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:6/26/2016)... VEGAS , June 26, 2016 ... to value-based care operating models within the health care ... enable greater financial efficiency , Deloitte offers a ... the key business issues impacting efficient cost optimization: labor ... , These services facilitate better outcomes and better ...
(Date:6/24/2016)... , June 24, 2016 ... has announced the addition of the " Global ... This report ... provides an updated review, including its applications in various ... total market, which includes three main industries: pharmaceutical and ...
(Date:6/24/2016)... -- Research and Markets has announced the addition ... report to their offering. ... The World Market for Companion Diagnostics covers the world ... in the report includes the following: , ... by Region (N. America, EU, ROW), 2015-2020 , World ...
Breaking Medicine Technology:
(Date:6/25/2016)... TX (PRWEB) , ... June 25, 2016 , ... ... the United States, named Dr. Sesan Ogunleye, as the Medical Director of its new ... the facility Medical Director of our new Mesquite location,” said Dr. James M. Muzzarelli, ...
(Date:6/25/2016)... , ... June 25, 2016 , ... ... and non-athletes recover from injury. Recently, he has implemented orthobiologic procedures as a ... area —Johnson is one of the first doctors to perform the treatment. Orthobiologics ...
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits ... terms of the latter, setting the bar too high can result in disappointment, perhaps ... slow progress toward their goal. , Research from PsychTests.com reveals that ...
(Date:6/24/2016)... ... ... Those who have experienced traumatic events may suffer from a complex set ... drug or alcohol abuse, as a coping mechanism. To avoid this pain and suffering, ... traumatic event. , Trauma sufferers tend to feel a range of emotions, from depression, ...
(Date:6/24/2016)... ... ... was in a crisis. Her son James, eight, was out of control. Prone to extreme ... “When something upset him, he couldn’t control his emotions,” remembers Marcy. “If there was ... other children and say he was going to kill them. If we were driving ...
Breaking Medicine News(10 mins):