Warning Issued About Hydrocodone and Children's Cough Suppressants

In 2006, over 130 million prescriptions were written for products containing hydrocodone, according to the Branded Pharmaceutical Association (BPA). The U.S. Food and Drug Administration (FDA) has announced that it will take enforcement action to stop the marketing of some 200 unapproved medications containing hydrocodone.

Some of the 200 unapproved products are being marketed as children's cough suppressants with labels that omit important warnings for young children. Hydrocodone has NOT been proven safe for children under 6 years old, yet some companies label their product for use with children 2 years old and up. Firms must stop making and distributing products on or before October 31, 2007, that are labeled for use in children under the age of 6. Firms marketing any unapproved hydrocodone drug products that are not labeled for use in children under 6 must stop manufacturing new product on or before December 31, 2007.

Adverse reports about unapproved hydrocodone products include errors in dosing and dispensing the wrong drug. Hydrocodone is a powerful opioid derived from codeine that is used in pain medications and cough suppressants (antitussives). The FDA has approved most of the pain medications using hydrocodone, like Vicodin. However, some of the unapproved medications have mixed hydrocodone with other substances and/or have omitted warnings about using hydrocodone with other substances that can prove fatal or have not been tested for safety.

There are a number of antitussives on the market, both over-the-counter and prescription that do not include hydrocodone. Consumers should seek expert guidance from a healthcare professional about which are best to use. The FDA-approved antitussive products containing hydrocodone are: TUSSICAPS, TUSSIONEX PENNKINETIC, HYDROCODONE COMPOUND, MYCODONE, HOMATROPRINE METHYLBROMIDE AND HYDROCODONE BITARTRATE, HYCODAN, and TUSSIGON.

The FDA found that in 2005, 17 million Americans, aged 12 and older, used a hydrocodone pain reliever for non-medical purposes, at least once in their life. 8 million of those Americans had used hydrocodone for non-medical purposes within the past 12 months. Misuse of hydrocodone can be lethal or result in coma, cardiac arrest, respiratory depression and other life-threatening side effects.

Adverse effects most often reported for hydrocodone products are with: the central nervous system, including psychotic behavior and drug abuse; the gastrointestinal tract, including nausea, vomiting, and constipation; the cardiopulmonary system, including cardiac arrest and respiratory depression; hypersensitivity, including pruritis, dermatitis, and pharyngeal edema; and intentional and unintentional overdose.

Sources:

FDA Takes Action to Stop Marketing of Unapproved Hydrocodone Products
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01713.html

The Branded Pharmaceutical Association Comments on Hydrocodone
http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/09-28-2007/0004672393&EDATE=