US FDA Details Trials To Evaluate New Drugs' Potential Interactions With Heartburn Remedies

Concerns In Draft Guidance Are Second Strike Against Heartburn Drugs In A Year

Draft guidance on testing investigational drugs for drug-drug interactions with ingredients used in antacids, histamine H2-receptor antagonists and proton pump inhibitors points to including labels warnings on the new drugs about their concomitant use with the heartburn remedies.

A year after a common heartburn ingredient was linked to a contaminant and worldwide recalls followed, concerns have emerged in the US that products in the category could weaken the efficacy of other drugs or cause adverse events when used at the same time.

A Food and Drug Administration draft guidance on testing investigational drugs for drug-drug interactions (DDIs) with ingredients used in...

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