Awhile back the FDA cracked down on OTC cold medicines that were potentially harmful to children under 2. As part of that effort, the agency has now “ordered the removal from the market of more than 500 prescription drugs used to treat colds, coughs and allergies because the medications had never gone through a federal review of their safety and effectiveness,” says the NYT Prescriptions Blog.
“We don’t know what’s in them, whether they work properly or how they are made,” Deborah Autor, the director of the office of compliance in the F.D.A.’s drug division, said in a telephone news conference on Wednesday morning.
That’s comforting, right?
Apparently, there are drugs that have been marketed since before the 1962 law that requires drugs to go through FDA review. The NYT is reporting that the FDA says that many doctors are unaware that the medicines they are prescribing were never approved by the FDA.
The FDA says the the manufacturers of this group of unapproved drugs have 90 days to stop manufacturing them and 180 days to stop distribution.
You can find a list of the drugs here.
F.D.A. Orders Prescription Cold Drugs Pulled From Market [NYT Prescriptions Blog]