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Managing Cough in the Aftermath of the Decision of the US Food and Drug Administration to Remove Unapproved Prescription Cough Medications From the MarketManagement of Cough Post FDA Action on Medication

Richard S. Irwin, MD, Master FCCP; Brian S. Smith, PharmD
Author and Funding Information

From the UMass Memorial Medical Center and the Editorial Office of CHEST (Dr Irwin); and the Department of Pharmacy, UMass Memorial Medical Center (Dr Smith).

Correspondence to: Richard Irwin, MD, Master FCCP, Pulmonary, Allergy, and Critical Care Medicine Division, UMass Memorial Medical Center, 55 Lake Ave N, Worcester, MA 01655; e-mail: Richard.Irwin@umassmemorial.org


Financial/nonfinancial disclosures: The authors have reported to CHEST the following conflicts of interest: Dr Irwin is Editor in Chief of the Journal. Although not employed by the American College of Chest Physicians, a portion of Dr Irwin’s salary comes from the College as a stipend. Drs Irwin and Smith have reported that no potential conflicts of interest exist with any companies/organizations whose products or services may be discussed directly or indirectly in this article.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (http://www.chestpubs.org/site/misc/reprints.xhtml).


© 2011 American College of Chest Physicians


Chest. 2011;140(2):282-284. doi:10.1378/chest.11-1414
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Extract

On March 3, 2011, the US Food and Drug Administration (FDA)1 announced that companies that manufacture, distribute, or market approximately 500 unapproved prescription oral cough, cold, and allergy drugs must cease doing so. Although companies that were not listed with the FDA had to stop manufacturing and shipping such drugs immediately, those companies listed with the FDA had to stop manufacturing the unapproved drugs by June 3, 2011, and shipping by September 3, 2011. The reasons the FDA took this action are stated in the comprehensive Commentary by Ostroff et al2 in this issue of CHEST (see page 295). In short, because none of the banned medications had undergone the safety and effectiveness evaluation process of the FDA, the FDA could not be certain how they were manufactured, what was contained within them, or whether they would work as advertised. We applaud the FDA for taking this action and for contacting us, the developers and publishers of the American College of Chest Physicians (ACCP) Cough Guidelines,3 before their announcement to learn if we thought that there might be any potential unintended consequences of their action on managing patients with cough.

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