FDA Moves In On Unapproved Cough Suppressant Hydrocodone Products

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Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Respiratory / Asthma;  Pediatrics / Children's Health;  Pain / Anesthetics
Article Date: 29 Sep 2007 - 8:00 PDT

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The U.S. Food and Drug Administration (FDA) is taking action on approximately 200 cough-suppressant products, many of which are mistakenly being given to children. Hydrocodone is a narcotic commonly used for the treatment of pain and suppressing coughs. The FDA informs that this action should not involve other FDA approved formulations.

Apart from being a strong pain medication and strong cough suppressant, hydrocodone has also been a very widespread drug of abuse, which can cause severe illness, injury, and even death, if used incorrectly. Hydrocodone overdosing is closely linked to cardiac arrest, breathing problems, and impaired motor skills and judgement.

The Agency states that it has received reports of medication errors linked to formulation changes in unapproved hydrocodone drugs. It has also received reports of confusion over the similarity of names of unapproved and approved drug products.

The FDA is concerned about the possible medication errors and name confusion. It stresses that potential safety issues associated with these factors must be minimized.

Vicodin is an FDA-approved hydrocodone pain relief drug. However, the majority of hydrocodone formulations currently on the market as cough suppressants do not have FDA approval. The FDA is very concerned about improper pediatric labeling of hydrocodone cough suppressants that have not been FDA-approved.

Steven K. Galson, M.D., M.P.H., Director, Center for Drug Evaluation and Research (CDER), FDA, said "Companies marketing these unapproved products have not demonstrated the safety and efficacy of these drugs. 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."

In June 2006 the FDA published a Compliance Policy Guide which describes the FDA's risk-based enforcement approach to these products. The FDA says that today's action is part of the Agency's broader initiative on marketed unapproved products.

Deborah M. Autor, J.D., Director, CDER's Office of Compliance, FDA, said "This is another example of the kinds of safety risks that warrant priority enforcement under our Compliance Policy Guide. There are products on the market with inadequate safety information on their labeling improperly suggesting that the products may be used safely by very young children. In addition, these products may pose a higher risk of medication error than approved products. These products need to come off the market until they meet FDA approval standards."

For patients looking for alternatives to unapproved hydrocodone cough suppressants, the Agency points out that there are seven FDA-approved cough suppressant (antitussive) medications containing hydrocodone. There are several antitussive products which do not contain hydrocodone. For detailed guidance on treatment options the FDA advises patients to consult with a health care professional.

The FDA is telling anyone who markets unapproved hydrocodone products labeled for use in children under 6 to stop doing manufacturing and distributing them by October 31st, 2007.

-- Hydrocodone Drug Products Information

Written by: Christian Nordqvist
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