FDA Eyeing Unapproved Cough Suppressants
FDA to Crack Down on Unapproved Drugs Containing Hydrocodone, Including 200 Cough Suppressants
Sept. 28, 2007 -- The FDA plans to crack down on unapproved prescription
drug products -- including some 200 cough suppressants -- containing
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
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.
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
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.
Anyone marketing unapproved hydrocodone products that are currently labeled
for use in children younger than 6 years of age must end further manufacturing
and distribution of the products on or before Oct. 31, 2007.
Those marketing any other unapproved hydrocodone drug products must stop
manufacturing such products on or before Dec. 31, 2007, and must cease further
shipment in interstate commerce on or before March 31, 2008.
Failure to heed those deadlines may draw FDA enforcement.