Why Acetaminophen was Never Proven Safe

The FDA has a long history, dating back to the 1906 Pure Food and Drug Act… but the agency never had the power to effectively regulate new drugs until the thalidomide disaster of the late 1950s. Thousands of pregnant women in the US were exposed to a drug that caused fetal death and deformity. As a result, in the 1960s, the FDA got some teeth and began controlling which drugs got onto the market.

But acetaminophen had already been on the market, and no concerns had been raised. It was effectively grandfathered past the FDA.

Then, making the mistake of assuming that babies would react to acetaminophen the same as adults, medical researchers in the 1970s decided that acetaminophen was safe for babies because it did not destroy livers in babies.

Then, in the early 1980s, aspirin use in children was connected with a very dangerous condition called Reye’s syndrome, and modern medicine made the switch from aspirin to acetaminophen.   

Finally, in the 1990s, effective direct-to-consumer advertising affected our beliefs about drugs, and eventually resulted in almost all babies and children being exposed to acetaminophen.

It wasn’t until 2008 that a scientist actually asked the question: Is acetaminophen, which is known to profoundly affect brain function, actually safe for a baby’s brain? Does it cause any long-term problems?

The answer of that 2008 study was a resounding “NO, acetaminophen is associated with long term problems, particularly regressive autism.”

But the belief that acetaminophen was safe persisted in the medical literature. The 2008 study was largely ignored, as were numerous other studies confirming the dangers of acetaminophen that were published starting in 2013.

In 2021, we asked the question: Is the medical literature correct? Can the literally hundreds of papers in the medical literature claiming that acetaminophen is safe be correct?

We found that the answer is, again, NO. Acetaminophen was never proven safe for a baby’s brain. It was proven safe for a baby’s liver, but not for their brain.

Dozens of studies that ask the question, is acetaminophen safe for a baby’s brain, have been conducted, and all show that the answer is NO. The only reason that we thought it was safe in the past was because nobody asked the question.

Modern science often works by probing a specific idea, called a hypothesis by scientists. If nobody suggests that acetaminophen might cause autism, and scientists never try to test the hypothesis, then we might just remain ignorant.

And if somebody does finally test the hypothesis, and they find it to be correct, but it doesn’t agree with how everybody else thinks, then it can take decades before the new information becomes widely accepted.

That is how science has worked for over a century now. As the legendary scientist Max Planck stated “A new scientific truth does not triumph by convincing its opponents and making them see the light, but rather because its opponents eventually die.”

It is tragic that so many people are being hurt as we wait.