FDA slams illegal cough drugs containing hydrocodone

1 October, 2007

Health officials of the United States are cracking down 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 is 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, according to the United States Food and Drug Administration (FDA).

Hydrocodone is a narcotic regulated by the United States Drug Enforcement Administration.

The FDA is announcing an action to stop the illegal marketing of any unapproved drug product containing hydrocodone, Deborah M Autor, director of the FDA’s Office of Compliance, Center for Drug Evaluation and Research, said.

Some pain-relief products containing hydrocodone, such as Vicodin, are approved by the FDA, but most of the drugs with hydrocodone now marketed to suppress coughs have not been approved.

The unapproved products, Deborah M Autor said, 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.

According to Deborah M Autor, there are hydrocodone-containing products on the market that claim they are suitable for children as young as 2 years.
Also, many of the products do not carry the proper warning label and often have names similar to other medications, creating a high risk of medication
error. “Product names are so similar that the wrong doses or wrong medication may be dispensed,” she said.

The FDA’s announcement on September 28, 2007, comes one day after US 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.

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.

Meanwhile, the FDA’s ability to oversee clinical trials was called into question with the release of a highly critical report by Daniel R Levinson, inspector -General of the US Department of Health and Human Services, on September 28, 2007.

In the report, Levinson said he found that the FDA officials did not know how many clinical trials were being conducted. The FDA officials audited less than 1% of clinical testing sites.

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% 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 report by Levinson echoes other recent criticisms of the FDA’s oversight of imported food, foreign drug manufacturers, animal food, and medication safety.