Unapproved medicines ordered off the market
Washington ? Manufacturers of cold, cough and allergy medicines that contain the antihistamine carbinoxamine and have not been approved have been given 30 to 90 days to stop making the products.
In ordering this, the Food and Drug Administration said Thursday the estimated 120 such medicines that contain the antihistamine being sold today pose a safety risk to infants and young children.
Since 1983, the FDA has received reports of 21 deaths of children 2 and younger associated with the products, including those that contain carbinoxamine tannate and maleate.
It isn’t clear the drug was to blame, however.
The estimated 26 manufacturers of the drugs that have not been approved must seek FDA permission if they want to continue selling the medicines.
There are only two FDA-approved medicines that contain carbinoxamine, both made by Mikart Inc. of Atlanta.






