FDA cracks down on hydrocone products

Sep 29, 2007

The U.S. Food and Drug Administration says it will start taking enforcement action against companies marketing unapproved hydrocodone products.

About 200 cough-suppressant products on the market will be impacted, the FDA said Friday in a release.

Hydrocodone, a narcotic widely used to treat pain and suppress coughs, can lead to serious illness, injury or death if improperly used.

While some hydrocodone-relief products such as Vicodin are FDA-approved, most hydrocodone formulations now marketed to suppress coughs are not.

The agency said it is especially concerned about improper pediatric labeling of unapproved hydrocodone cough suppressants, and the risk of medication error involving the unapproved products. Dr. Steven K. Galson, director of the FDA's Center for Drug Evaluation and Research, said no hydrocodone cough suppressant has been established as safe and effective for children under 6.

Copyright 2007 by United Press International

Explore further: Outcomes of lung transplantations since implementation of need-based allocation system

add to favorites email to friend print save as pdf

Related Stories

Recommended for you

Uganda on defensive over medical 'brain drain' uproar

6 hours ago

Uganda's government on Tuesday hit back at mounting criticism of plans to 'export' over 200 health workers to the Caribbean, insisting it was only seeking to regulate an existing labour market and prevent abuses.

Seth Mnookin on vaccination and public health

Mar 02, 2015

Seth Mnookin, an assistant professor of science writing and associate director of MIT's Graduate Program in Science Writing, is the author of "The Panic Virus: The True Story Behind the Vaccine-Autism Controversy" ...

User comments : 0

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.