The Food and Drug Administration ordered about 500 prescription cold, cough and allergy medications off the market earlier this week because the drugs lacked FDA approval, meaning that they have not been subjected to complete safety, quality, and efficacy testing by the agency.
The recalled medicines (see the full list here) contained 27 different active ingredients and fall into one of three categories: products in extended release form, those that contain tannates salts as active ingredients, and certain immediate release products. Most are not common household names, and none have been linked to any serious side effects (most adverse events linked to these drugs were sedation, drowsiness and irritability linked to decongestants and antihistamines). There are no over-the-counter drugs included in this recall.
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The FDA is particularly concerned about their continued presence in the market for a few reasons:
• Despite the 2008 FDA warning against the use of OTC cough and cold products for children under the age of 2 because of potentially life-threatening side effects, some of these medications remain labeled for use by children under the age of 2, although they contain the same ingredients in the OTC products that were voluntarily relabeled for kids 4 and older
• Some medications contain a combination of the same kinds of drugs, raising the risk of over-medication
• Some drugs are marketed as time-release formulas, but they either deliver the vast majority of the medicine immediately after consumption (instead of during a longer window, as expected) or they fail to deliver most of the medicine promised
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The FDA asked companies to stop manufacturing these products within 90 days and stop shipping them within 180 days, although certain manufacturers must halt making and shipping their products immediately.
So, how did these drugs lacking FDA approval make it onto pharmacy shelves? It’s pretty simple: either the medicines were grandfathered in because they went on sale prior to a 1962 law that required the FDA to confirm a drug’s safety and effectiveness before it went on the market, or certain manufacturers simply bypassed the FDA and took their drugs straight to market, according to Time.
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Unfortunately, according to the FDA, many doctors have prescribed these drugs for years without knowing that they were never approved, meanwhile assuming that because they’ve remained on the market for so long, they must be safe. And a number of the medicines show up on drug registries and are even approved by insurance drug plans, which is part of why the FDA created the Unapproved Drugs Initiative in 2006 to make drug manufacturers comply with current approval regulations or stop selling their products (this is the 17th action on a drug class by this initiative).
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If you are taking a prescription medication for cough, cold, or allergy symptoms and want to confirm that it is indeed FDA-approved, you can check out the following resources from the FDA: (Note: as OTC products don’t require FDA approval, they will not appear on these lists.)
•Drugs@FDA (contains most, although not all, FDA-approved drug products): If a product or active ingredient is not included here, the search results will say “Your search term did not return any results.”
• 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 new drug application (NDA) number or abbreviated new drug application (ANDA) number in this column.
•The Orange Book List of Approved Drug Products: If a product or active ingredient is not approved, the search results will say, "No matching records found."
Consumers and health care professionals are encouraged to report adverse side effects or medication errors from the use of unapproved prescription cough, cold, and allergy products to the FDA's MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 800-332-1088.