The FDA has issued its strongest warning a boxed warning to physicians advising against the use of codeine as a painkiller for children following surgery to remove either tonsils or adenoids a common procedure, estimated to occur about 500,000 times annually. The warning states that kids given codeine following these procedures could experience fatal breathing problems.
Health care professionals should prescribe an alternate analgesic for post-operative pain control in children who are undergoing tonsillectomy and/or adenoidectomy. Codeine should not be used for pain in children following these procedures, the FDA said in a statement.
The warning was issued after they found a total of 10 deaths and three overdoses in their database that tracked side effects from 1969 through 1 May 2012. Children ranged in age from 21 months to 9 years, and all were given codeine doses within normally prescribed ranges.
If you do the math, the chances of codeine causing death in children are at most 1 in 2 million and probably even less, since some of the 10 deaths may have occurred simply from the surgery, says Dr. Bloom. He adds, And the alternatives aren t perfect either. Tylenol is a modest analgesic at best, and can be quite toxic at doses barely higher than the maximum recommended dose. Advil can cause stomach bleeding. Nothing is 100% safe. Children probably have a greater risk of the ceiling falling on them during surgery than dying from codeine. Put this near the top of your list of things not to worry about.
ACSH s Dr. Elizabeth Whelan adds, There are times when children need the pain-relieving benefits of codeine, and they should be able to get it. I really don t understand the FDA s logic here. It is beyond hyperprecautionary.