Health care 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.
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. Refer patients with opioid use disorders for treatment see Additional Information for Health Care Professionals.
Patients and consumers should only take loperamide in the dose directed by their health care professionals or according to the OTC Drug Facts label. Do not use more than the dose prescribed or listed on the label, as doing so can cause severe heart rhythm problems or death.
If your diarrhea lasts more than 2 days, stop taking loperamide and contact your health care professional. Seek medical attention immediately by calling if you or someone taking loperamide experiences any of the following:.
Ask a pharmacist or your health care professional if you are not sure how much loperamide to take, how often to take it, or whether a medicine you are taking may interact with loperamide. Always tell your health care professionals about all the medicines you are taking, including OTC medicines see Examples of Drugs that Can Potentially Interact with Loperamide. The maximum approved daily dose for adults is 8 mg per day for OTC use and 16 mg per day for prescription use.
This number includes only reports submitted to FDA, so there are likely additional cases about which we are unaware. Thirty-one of these cases resulted in hospitalizations, and 10 patients died. More than half of the 48 cases were reported after 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. They are also combining loperamide with interacting drugs in attempts to increase these effects. If you are not sure if a medicine you are taking interacts with loperamide, ask a pharmacist or your health care professional. Some cases reported more than one cardiac event. Ten cases resulted in death.
Nine of the deaths were due to ingestion of large amounts of loperamide, and there was one sudden cardiac death after the patient ingested an unknown amount of loperamide.
In many cases, standard antiarrhythmic medications were ineffective and only electrical pacing resulted in control of the arrhythmias. Twenty-two of the 48 cases reported that the patients were abusing high doses of loperamide, and 17 cases reported that the patients were taking loperamide to treat diarrhea. Among the 17 patients who used loperamide for diarrhea, 11 reported taking therapeutic doses of loperamide, 5 reported using higher than recommended doses, and one did not report a loperamide dose.
Of the cases that reported a loperamide dose, the mean dose was mg per day range 1 to mg per day. If any of these occur, should be contacted immediately to get medical attention. Forty-eight cases of serious heart problems associated with Imodium have been reported to the FDA between , when it was approved, and last year.
More than half of them occurred after This includes 10 reported deaths. However, the agency believes the actual number of cases is higher because not all incidents are reported to the FDA. Last Name. Have Your Comments Reviewed by a Lawyer Provide additional contact information if you want an attorney to review your comments and contact you about a potential case.
This information will not be published. Contact Phone. Alt Phone. Private Comments. Eastern Time. A link to the recall notice is here.
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