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Health Agencies Update
April 27, 2011

Unapproved Drugs Pulled

JAMA. 2011;305(16):1646. doi:10.1001/jama.2011.536

The US Food and Drug Administration (FDA) has ordered the makers of more than 500 unapproved cold, cough, and allergy products to remove their products from the market.

The order, announced March 2, will require manufacturers to stop making the products within 90 days and to stop shipping them within 180 days. The products include both prescription and over-the-counter remedies, many containing ingredients commonly used in FDA-approved products for these indications. However, the cited products have never undergone the processes required by the FDA to ensure safety and efficacy. For example, some of these drugs became available prior to a 1962 law required the FDA to assess a drug's safety and effectiveness before it could be sold to the public. Many clinicians may be unaware that the products, many of which have been on the market for years, have not undergone such assessment. A list of the products is available online (http://tinyurl.com/48xj7th).

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