WASHINGTON - The Food and Drug Administration on Wednesday ordered the makers of about 500 unapproved prescription cough and cold medicines to get them off the market because they have not been proved safe and effective.
The drugs have been linked to only a few relatively minor problems, such as drowsiness and irritability, but the FDA is concerned that other problems with them may be significantly underreported.
"We have some specific safety concerns with some of them," Deb Autor, head of compliance in FDA's drug office, said in a telephone news conference.
Some of the targeted drugs are labeled as suitable for infants and children but contain ingredients covered by a 2008 FDA advisory that warned against using over-the-counter medications in children under age 2.
Others the FDA ordered removed from the market are billed as time-release products. Such medications are difficult to manufacture, and if quality controls are inadequate, some may release drugs too slowly, too quickly or not at all, Autor said.
People are also reading…
The FDA also moved against several unapproved products that contain possibly dangerous combinations of drugs, such as two anti-histamines, which can cause over-sedation.
None of the drugs is a household name, though Autor listed Cardec, Lodrane 24D, Organidin and Pediahist as brands consumers may have encountered.
In addition, none of the drugs fills a unique niche. "There are multiple other (approved) products available," Autor said.
It's not clear how much of a public health threat the drugs pose.
Wednesday's announcement does not affect over-the-counter preparations, which are widely used to treat cough and cold symptoms.
A pharmacist who reviewed the FDA's list of unapproved cough and cold drugs said many of them already are off the market.
