WASHINGTON -- Federal regulators are attempting to crack down on the sale of unapproved and potentially deadly prescription drugs, warning manufacturers yesterday to stop selling cough drops and syrups containing a common antihistamine if they haven't received government permission.
Food and Drug Administration officials expressed special alarm that the ingredient carbinoxamine, approved only to fight allergy symptoms, is being sold to treat children under the age of 2, even though its use for coughs and colds has never been tested.
The agency has 21 reports of deaths among children under 2 who took medicines containing the ingredient, though regulators are not certain carbinoxamine was the cause.
Agency officials warned that they would go so far as to take drugs off the market if companies continue selling about 120 unapproved cough and cold products containing carbinoxamine after 90 days. The only products containing carbinoxamine that have received FDA approval are manufactured by Mikart, Inc., of Atlanta, and are sold as Palgic Carbinoxamine Maleate Oral Solution, Carbinox Maleate Solution and Palgic Carbinoxamine Maleate Tablets.
The sale of unapproved products has been a persistent problem for the FDA, which estimates there are hundreds of ingredients in thousands of products that are being marketed without government permission.
Overall, the agency estimates that less than 2 percent of prescribed drugs have not been approved.
Officials said the move against carbinoxamine manufacturers signaled a more aggressive stance against all companies selling unapproved products, which besides some cough and cold products include some sedatives and single-ingredient narcotics.
Some drugs never got FDA approval because they were sold before a 1962 federal law required agency certification that the product is safe and works in order to be sold. In other cases, companies never applied to the agency for approval.
Doctors and pharmacists might not know the drugs aren't approved, FDA officials said.