FDA to target unapproved, oft-abused pain drugs
(Adds background, approved versions, FDA comments)
By Kim Dixon
WASHINGTON, Sept 28 (Reuters) - U.S. regulators said on Friday they were cracking down on companies selling unapproved versions of an often-abused painkiller with the potent narcotic hydrocodone.
The U.S. Food and Drug Administration said the ingredient, legal in approved drugs like Vicodin, is now widely used and abused in unapproved prescription products to stem coughing.
Roughly 200 products on the market contain an unapproved version of hydrocodone, with just seven approved products including those made by a unit of Tyco (TYC.N) and King Pharmaceuticals KG.N. Hydrocodone has been available since the 1940s and regulations have changed many times in the intervening decades.
The effort is part of a larger FDA strategy to crack down on drugs that slip through the approval process, announced last year. The agency estimates about 2 percent of prescriptions written have not been through its clearance process.
The FDA has received reports of overdoses and deaths related to misuse of the drug.
Of particular concern are products marketed toward children under six years old because the drug has not been proved to be safe in that group.
"It's important to remember that kids are not just little adults," Deborah Autor, director of the FDA office of drug compliance, told reporters.
The FDA said it will take enforcement action against companies marketing unapproved versions, but did not name specific ones. Companies selling the drug for children under the age of six must stop before Oct. 31, the agency said.
There are seven FDA-approved versions of cough suppressants containing the drug. They were listed at: here#hydrocodone
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