FDA is warning consumers about the threat of serious bleeding as soon as using over-the-counter aspirin-containing antacid assets to law heartburn. The company also authorize a separate warning around loperamide (Imodium, Johnson & Johnson), saying that abuse or misuse the the product can reason serious heart troubles that deserve to lead come death.

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FDA is warning consumers around the threat of serious bleeding when using over-the-counter aspirin-containing antacid products to act heartburn. The company also authorize a different warning about loperamide (Imodium, Johnson & Johnson), saying the abuse or misuse that the product can reason serious heart problems that can lead come death.

“These widely-used products currently contain warnings around this bleeding risk on their labels; however, we are proceeding to obtain reports that this serious safety and security issue,” FDA said in a Drug safety Communication around aspirin-containing antacids. “As a result, we will continue to evaluate this safety and security concern and plan to convene an advisory committee that external professionals to administer input about whether extr FDA actions room needed.”

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Aspirin-containing antacids include Alka-Seltzer Original, Bromo Seltzer, Medique Medi Seltzer, Picot add to Effervescent, Vida Mia pains Relief, Winco foodstuffs Effervescent Antacid and also Pain Relief, Zee-Seltzer Antacid and also Pain Reliever, along with their share counterparts.

Several OTC antacids that carry out not save on computer aspirin space available, FDA pointed out.

While, every OTC assets that save NSAIDs, consisting of aspirin-containing antacids, were compelled to include a warning about the hazard of serious bleeding in 2009, FDA’s Adverse occasion Reporting mechanism (FAERS) database determined eight cases of significant bleeding events linked with these commodities after the warning to be added.

“All of these patients were hospitalized. Patients had underlying conditions such as the hazard factors above that put them at better risk for occurring serious bleeding events,” FDA said.

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In FDA’s warning around loperamide, the firm said that serious heart problems, consisting of abnormal heart rhythms, may be raised when high doses of loperamide are taken with number of kinds of medicines that connect with loperamide. This drugs include cimetidine (Tagamet HD) and ranitidine (Zantac).

“The bulk of reported major heart problems emerged in individuals who were deliberately misusing and abusing high doses of loperamide in attempts come self-treat opioid withdrawal symptom or to accomplish a emotion of euphoria,” FDA said.

 In instances of abuse, individuals regularly use other drugs together with loperamide in do the efforts to increase its absorption and penetration across the blood-brain barrier and also enhance its euphoric effects, according to FDA.

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“Health treatment professionals should be mindful that use of higher-than-recommended sheep of loperamide can an outcome in significant cardiac adverse events. Take into consideration loperamide as a feasible cause of unusual cardiac events including QT term prolongation, Torsades de Pointes or various other ventricular arrhythmias, syncope and also cardiac arrest,” FDA said.