Fda Eyeing Crooked Ahem Suppressants
The FDA affairs to able down on crooked prescription drug articles -- including some 200 ahem suppressants -- containing hydrocodone.
Hydrocodone is a analgesic broadly acclimated to amusement affliction and suppress coughs. The FDA is decidedly anxious about crooked hydrocodone cough suppressants (antitussives) marketed for kids, as able-bodied as the accident of medication errors involving crooked products.
Today, the FDA appear deadlines for companies to stop marketing unapproved hydrocodone products. FDA-approved hydrocodone drugs including the painkiller Vicodin aren't affected.
Consumers accept some alternatives to crooked 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 aswell are assorted FDA-approved antitussive articles that don't contain hydrocodone. The FDA advises consumers to argue a bloom affliction professional for abundant advice on analysis options.
About Hydrocodone
Hydrocodone is one of the arch medications accessible to amusement affliction or to abolish cough.
The biologic has aswell been an acutely accepted biologic of corruption and can advance to serious illness, injury, or death, if break used. Hydrocodone balance can result in breath problems or cardiac arrest, and its use may blemish motor skills and judgment.
The FDA has accustomed letters of medication errors associated with formulation changes in crooked hydrocodone articles and letters of confusion over the affinity of the names of crooked articles to accustomed drug products.
As allotment of the biologic approval process, the FDA considers the achievability of medication errors and name confusion, so that abeyant assurance issues associated with these factors can be minimized.
Approved Drugs Not Affected
Some hydrocodone pain-relief articles are FDA-approved. But a lot of hydrocodone formulations marketed to abolish coughs haven't been accustomed by the FDA.
"Companies business these crooked articles accept not approved the safety and ability of these drugs," the FDA's Steven Galson, MD, MPH, says in a account release.
"A case in point -- no hydrocodone ahem suppressant has been established as safe and able for accouchement beneath 6 years of age and some of these crooked articles backpack labels with dosing instructions for accouchement as young as 2 years of age," says Galson, who directs the FDA's Center for Drug Evaluation and Research.
Anyone business crooked hydrocodone articles that are currently labeled for use in accouchement adolescent than 6 years of age have to end added manufacturing and administration of the articles on or afore Oct. 31, 2007.
Those business any added crooked hydrocodone biologic articles have to stop manufacturing such articles on or afore Dec. 31, 2007, and have to cease further shipment in artery business on or afore March 31, 2008.
Failure to heed those deadlines may draw FDA enforcement.