FDA Experts Urge Ban on Cold Medicines for Young Children

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 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 law, the 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, theTimesreported.

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, theTimesreported.