FDA is requiring limits on the amount of pills per package and requiring unit-dose blister packaging on certain over-the-counter anti-diarrhea medications due to abuse.
In a new Safety Announcement, FDA said it is requiring changes to certain packages of loperamide drugs: Imodium A-D (McNeil Pharmaceuticals), Imodium Multi-Symptom Relief and Be Health Loperamide HCl Capsules.
“Abuse of loperamide continues in the US, and taking higher than recommended doses can cause serious heart problems that can lead to death,” said Acting FDA Commissioner Ned Sharpless, MD, in a FDA announcement.
The agency worked with manufacturers to approve package size limitations and unit-dose packaging for certain over-the-counter loperamide products, Sharpless added.
“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,” Sharpless said.
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The maximum approved daily dose of OTC loperamide for adults is 8 mg per day and 16 mg 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.
As a result, 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. 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 agency said.