Other safety alerts
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| The United States: FDA Drug Safety Communication: FDA warns about serious heart problems with high doses of the antidiarrheal medicine loperamide (Imodium), including from abuse and misuse |
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The U.S. Food and Drug Administration (FDA) is warning that taking higher than recommended doses of the common over-the-counter (OTC) and prescription diarrhea medicine loperamide (Imodium), including through abuse or misuse of the product, can cause serious heart problems that can lead to death. The risk of these serious heart problems, including abnormal heart rhythms, may also be increased when high doses of loperamide are taken with several kinds of medicines that interact with loperamide. A list of examples of drugs that can potentially interact with loperamide is included at the FDA website.
In the 39 years from when loperamide was first approved in the U.S. in 1976 through 2015, FDA received reports of 48 cases of serious heart problems associated with use of loperamide. This number includes only reports submitted to FDA, so there are likely additional cases about which FDA is unaware. Thirty-one of these cases resulted in hospitalizations, and 10 patients died. More than half of the 48 cases were reported after 2010. The serious heart problems occurred mostly in patients who were taking doses that were much higher than recommended. In other cases, patients were taking the recommended dose of loperamide, but they were also taking interacting medicines, causing an increase in loperamide levels. Additional cases of serious heart problems associated with the use of loperamide were reported in the medical literature. Cases reported to FDA and in the medical literature indicate that individuals are taking significantly high doses of loperamide in situations of both misuse and abuse, often attempting to achieve euphoria or self-treat opioid withdrawal. They are also combining loperamide with interacting drugs in attempts to increase these effects. The FDA continues to evaluate this safety issue and will determine if additional FDA actions are needed.
Healthcare professionals should be aware that use of higher than recommended doses of loperamide can result in serious cardiac adverse events. Consider loperamide as a possible cause of unexplained cardiac events including QT interval prolongation, Torsades de Pointes or other ventricular arrhythmias, syncope, and cardiac arrest. In cases of abuse, individuals often use other drugs together with loperamide in attempts to increase its absorption and penetration across the blood-brain barrier, inhibit loperamide metabolism, and enhance its euphoric effects. If loperamide toxicity is suspected, promptly discontinue the drug and start necessary therapy. If loperamide ingestion is suspected, measure blood levels, which may require specific testing. For some cases of Torsades de Pointes in which drug treatment is ineffective, electrical pacing or cardioversion may be required.
FDA reminded healthcare professionals to advise patients taking loperamide to follow the dosing recommendations on the label because taking higher than recommended doses, either intentionally or unintentionally, may lead to abnormal heart rhythms and serious cardiac events leading to death. Also advise patients that drug interactions with commonly used medicines also increase the risk of serious cardiac adverse events. Healthcare professionals should refer patients with opioid use disorders for treatment.
Patients and consumers who have diarrhea lasting more than 2 days should stop taking loperamide and contact their health care professional. Seek medical attention immediately if they experiences any of the following: fainting, rapid heartbeat or irregular heart rhythm, or unresponsiveness.
Please refer to the following website in FDA for details:
http://www.fda.gov/Drugs/DrugSafety/ucm504617.htm
In Hong Kong, there are 68 registered pharmaceutical products containing loperamide. So far, the Department of Health (DH) has not received any adverse drug reaction case related to loperamide. In view of the above FDA announcement, letters to local healthcare professionals to draw their attention to the warning will be issued. As FDA is evaluating this safety issue to determine if additional actions are needed, DH will remain vigilant on the conclusion of the evaluation and any safety updates by other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/ Wednesday, June 08, 2016
Issued at HKT 16:00
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