FDA can explore ways to reduce exposure to opioids, he said.
He said that if more immediate-release opioid drugs, such as Percocet and Vicodin, are packaged in three- or six-day blister packs, more doctors may select the shorter duration of use. The commissioner said there is sufficient scientific support for the shorter duration of use.
The FDA requested the manufacturer of loperamide to also change the way they label and package the drugs to stem abuse and misuse. Under FDA guidelines, the maximum approved daily dose for adults is 8 milligrams daily of over-the-counter use. For prescription use, it is 16 milligrams per day.
Safe at approved doses
Gottlieb said that at those approved doses, loperamide is safe. However, when people overdose, it could result in serious cardiovascular problems and deaths, particularly among people who intentionally misuse or abuse high doses of loperamide.
In the spring of 2017, the agency added a warning to the product label to warn of ingesting high doses of the antidiarrheal drug. The FDA said it sent letters on Tuesday to over-the-counter manufacturers of loperamide to implement changes made up of packaging limitations and unit-of-dose packaging.
The package must contain a limited amount of loperamide enough for use for short-term diarrhea, according to the product label. It cited as an example a single retail package that should contain eight 2-milligram capsules in blister packaging.
Gottlieb said that the FDA will also reach out to online distributors of loperamide to ask them to take voluntary steps to help the agency address the issue of abuse. To abuse the drug, it requires the purchase of extremely large quantities of loperamide which is done by purchasing a large bottle of the medication, a common configuration of how the pill form of loperamide is currently packaged. Some generic versions of the drug are sold in boxes of up to 200 tablets, Associated Press reported.
The commissioner said that anyone distributing healthcare products has an obligation to be a partner in helping curb pressing public health challenges like the opioid abuse. He reminded the sellers that they have a social contract to take voluntary steps to help address the public health challenges.
In October, US President Donald Trump called the opioid epidemic a national public health emergency.
In 2017, a report in the Annals of Emergency Medicine medical journal described two patients who died after they took large doses of loperamide to curb their opioid withdrawal. The deaths were not the result of the opioid itself but from the other ingredients in loperamide that are toxic to the heart.
Addictive drug classes, such as morphine and oxycodone, are among the key ingredients in antidiarrheal medications such as Imodium which is part of the opioid family.
In a 2017 study, 15 deaths were linked to loperamide between 2010 and 2016, according to researchers.
Loperamide misuse is quite common among teenagers, Dr. Robert Gatter, an assistant professor of emergency medicine at Northwell Health in New York, said. He added that a lot of teens, who use different nicknames for loperamide, are aware of its misuse and abuse.
In 1976, Imodium was first approved as a prescription medication. In 1988, it became available without a prescription, one of the few over-the-counter drugs for diarrhea.
In September, the Consumer Healthcare Products Association, a top trade group, told the FDA that over-the-counter sale of Johnson & Johnson’s Imodium A-D should not be stopped despite the increase in fatal overdoses, Law360 reported. The letter was in response to a citizen petition submitted in December by the US Department of Veteran Affair physician after the FDA issued a safety alert about the abuse of loperamide.
The FDA also welcomes and encourages the public to submit written or electronic comments to its docket until March 16, 2018, Gottlieb said.
[메디컬리포트=Vittorio Hernandez 기자]