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:1/18/2017)... -- After the recent election cycle, it is ... both for medical and recreational purposes are shifting. The evidence ... use of cannabis, but the focus is coming from both ... the North American legal cannabis market posted $6.7 billion in ... research projects sales will grow at a compound annual growth ...
(Date:1/18/2017)... TOKYO , Jan. 18, 2017  Astellas ... , "Astellas" ) today announced its participation in ... access to non-communicable disease (NCD) prevention, diagnostics and ... with 21 other leading pharmaceutical companies and in ... Union for International Cancer Control (UICC), Astellas will ...
(Date:1/17/2017)... , Jan. 17, 2017 Precision medicine ... for the treatment of disease. The approach allows ... to a therapy. The approach studies the individual ... lifestyle and environment. In January 2015, Precision Medicine ... to all diseases with more than one million ...
Breaking Medicine Technology:
(Date:1/18/2017)... ... ... From a health perspective, 2017 will clearly be the Year of the Gut. ... health and general physical well-being. The New York Times suggested a “ Gut Makeover ... Charlottesville restaurant, good gut health is clearly on the menu. Threepenny Cafe ...
(Date:1/18/2017)... , ... January 18, 2017 , ... The V Foundation ... Team V, its official endurance training and fundraising team, to compete in the Boston ... welcomes those inspired to finish the world’s oldest annual marathon to join Team V ...
(Date:1/18/2017)... ... 2017 , ... At Hallmark Nameplate, their commitment to quality is what sets ... ISO 13485. This certification is another way they are making constant strides to provide ... they need. , The ISO 13485 Certification is a major accomplishment for Hallmark Nameplate ...
(Date:1/18/2017)... ... January 18, 2017 , ... Rollerblade®, the worldwide ... (ABT), an innovative braking system that allows skaters of all levels to stop ... the biggest concerns of beginner and intermediate skaters – learning how to brake ...
(Date:1/17/2017)... ... , ... Gym Source, America’s leading retailer of premium residential and commercial fitness ... Miami, FL. , “We are elated to be opening this new showroom,” explains Tom ... to give clients a seamless and motivating shopping experience.” , Every fitness journey is ...
Breaking Medicine News(10 mins):