Diarrhea Drug Involved in Growing Number of Overdoses

By Pat Anson, PNN Editor

A little over a year ago, the Food and Drug Administration asked Johnson & Johnson and other drug makers to limit the number of anti-diarrhea pills they sell. FDA commissioner Scott Gottlieb, MD, said the “unprecedented and novel action” was needed because Imodium and other over-the-counter formulations of loperamide were being abused by opioid addicts.  

A few of us guffawed at the news as another example of government regulation gone amuck.

But it turns out there is cause for concern.

Researchers at Rutgers University have documented that overdoses of loperamide have been steadily increasing in number and severity, and have even resulted in some deaths.

Their study, published in the journal Clinical Toxicology, found a growing number of people addicted to opioids who are using loperamide to prevent or self-treat withdrawal symptoms. Some are even taking massive doses to get a high similar to heroin, fentanyl or oxycodone.

The New Jersey Poison Control Center has reported several fatalities or near-fatalities from loperamide in the past 12 months.

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“When used appropriately, loperamide is a safe and effective treatment for diarrhea – but when misused in large doses, it is more toxic to the heart than other opioids which are classified under federal policy as controlled dangerous substances,” said senior author Diane Calello, MD, executive director of New Jersey Poison Control at Rutgers New Jersey Medical School.

“Overdose deaths occur not because patients stop breathing, as with other opioids, but due to irregular heartbeat and cardiac arrest.”

The researchers reviewed toxicology cases in a national poison control center database from 2011 to 2016, and found a 91 percent increase in loperamide overdoses during that time period.  In 2015 alone, there were 916 cases and two deaths.

Patients who misused loperamide were predominantly young Caucasian men and women. The majority used extremely high doses of loperamide, the equivalent of 50 to 100 two-milligram pills per day.

“Possible ways of restricting loperamide misuse include limiting the daily or monthly amount an individual could purchase, requiring retailers to keep personal information about customers, requiring photo identification for purchase and placing medication behind the counter,” Calello said. "Most importantly, consumers need to understand the very real danger of taking this medication in excessive doses."

Misuse of loperamide is concerning because it is readily available over-the-counter, undetectable in routine drug tests, and can be bought in large quantities online or in retail stores.

In 2017, the FDA added a warning label to loperamide products cautioning consumers not to ingest high doses. Some drug makers are now selling the anti-diarrhea pills in smaller packages and in blister packs that are harder to open.

Montezuma's Revenge: FDA to Limit Diarrhea Pills

By Pat Anson, Editor

Federal efforts to combat the opioid crisis entered a surprising new phase today, with the Food and Drug Administration asking Johnson & Johnson and other drug makers to limit the number of anti-diarrhea pills they sell.

You read that right.

FDA commissioner Scott Gottlieb, MD, said the “unprecedented and novel action” was needed because Imodium and other over-the-counter formulations of loperamide are being abused by opioid addicts.  

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The FDA wants J&J and other drug makers to limit the number of pills in loperamide packaging so that there are just enough to treat short-term diarrhea, such as traveler’s diarrhea. – also known as Montezuma’s Revenge.

“Abuse of loperamide has been increasing in the United States. When used at extremely high and dangerous doses, it’s seen by those suffering from opioid addiction as a potential alternative to manage opioid withdrawal symptoms or to achieve euphoric effects of opioid use,” Gottlieb said in a statement.

“When higher than recommended doses are taken we’ve received reports of serious heart problems and deaths with loperamide, particularly among people who are intentionally misusing or abusing high doses.”

Last year the FDA added a warning label to loperamide products cautioning consumers not to ingest high doses. The agency believes further safety measures are needed to make it harder for people to buy loperamide in large quantities. The FDA is suggesting that loperamide be sold in packages containing a two day supply of eight 2-milligram capsules. Imodium packages currently contain as many as 42 capsules.

“The abuse of loperamide requires the purchase of extremely large quantities. Often this is done through the purchase of large bottles of loperamide, which is a common configuration in which the pill form of the medication is currently packaged,” said Gottlieb. “Today’s action is intended to change how the product is packaged, to eliminate these large volume containers. We know that many of the bulk purchases of these large volumes are being made online through major online web retailers.”

The FDA is also considering changes in how opioid medication for acute short-term pain is packaged. Several states have enacted laws that require first time prescriptions for acute pain be limited to 5 or 7 days’ supply

“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. 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.

Some users of Imodium are unhappy the medication now comes in blister packs – saying the packages are too hard and frustrating to open at an urgent time of need.

“There's nothing worse than having diarrhea and you can't get the package open,” one woman wrote on the Imodium website. “The only way I can get it open is to find a pair of scissors and cut it open. I tried one time to tear it open with my teeth and ended up cutting my lip.”

“Your product inside the box is quite good. I just wonder who convinced Imodium powers that be to change the blister units in which the caplets are packaged. I have almost lost my religion trying to tear open at the suggested/new perforation. It is horrible!” another woman wrote.

“Had to make 3 trips to the bathroom while trying to get the caplet wrapper open, packaging needs changing,” said another reviewer.