Navigation Links
FDA Prompts Removal of Unapproved Drugs From Market
Date:3/2/2011

SILVER SPRING, Md., March 2, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today took action against companies that manufacture, distribute, or market certain unapproved prescription oral cough, cold, and allergy products. The affected products cannot be legally marketed in the United States.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

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).  

Many health care providers are unaware of the unapproved status of drugs and have continued to unknowingly prescribe them because the drugs' labels do not disclose that they lack FDA approval.

"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.  

Consumers who believe they are taking an unapproved prescription cough, cold, or allergy product should contact their health care provider to discuss alternatives.  

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.  

Consumers and health care professionals are encouraged to report adverse side effects or medication errors from the use of unapproved prescription cough, cold, and allergy products to the FDA's MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 800-332-1088.


Media Inquiries: Shelly Burgess, 301-796-4651; shelly.burgess@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Leading Denture Cream Litigation Firm Welcomes GSK Announcement of Removal of Zinc From Its Denture Creams
2. Romeo and Juliette Laser Hair Removal Is First Center in New York City to Own Cynosures New Elite MPX(TM) Laser System
3. WIFH Atlanta Announces Breakthrough Technique in Laser Hair Removal for Ethnic Skin Types
4. Myelin Removal Beads: Premium Efficiency for Neural Cell Separations and Antibody Stainings
5. AUA Guideline: Full Kidney Removal Not Necessary for All Kidney Tumors
6. Gallbladder Removal Through Vagina Offers Minimally Invasive Alternative
7. September 2008 Mayo Clinic Health Letter Highlights Cataract Removal, Severe Headache and Dual Energy X-Ray Imaging
8. Novare Announces Completion of First Pediatric Single Port Spleen Removal Using RealHand(R) HD Instruments
9. Applisonix Announces Breakthrough in Ultrasound Technology for Hair Removal - Average Hair Reduction of 38% Following Initial Treatment
10. FDA Consumer Health Information - FDA Tightens Reins on Unapproved Chelation Drugs
11. FDA Issues Warnings to Marketers of Unapproved Chelation Products
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/22/2017)... India , February 22, 2017 According ... Product (Scissors, Forceps, Trocar, SIMS, CUSCO), Application (Laparoscopy, Colposcopy, Hysteroscopy, D&C, ... Global Forecast to 2021", published by MarketsandMarkets, the global market is ... Billion in 2016, at a CAGR of 7.1% during the forecast ... ...
(Date:2/22/2017)... DUBLIN , Feb 22, 2017 ... "Dermatology Therapeutics Drug Development Pipeline Review, 2016" report to ... ... types of disorders worldwide, and approximately one-third of the US ... the past decades, the majority of the dermatology market has ...
(Date:2/22/2017)... A research report by Arcview Market Research ... and the continuously changing landscape of the legal market reveals that ... North America , a 30% increase from 2015. According ... by the year 2021 representing a 26 percent compound annual growth ... and Canada is gradually becoming ...
Breaking Medicine Technology:
(Date:2/22/2017)... Jacksonville, Fla. (PRWEB) , ... February 22, 2017 ... ... aneurysms is just as effective on smaller and sometimes harder to reach ones, ... findings were presented at the International Stroke Conference in Houston by Ricardo A. ...
(Date:2/22/2017)... , ... February 22, 2017 ... ... of their newest advanced absorption cannabidiol (CBD) serum, “NANOCALM 300” Microemulsified Hemp ... which provides instant absorption from the mouth into the bloodstream. Far ...
(Date:2/22/2017)... ... February 22, 2017 , ... ANGLESTRONG , the new recovery management ... on the App Store and Google Play . Florida-based Sober Network, ... and recovery industry, partnered with Angle to build ANGLESTRONG. The new recovery management app ...
(Date:2/22/2017)... ... February 22, 2017 , ... Bellus Medical, ... latest innovation in the delivery of Platelet Rich Plasma (PRP). PRP systems are ... management, to accelerate tissue synthesis and provide a faster and more efficient healing ...
(Date:2/22/2017)... ... February 22, 2017 , ... Forty-five ... of those report that family members or friends have also commented about their ... hearing loss wear hearing aids. One reason, suggested by 89 percent of American ...
Breaking Medicine News(10 mins):