Also Friday, FDA officials announced a crackdown on drug companies that make unapproved prescription drugs containing the narcotic hydrocodone, which is used as a cough suppressant and pain killer.
Hydrocodone is one of the strongest drugs used to treat pain or to suppress cough. It's also widely abused and, if improperly used, can lead to illness and death. Overdoses of hydrocodone can cause breathing problems or cardiac arrest and can impair motor skills and judgment, U.S. Food and Drug Administration officials said.
"The FDA is announcing an action to stop the illegal marketing of any unapproved drug product containing hydrocodone," Deborah M. Autor, director of the agency's Office of Compliance, Center for Drug Evaluation and Research, said during a Friday teleconference.
Some pain-relief products containing hydrocodone, such as Vicodin, are FDA-approved. But most of the drugs with hydrocodone now marketed to suppress coughs have not been approved, officials said.
Autor said the unapproved products are made by some 100 manufacturers.
The FDA said it was particularly concerned about improper pediatric labeling of unapproved hydrocodone cough suppressants -- also known as antitussives. None of the drugs that contain hydrocodone has been approved for children younger than 2 years old.
"There are hydrocodone-containing products on the market that claim they are suitable for children as young as 2," Autor said.
Also, many of the products don't carry the proper warning label and often have similar names to other medications, creating a high risk of medication error, Autor added.
"Product names are so similar that the wrong doses or wrong medication may be dispensed," she said.
Hydrocodone is a narcotic regulated by the U.S. Drug Enforcement Administration, Autor said.
Friday's announcement came one day after President
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