facebook
twitter
rss
account
search
search
 

FDA cracks down on unapproved drugs

June 8, 2006 at 10:24 AM   |   Comments

WASHINGTON, June 8 (UPI) -- The Food and Drug Administration said Thursday it was strengthening its efforts against unapproved drug products.

The FDA, which estimated there are several hundred unapproved active ingredients in prescription drugs on the market, issued a new guidance that encourages companies marketing unapproved drugs to seek agency approval.

"Right now, many unapproved drugs represent a public health threat because consumers wrongly assume that these widely marketed and available drugs are approved and have been found to be safe and effective by the FDA," said Acting FDA Commissioner Andrew von Eschenbach.

The FDA said its first action would be focused on unapproved prescription products containing the antihistamine carbinoxamine.

Many unapproved carbinoxamine products are labeled for treatment of cough and cold symptoms, which is not an FDA approved indication for the compound. These products often are specifically labeled for use in young children, but this raises safety concerns because the drug has never been studied in this age group, the FDA said.

© 2006 United Press International, Inc. All Rights Reserved. Any reproduction, republication, redistribution and/or modification of any UPI content is expressly prohibited without UPI's prior written consent.
Recommended UPI Stories
Featured UPI Collection
trending
Notable deaths of 2014 [PHOTOS]

Notable deaths of 2014 [PHOTOS]

Most Popular
1
To breakfast or not to breakfast? That is the question...
2
New data shows Melbourne is most well-rested city in the world
3
Daughters more likely than sons to care for elder parents
4
India asks Pepsi to cut down on sugar in its soft drinks
5
Yoga guru BKS Iyengar dies at 95
Trending News
Video
x
Feedback