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FDA Issues Heart Warning on Imodium
The FDA has warned that taking higher-than-recommended doses of the common over-the-counter (OTC) and prescription diarrhea medication loperamide (Imodium), including through abuse or misuse of the product, can cause serious heart problems, including abnormal heart rhythms, that can lead to death.
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The primary ingredient in the drugs, loperamide, is meant to control diarrhea. In the 39 years since loperamide was approved, the FDA got reports of 48 cases of serious heart problems-10 of them fatal-connected to the drug.
For an adult, that maximum amount is 8 mg a day for the over-the-counter version or 16 mg a day for the version available by prescription.
The United States Food and Drug Administration (FDA) on Tuesday said that a lot many people are increasingly overdosing on an anti-diarrhea drug which has similar effects of opiate drugs.
One study said that calls to poison centers related to loperamide abuse increased by 71 percent from 2011 through 2014.
RECOMMENDATION: Health care professionals should be aware that use of higher than recommended doses of loperamide can result in serious cardiac adverse events. Furthermore, if toxicity is suspected, loperamide should be discontinued immediately and any patient experiencing diarrhea for more than two days should discontinue the drug and contact their healthcare provider.
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The FDA advised doctors to consider loperamide as a possible explanation in cases of certain abnormally fast heart-rhythm disturbances known as ventricular arrhythmias, as well as in cases of fainting and of cardiac arrest. In the cases of abuse, people often use other drugs with loperamide with an aim to increase its absorption and helps in enhancing euphoric effect. Medical literature that the FDA has received shows that though recommended dosage ranges from 8mg to 16 mg, abusers have taken inordinate doses of up to 300 mg at once. According to reports, numerous overdose cases are accidental, however there are new reports of people taking these drugs as a substitute to curb the cravings of highly-addictive opioid drugs. In some cases, opioid abusers will attempt to wean themselves off those drugs by substituting the anti-diarrhea drugs. FDA continues to evaluate this safety issue and will determine if additional FDA actions are needed.