FDA Codeine Alert Won't Hamper Practice Much

Many clinicians had scratched codeine off their lists for treating postoperative pain in children long before Wednesday's FDA warning, according to doctors contacted by MedPage Today and ABC News.
The drug "is a poor choice for post-op pain" and "is no longer considered the standard of care for pain management," said Laura Schanberg, MD, of the Duke Clinical Research Institute in Durham, N.C., in an email to both news organizations.
The FDA warned healthcare professionals Wednesday against prescribing codeine as a post-operative treatment for pain in pediatric patients who have undergone tonsillectomy or adenoidectomy after reports of three deaths and one near-fatal case of respiratory depression.
Clinicians consider the drug a poor choice largely because of patients' varied responses to the morphine metabolite, researchers said. Some metabolize it too quickly, while others get hardly any pain relief at all.
"Ultra-rapid metabolizers are at risk for high side effects and respiratory depression," Jeffrey Galinkin, MD, of the University of Colorado at Denver and chair of the American Academy of Pediatrics Committee on Drugs, said in an email.
On the other hand, he noted, "poor metabolizers, 5% to 10% of our general population, get no effect from the drug since it cannot be converted to its active component, morphine."
The agency recommended child patients should receive the lowest effective dose of codeine-containing drugs, for the shortest time, and on an as-needed basis.
Many clinicians said they use lower-risk alternatives in their pediatric patients instead.
"I would be more inclined to use other drugs with a more dependable pharmacology," Joseph Tobin, MD, of Wake Forest University in Winston-Salem, N.C., said in an email. "Codeine is really a pro-drug. It doesn't work in its natural form."
One common drug co-administered with codeine post-operation is acetaminophen, but "there is no known benefit of acetaminophen with codeine over acetaminophen alone for post-tonsillectomy pain in kids," wrote Alan Greene, MD, of Stanford University in Stanford, Calif.
"Acetaminophen with hydrocodone appears to be more effective and less risky than acetaminophen with codeine, especially if on a schedule, rather than waiting for pain to break through," he added.
However, risk of respiratory depression is common to any opioid analgesic, said Eugene Viscusi, MD, of Thomas Jefferson University in Philadelphia.
"It just happens that codeine is the more commonly prescribed agent in this setting," he explained, adding that the risk "is compounded by the fact that many of these patients have their surgery because they have existing airway obstruction, so these children are already at risk of airway obstruction and respiratory events."