WASHINGTON, March 3 (UPI) -- The U.S. Food and Drug Administration says the makers of about 500 unapproved prescription cough and cold medicines must take them off the market.
While the drugs have been linked to only a few relatively minor problems such as drowsiness and irritability, the FDA is concerned that medical problems associated with them may be significantly underreported, the Los Angeles Times reported Wednesday.
"We have some specific safety concerns with some of them," Deb Autor, head of compliance in the FDA's drug office, said.
Some of the drugs in question are labeled as suitable for infants and children but contain ingredients a 2008 FDA advisory warned should not be given to children under age 2.
Others are billed as timed-release products, but if quality controls are inadequate, some may release drugs too slowly, too quickly or not at all, Autor said.
Many of the targeted drugs came on the market before a 1962 law that required makers to prove their effectiveness.
None of the drugs are well-known brands, although Autor listed Cardec, Lodrane 24D, Organidin and Pediahist as brands consumers may have encountered, the Times reported.