FDA to remove unapproved cough and cold medicines
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The Food and Drug Administration plans to remove some unapproved prescription cough, cold and allergy medicines now sitting on store shelves, the agency announced Wednesday.
The products, which may be inappropriately labeled for use by infants and young children, could pose an unnecessary risk because they haven’t been tested for safety and efficacy, the FDA said. Some may have risky ingredients, and others -- marketed as ‘timed release’ -- may release active ingredients too slowly, too quickly or inconsistently.
Some products have names that look or sound similar to other products -- a problem that could contribute to medication errors.
Many of the unapproved drug products that the FDA plans to remove from the market contain the same ingredients as the over-the-counter cough and cold products that were the subject of a 2008 FDA public health advisory.
In that case, the FDA warned that non-prescription cough and cold products should not be used for infants and children younger than 2 because of serious and potentially life-threatening side effects.
Many manufacturers voluntarily withdrew products labeled for children under 2 years old, and some products were relabeled to state that they were not for use by children younger than 4.
If you’re taking a drug and want to know whether it’s approved, use one of these FDA resources:
Drugs at FDA (contains most FDA-approved drug products): If a product is not included here, the search results will say, “Your search term did not return any results.”
The Orange Book List of Approved Drug Products: If a product is not FDA approved, the search results will say, “No matching records found.”
The National Drug Code (NDC) Directory of prescription drugs and insulin products: Search results include a column marked “Appl No.” FDA-approved products will have an associated NDA (new drug application) or ANDA (abbreviated new drug application) number in this column.
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