FDA Cracks Down on Unapproved Cough Medicines
FRIDAY Sept. 28, 2007 -- U.S. health officials announced Friday 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 said. "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 comes one day after President George W. Bush signed a five-year renewal of a law that helps fund the FDA's ability to oversee prescription drug safety.
The new law allows the FDA to collect higher fees from drug and medical device makers, which helps defray the agency's costs of reviewing products submitted for approval. The law also gives the agency more powers to take action when there are problems with drugs already on the market. For example, the FDA can order drug companies to do further studies on the safety of medicine and to put new label warnings on products. The agency now has the authority to fine companies that fail to comply with such orders.
Under the new Food and Drug Administration Amendments Act of 2007, drug and medical device companies must also publicly release results of all clinical trials that show how well approved drugs performed, according to published reports.
But the FDA's ability to oversee clinical trials was called into question Friday with the release of a highly critical report by the inspector general of the U.S. Department of Health and Human Services.
In the report, Daniel R. Levinson said he found that FDA officials didn't know how many clinical trials were being conducted and audited fewer than 1 percent of clinical testing sites. In the few instances where FDA inspectors did check a site, they generally showed up long after the tests had been completed, Levinson noted, The New York Times reported.
The FDA has 200 inspectors to monitor about 350,000 testing sites. Even when inspectors identified serious problems in human clinical trials, top FDA officials downgraded the inspectors' findings 68 percent of the time, Levinson found. In the rest of the cases, it was rare for the FDA to follow up with inspections to assess whether corrective actions ordered by the agency had been done, the Times reported.
The Levinson report echoes other recent criticisms of the FDA's oversight of imported food, foreign drug manufacturers, animal food and medication safety.
In announcing Friday's decision on hydrocodone, the FDA said it was prompted to take the action, because it had received reports of "medication errors associated with unapproved hydrocodone products and reports of confusion over the similarity of the names of unapproved products to approved drug products."
Autor said that about 2 percent of all prescriptions written in the United States are for unapproved drugs. With some 200 unapproved drugs containing hydrocodone on the market, it's highly likely that most of the prescriptions for cough medicines that contain hydrocodone are for unapproved brands, she said.
Currently, the approved cough medications containing hydrocodone are: TussiCaps; Tussionex Pennkinetic; Hydrocodone Compound; Mycodone Homatropine Methylbromide; Hycodan; Tussigon; and Vicodin, she said.
According to the FDA, companies marketing unapproved hydrocodone products that are labeled for use in children younger than 6 years of age must stop manufacturing and distributing the products by Oct. 31.
Companies making other unapproved hydrocodone drug products must stop manufacturing such products on or before Dec. 31, 2007, and must "cease further shipment in interstate commerce on or before March 31, 2008."
The FDA said there are alternatives to unapproved hydrocodone-containing products. These include one of the seven approved cough medicines that contain hydrocodone as well as other cough suppressants that don't use hydrocodone.
For more on drugs containing hydrocodone, visit the U.S. Food and Drug Administration.
Posted: September 2007
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