September 20, 2019
“Abuse of loperamide continues in the United States, and taking higher than recommended doses can cause serious heart problems that can lead to death,” said Acting FDA Commissioner Ned Sharpless, M.D. “The FDA has worked with manufacturers to approve package size limitations and unit-dose packaging for certain over-the-counter loperamide products. 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. We are requesting that online distributors take voluntary steps to help reduce the risks of loperamide abuse and misuse by not selling more than one package of these drugs to each customer. We are also taking steps to make sure that consumers can easily access and read the product labeling and warnings for drugs sold on shelves or on websites before purchase.”
Today, the U.S. Food and Drug Administration announced approved package size and package type limits for over-the-counter (OTC) brand-name tablet and capsule forms of loperamide, an FDA-approved drug product that helps control symptoms of diarrhea, including Travelers’ diarrhea. The changes to Imodium A-D, Imodium Multi-Symptom Relief and Be Health Loperamide HCl Capsules are intended to address the problem of loperamide abuse and misuse by limiting each carton to no more than 48 mg of loperamide and requiring unit-dose blister packaging.
The maximum approved daily dose of OTC loperamide for adults is 8 milligrams per day and 16 milligrams per day for prescription use. While loperamide is safe at approved doses, the FDA has received reports of serious heart problems and deaths associated with loperamide, and the majority of reported serious heart problems occurred in individuals who were intentionally misusing and abusing high doses of loperamide. A Heart Alert warning was added to loperamide Drug Facts labels in the spring of 2017 to warn consumers that taking more than directed can cause serious heart problems or death. Evidence suggests that package size limitations and use of unit-dose packaging may reduce medication overdose and death.
In 2018, the FDA requested that manufacturers and packagers of OTC loperamide products change the way they label and package loperamide to support safe use. The FDA continues to review this important safety issue and to work with manufacturers, including manufacturers of generic and liquid loperamide products, to make appropriate packaging changes to support the safe use of those products.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.