Warning on Unapproved Antitussives Containing Hydrocodone

Posted on April 29, 2008

FDA is taking action against companies that market unapproved drugs containing hydrocodone, a controlled substance. Hydrocodone is a narcotic widely used as an analgesic in approved products such as Vicodin. It is also used as a cough suppressant. The vast majority of these antitussive products have not been approved.

Despite its potential for medical benefit, hydrocodone is a potentially lethal drug of abuse. Overdose can lead to cardiac arrest, coma and respiratory failure. FDA is particularly concerned about the use of unapproved hydrocodone cough medicines in children. No hydrocodone cough suppressant has been shown safe and effective for children under six, and yet some of these unapproved products have dosing instructions for children as young as two.

Also, FDA has received reports of medication errors associated with changes in the formulation of unapproved hydrocodone products, as well as name confusion between approved and unapproved ones.

There are seven FDA-approved antitussives that contain hydrocodone, and a variety of other approved cough suppressants without it. Providers should be certain that the antitussives they recommend to their patients are FDA-approved.

Additional Information:

FDA MedWatch Safety Alert. Hydrocodone in Unapproved Prescription Products. September 28, 2007.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Hydrocodone