Codeine Still Prescribed to Kids Despite Strict FDA Warning

A new multi-university study finds that up to one in 20 children were still being prescribed codeine to treat pain after tonsil and adenoid surgery, despite a “black box warning” being issued by the Food and Drug Administration (FDA) two years prior stating that opioid use after routine pediatric surgeries can be fatal.

A black box warning is the FDA’s strictest warning regarding prescription drugs or drug products. In 2013, the FDA issued this warning against the use of codeine following tonsillectomies and adenoidectomies in children, due to an increasing number of reported deaths in such instances.

The study, conducted by researchers at the University of Chicago Medicine, the University of Michigan and Harvard University is published in the journal Pediatrics.

“We should not prescribe codeine to children, for any reason,” said Kao-Ping Chua, M.D., Ph.D., lead author of the new study and assistant professor of pediatrics and communicable diseases at the University of Michigan.

“Some children rapidly convert codeine to morphine, resulting in a risk of overdose. Other children poorly metabolize codeine to morphine, resulting in no improvement in pain. Therefore, codeine is not just potentially unsafe, but also potentially ineffective.”

According to Chua, who worked at University of Chicago Medicine while conducting the research, codeine has traditionally been one of the most common drugs used to treat pain in children after surgery.

“What was unclear, however,” he said, “is whether the 2013 FDA black box warning — the strongest warning the FDA can issue — was successful in completely eliminating the use of codeine in this situation.”

For the study, Chua and co-authors Mark Shrime, M.D., MPH, Ph.D., of Harvard University, and Rena Conti, Ph.D., of University of Chicago Medicine, analyzed data of more than 300,000 privately-insured children who had the surgeries between 2010 to 2015. The five-year study period allowed researchers to look at at prescribing patterns before and after the FDA warning.

Their findings did show a decrease in codeine prescriptions from the 2013 black box warning. Still, the practice continued: one in 20 children undergoing these surgeries were prescribed codeine in December 2015, regardless of its well-documented safety and efficacy issues.

“The residual inappropriate codeine prescribing is consistent with other research showing that FDA black box warnings can make substantial, but incomplete, impact on clinical practice,” said Conti, who studies the effect of FDA warnings.

The researchers assert that there are safer and more effective alternatives to helping children manage pain after having their tonsils or adenoids removed. Many patients rely on over-the-counter painkillers like acetaminophen (Tylenol), which has been proven to be an effective post-surgical analgesic. Ibuprofen, despite some early concerns, has also been shown to be effective and doesn’t appear to increase the risk of post-tonsillectomy bleeding.

In severe cases, alternative opioids like oxycodone and hydrocodone may be effective. However, these drugs also have side effects and are prone to abuse, says Chua, so the best option is to start with over-the-counter painkillers and rely on opioids only when absolutely necessary.

In the future, the researchers believe that efforts should focus on eliminating all inappropriate codeine prescribing and encouraging the use of effective non-opioid medications such as acetaminophen and ibuprofen.

Source: University of Chicago Medical Center