A closer look at the FDA’s stronger warning on pain meds for kids

The latest Food and Drug Administration warnings on medications containing codeine and tramadol, two opium derived medicines, restricts use in children under 12-years-old and strictly cautions usage in 12 to 18 year-olds due to risks of slowed breathing and death.

But while this might seem to be related is the fact that legitimate opioid prescriptions often seem to be the gateway into addiction—they also have to do with two other problems with all medications that are often ignored:

1. Children are not just small adults medically.

2. Size does matter at least in medication.

The FDA believes that some children are faster metabolizers combined with their generally smaller weights than adults can cause a very high active ingredient to weight ratio and unexpected death.

In a recent blog, I discussed how just prescribing appropriate painkillers can start a course to addiction and that is still true, but this ban is about how hard it is to prescribe to children because of both size and metabolism differences in younger patients.

The serious concerns about codeine which has been used as a pain-killer, a cough suppressant, and sleep-inducer since the 1830s are a surprise for people over 50 years old since in the 1950s it did not even require a prescription. Also, the drug phenrgran with codeine was prescribed to children and adults for the common cold/cough routinely up to the 1980s. Codeine itself is not active medically, but the body quickly turns it into morphine and then it is another (and very strong) opioid.  

Codeine cough medicine has been known to cause addiction and overdose deaths in adults such as a rapper Pimp C in 2007, but since it such a strong cough-suppressant it had been given to small children after surgery when coughing might result in damage at the surgery site. Many more children given codeine died from apnea or not breathing after surgery than predicted. 

Children’s doctors are always very careful to prescribe by weight so that they do not overdose the children who come in many different weights. Unfortunately, the rate of the body turning the codeine into morphine varies very widely even when the prescriber is being careful with measuring. (I do not care for adults, but I have always been surprised that doctors do not vary doses much when adults can be 100 or 400 pounds).

Tramadol was invented in 1962, but was not approved in the US until about 20 years ago. About 30 million prescriptions were written in the US this year and the FDA noted that there were increased fatalities when it was used in children and issued these restrictions. The media have noted that tramadol is not approved in children, but very few medications are so the fact that it is being prescribed to kids is not illegal. However, it does seem to be dangerous.

Again, medical practitioners should be “therapeutic nihilists” who only use medication when absolutely beneficial and safe. Parents always want me to treat children’s minor illnesses with medicine and I refuse. I also do not believe we have to eradicate all pain, we just have to make children more comfortable. So I avoid opiates as much as possible and reserve them for the worse pain such as sickle cell disease, cancer and multiple trauma, and even than I try milder painkillers first. I understand parents want to soothe their children—we just need to remember that medication isn’t always the answer.