FDA Lowers Boom On Unapproved Cold Medicines
March 3, 2011
Has the FDA approved that cold remedy? Maybe not.
They’re oldies but not goodies, the Food and Drug Administration says about more than 500 prescription cough, cold and allergy remedies it is ordering off the market.
The drugs, ranging from Accuhist to Zotex syrup, were never put through the paces of an agency review. So now the regulators say the unapproved drugs can’t be sold anymore.
I didn’t recognize a single brand name when I scrolled through the full list of affected medicines. And when I plugged the names of 10 or so into the search box at online medicine retailer drugstore.com none of them came up. Well, Zotex got auto-corrected to Kotex, but that doesn’t count.
How could it happen that these unapproved drugs are on the market? Turns out that medicines sold before 1962 didn’t have to be thoroughly reviewed by the agency. Even after new FDA requirements kicked in, the old meds were allowed to stay on pharmacy shelves, with the understanding that they’d get submitted for review someday.
For many drugs that didn’t happen. Now the FDA is lowering the boom.
Many of the drugs contain well-accepted ingredients, such as dextromethrophan for coughs and pseudoephedrine, a decongestant. But FDA says the combinations in some of the remedies could be a problem. Also the agency can’t be sure about the purity of the ingredients in the medicines that haven’t been subject to its review.