(RxWiki News) In order to help ensure patient safety, the US Food and Drug Administration (FDA) has approved new packaging for a common anti-diarrhea medication.
These changes to the packaging of loperamide products were meant to promote safe use of these medications. Loperamide can be found under the brand name products Imodium A-D and Imodium Multi-Symptom Relief.
These over-the-counter (OTC) medications are approved to control symptoms of diarrhea, including travelers’ diarrhea.
“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 Dr. Ned Sharpless in a press release.
These newly approved changes require the package to be unit-dosed and limit each package to no more than 48 mg of loperamide.
Loperamide is safe at approved doses. The maximum loperamide dose per day is 8 mg (OTC) and 16 mg (prescription).
When taken at much higher than recommended doses, though, there is a safety issue.
Back in 2018, the FDA asked OTC loperamide manufacturers to make changes to the label and package to ensure safe use.
This was a result of continued reports of serious heart problems tied to higher-than-recommended doses of loperamide. These reports were primarily among those who intentionally misused or abused loperamide.
In 2017, a warning stating that taking more than directed can cause serious heart problems or death was added to the label.
Speak with your health care provider if you have any questions.
Written by Anyssa Garza, PharmD, BCMAS