Pediatric patients who have undergone either procedure should receive only the lowest effective dose of drugs that contain codeine, for the shortest time, and only on an as-needed basis, the agency said.
The warning was issued after the FDA received reports of three deaths and one near-fatal case of respiratory depression in pediatric patients, ages 2 to 5, who had their tonsils and/or adenoids removed to treat sleep apnea syndrome.
Caregivers should be aware of the potential signs of overdose, including unusual sleepiness, difficulty being awakened, confusion, and noisy or labored breathing. If symptoms arise, caregivers should cease drug treatment and consult a healthcare professional immediately, the FDA said in a statement.
The agency noted that codeine is converted into morphine in the liver and that some patients metabolize codeine faster, which can result in higher concentrations of the drug in the blood, and can lead to overdose and death.
The agency noted that the patients who died exhibited evidence of the faster metabolism.
The FDA added that the condition occurs in approximately one to seven patients out of every 100, but certain ethnic groups are at a higher risk for ultra-rapid metabolism. The condition can only be identified through a genetic test.
The agency is reviewing adverse event reports and other data "to determine if there are additional cases of inadvertent overdose or death in children taking codeine and if these adverse events occur during treatment of other kinds of pain, such as postoperative pain following other types of surgery or procedures," Bob Rappaport, MD, director of the FDA's Division of Anesthesia, Analgesia and Addiction Products, said in a statement.
Source: Cole Petrochko, Associate Staff Writer, MedPage Today Published: August 15, 2012