Federal regulators hope new size limits and packaging changes will help prevent abuse and misuse of Imodium A-D, reducing the risk of overdose injuries linked to the anti-diarrhea medication.
The U.S. Food and Drug Administration (FDA) issued a drug safety communication on September 20, approving new limits on how many pills can be sold per package of loperamide, which is sold under the brand name Imodium, as well as other generic labels.
According to the FDA, the package limits are aimed at curbing Imdium misuse, and improving the safety of the over-the-counter medication, without limiting access to consumers who use the products in an approved and safe manner.
The limits call for each carton to have no more than 48 mg and require unit-dose blister packaging. The maximum approved dose for adults is 8 mg per day and 16 mg per day for prescription use.
Imodium is approved to control symptoms of diarrhea, including traveler’s diarrhea, by acting on the opioid receptors in the intestines to slow the number of bowel movements. However, some individuals use it with other drugs to increase the absorption across the blood-brain barrier, causing euphoric effects. In other cases, people abuse the medication by taking high doses to treat opioid withdrawal.
The FDA has received numerous reports of serious heart problems from Imodium misuse, involving individuals who intentionally took high doses of the medication.
“Abuse of loperamide continues in the United States, and taking higher than recommended doses can cause serious heart problems that can lead to death,” Acting FDA Commissioner Ned Sharpless said in a press release. “These changes are intended to increase the safe use of loperamide products without limiting over-the-counter access for consumers who use these products for their approved uses at the approved dose, according to labeling.”
The FDA added a Heart Alert warning to the Drug Facts labels on loperamide products in 2017. The label warned consumers taking more of the medication than directed that it can cause serious heart problems or even death.
Other side effects of Imodium abuse can include abnormal heart rhythms, serious cardiac events, QT interval prolongation, a disruption of the heart’s electrical cycle, or an abnormal hearth rhythm that can cause sudden cardiac death, syncope, cardiac arrest, or other ventricular arrhythmias.
The agency claims that evidence indicates package size limits and unit-dose packaging may help reduce medication misuse, overdose, and death.
The FDA first began working with manufacturers on limiting the amount per package in 2018.
In addition to the package size limits, the agency requested online distributors take voluntary steps to help reduce the risks of abuse and misuse by not selling more than one package of the drugs to each customer.