FDA warns some cough medicine unapproved

WASHINGTON — Federal regulators are attempting to crack down on the sale of unapproved and potentially deadly prescription drugs, warning manufacturers Thursday to stop selling cough drops and syrups containing a common antihistamine if they haven't received government permission.

Food and Drug Administration (FDA) officials expressed special alarm that the ingredient carbinoxamine, approved only to fight allergy symptoms, is being sold to treat children younger than 2, even though its use for coughs and colds has never been tested.

The agency has received 21 reports of deaths since 1983 among children younger than 2 who took medicines containing the ingredient, though regulators are not certain carbinoxamine was the cause.

"Right now, many unapproved drugs represent a public-health threat, because consumers wrongly assume that these widely marketed and available drugs are approved and have been found to be safe and effective by the FDA," said acting FDA Commissioner Andrew von Eschenbach.

Agency officials gave makers of the unapproved antihistamine 90 days to apply for FDA approval or warned they would take drugs off the market. The agency said about 120 unapproved cough and cold products containing carbinoxamine are being sold.

Just two products containing carbinoxamine have received FDA approval, both made by Mikart of Atlanta.

FDA officials said the unapproved carbinoxamine medicines include Histex, Andehist and Cardec.

Makers of these and other unapproved drugs often advertise their products, and many are listed in the Physicians' Desk Reference, which doctors use as a guide in prescribing drugs.

In documents made public yesterday, the FDA said the labels of unapproved drugs often do not mention they were never reviewed by the agency.

The sale of unapproved products has been a persistent problem for the FDA, which estimates there are hundreds of ingredients in thousands of products being marketed without government permission.

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 received FDA approval because they were sold before a 1962 federal law required agency certification that the product is safe and works before it can be sold.

In other cases, companies never applied to the agency for permission. Doctors and pharmacists may not know the drugs aren't approved, FDA officials said.

Material from The Washington Post and The Associated Press is included in this report.