(loe per' a mide)
Pepto® Diarrhea Control
Imodium® Multi-Symptom Relief (as a combination product containing Loperamide, Simethicone)
AUDIENCE: Consumer, Pharmacy, Family Practice
ISSUE: To foster safe use of the over-the counter (OTC) anti-diarrhea drug loperamide, FDA is working with manufacturers to use blister packs or other single dose packaging and to limit the number of doses in a package. FDA continues to receive reports of serious heart problems and deaths with much higher than the recommended doses of loperamide, primarily among people who are intentionally misusing or abusing the product, despite the addition of a warning to the medicine label and a previous communication. Loperamide is a safe drug when used as directed.
Loperamide acts on opioid receptors in the gut to slow the movement in the intestines and decrease the number of bowel movements. It is safe at approved doses, but when much higher than recommended doses are taken, it can lead to serious problems, including severe heart rhythm problems and death.
FDA is continuing to evaluate this safety issue and will update the public when more information is available.
BACKGROUND: Loperamide is FDA-approved to help control symptoms of diarrhea, including Travelers' Diarrhea. The maximum approved daily dose for adults is 8 mg per day for OTC use and 16 mg per day for prescription use. It is sold under the OTC brand name Imodium A-D, as store brands, and as generics.
FDA previously issued a Drug Safety Communication about this safety concern in 2016, and added warnings about serious heart problems to the drug label of prescription loperamide and to the Drug Facts label of OTC loperamide products.
RECOMMENDATION: Patients and consumers should only take the dose of loperamide directed by your health care professionals or according to the OTC Drug Facts label, as taking more than prescribed or listed on the label can cause severe heart rhythm problems or death. If you are using OTC loperamide and your diarrhea lasts more than 2 days, stop taking the medicine and contact your health care professional.
Seek medical attention immediately by calling 911 if you or someone taking loperamide experiences any of the following, and tell health care professionals the person has been taking loperamide:
Rapid heartbeat or irregular heart rhythm
Unresponsiveness, meaning that you can't wake the person up or the person doesn't answer or react normally
Health care professionals should be aware that using much higher than recommended doses of loperamide, either intentionally or unintentionally, can result in serious cardiac adverse 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. Some individuals are taking high doses of loperamide to treat symptoms of opioid withdrawal. If loperamide toxicity is suspected, promptly discontinue the drug and start necessary therapy. For some cases of abnormal heart rhythms in which drug treatment is ineffective, electrical pacing or cardioversion may be required. Also counsel patients to take loperamide only as prescribed or according to the OTC Drug Facts label and advise patients that drug interactions with commonly used medicines may increase the risk of serious cardiac events.
For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
Loperamide may cause serious or life-threatening changes in your heart rhythm, especially in people who have taken more than the recommended amount. Tell your doctor if have or have ever had a prolonged QT interval (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death), a slow or irregular heartbeat, or a low level of potassium in your blood. Also tell your doctor if you are taking or plan to take any of the following medications: amiodarone (Nexterone, Pacerone), chlorpromazine, haloperidol (Haldol), methadone (Dolophine, Methadose), moxifloxacin (Avelox), pentamidine (Nebupent, Pentam), procainamide, quinidine (in Nuedexta), sotalol (Betapace, Betapace AF), thioridazine, and ziprasidone (Geodon). Your doctor will probably tell you not to take loperamide if you are taking any of these medications or if you have any of these conditions. If you experience any of the following symptoms while taking loperamide, call your doctor immediately: fast, irregular, or pounding heartbeat; dizziness; lightheadedness; unresponsiveness; or fainting.
Taking more than the recommended amount of loperamide can cause heart problems that may be serious or cause death. Do not take a larger dose, take it more often, or take it for a longer period of time than prescribed by your doctor or as stated on the package.
Loperamide should not be given to a child younger than 2 years of age because of the risk of serious breathing and heart problems.