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FDA Prompts Removal of Unapproved Drugs from Market


Yesterday, the U.S. Food and Drug Administration (FDA) announced its intention to remove certain unapproved prescription medicines intended to relieve cough, cold, and allergy symptoms from the U.S. market.

Unapproved prescription cough, cold, and allergy drug products have not been evaluated by the FDA for safety, effectiveness, and quality. People may be at greater risk when using these products than when using FDA-approved prescription drugs or drugs that are appropriately marketed over-the-counter (OTC).

FDA officials say they have numerous concerns about these products. One concern is that some may have potentially risky combination of ingredients, while others—marketed as “timed-release”—may release active ingredients too slowly, too quickly, or inconsistently.

Additionally, the FDA has received reports that some of the products have names that look or sound similar to other products—a problem that could contribute to medication errors.

FDA health experts are also concerned that some of the products are inappropriately labeled for use by infants and young children. Many of the unapproved drug products covered by today’s announcement contain the same ingredients as the OTC cough and cold products that were the subject of a 2008 FDA public health advisory.

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That 2008 advisory said non-prescription cough and cold products should not be used for infants and children under 2 years of age 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 under 4 years old.

“Removing these unapproved products from the market will reduce potential risks to consumers,” said Deborah Autor, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “There are many FDA-approved prescription products, as well as appropriately marketed over-the-counter products, available to treat cough, cold, and allergy symptoms; so, we expect little or no negative impact on consumers from the removal of these unapproved products.”
Companies that have previously listed products subject to today’s action with FDA are expected to stop manufacturing them within 90 days and stop shipping the products within 180 days. Companies that have not previously listed products subject to today’s action with FDA are expected to stop manufacturing and shipping their products immediately.

Given that so many cough, cold, and allergy drug products exist that are FDA-approved prescription products or are appropriately marketed OTC, taking an unapproved prescription product is an unnecessary risk.

This is the 17th action on a drug class as part of FDA's Unapproved Drugs Initiative, which began in June 2006. The initiative is the agency’s risk-based enforcement approach to efficiently and rationally bring all unapproved new drugs into the approval process. One of the goals of the initiative is to reduce consumer exposure to drugs that are not proven safe, effective, and of high quality.

More information is available:

  1. Unapproved Prescription Cough, Cold, and Allergy Products Federal Register Notice (PDF)
  2. List of Unapproved Prescription Cough, Cold, and Allergy Drug Products Affected by Today’s Action, Based on Firm's Listing with FDA
  3. Unapproved Drugs Enforcement Actions (By Drug Class)
  4. Consumer Health Update: FDA Intends to Remove Unapproved Drugs from the Market (March 2, 2011)

Food and Drug Administration