Skip to content

Cold, Flu, & Cough Health Center

FDA Eyeing Unapproved Cough Suppressants

FDA to Crack Down on Unapproved Drugs Containing Hydrocodone, Including 200 Cough Suppressants
Font Size
A
A
A
By
WebMD Health News
Reviewed by Louise Chang, MD

Sept. 28, 2007 -- The FDA plans to crack down on unapproved prescription drug products -- including some 200 cough suppressants -- containing hydrocodone.

Hydrocodone is a narcotic widely used to treat pain and suppress coughs. The FDA is particularly concerned about unapproved hydrocodone cough suppressants (antitussives) marketed for kids, as well as the risk of medication errors involving unapproved products.

Today, the FDA announced deadlines for companies to stop marketing unapproved hydrocodone products. FDA-approved hydrocodone drugs including the painkiller Vicodin aren't affected.

Consumers have some alternatives to unapproved hydrocodone cough suppressants.

The FDA says the approved products are: Tussicaps by Tyco Healthcare, Tussionex Pennkinetic by UCB Inc., Hydrocodone Compound by Actavis Mid Atlantic, Mycodone by Morton Grove, Homatropine Methylbromide and Hydrocodone Bitartrate by Actavis Totowa, Hycodan by Endo Pharms, and Tussigon by King Pharmaceuticals.

There also are various FDA-approved antitussive products that don't contain hydrocodone. The FDA advises consumers to consult a health care professional for detailed guidance on treatment options.

About Hydrocodone

Hydrocodone is one of the strongest medications available to treat pain or to suppress cough.

The drug has also been an extremely popular drug of abuse and can lead to serious illness, injury, or death, if improperly used. Hydrocodone overdose can result in breathing problems or cardiac arrest, and its use may impair motor skills and judgment.

The FDA has received reports of medication errors associated with formulation changes in unapproved hydrocodone products and reports of confusion over the similarity of the names of unapproved products to approved drug products.

As part of the drug approval process, the FDA considers the possibility of medication errors and name confusion, so that potential safety issues associated with these factors can be minimized.

Approved Drugs Not Affected

Some hydrocodone pain-relief products are FDA-approved. But most hydrocodone formulations marketed to suppress coughs haven't been approved by the FDA.

"Companies marketing these unapproved products have not demonstrated the safety and efficacy of these drugs," the FDA's Steven Galson, MD, MPH, says in a news release.

"A case in point -- no hydrocodone cough suppressant has been established as safe and effective for children under 6 years of age and some of these unapproved products carry labels with dosing instructions for children as young as 2 years of age," says Galson, who directs the FDA's Center for Drug Evaluation and Research.

Today on WebMD

hot toddy
15 tips to help you feel better.
man sneezing into elbow
Do echinacea and vitamin C really help a cold?
 
teen girl coughing
Get a good night’s rest with these remedies.
elder berry
Eat these to fight colds, flu, and more.
 
Natural Cold Flu Remedies Slideshow
Slideshow
cold weather
VIDEO
 
Allergy And Sinus Symptom Evaluator
Article
Boy holding ear
Slideshow
 

Loaded with tips to help you avoid food allergy triggers.

Loading ...

Sending your email...

This feature is temporarily unavailable. Please try again later.

Thanks!

Now check your email account on your mobile phone to download your new app.

woman receiving vaccine shot
Article
woman with fever
Article
 
Waking up from sleep
Article
woman with sore throat
Slideshow