Tylenol/Acetaminophen was approved as a pain medication in the United States in 1950, long before the current regulatory environment, and the drug was allowed to go over-the-counter in 1959. According to testimony at an FDA Advisory Committee hearing, the first cases of fatal overdose of acetaminophen were reported in approximately 1966.
An FDA Advisory Committee was convened in 1977 to discuss, at least in part, acetaminophen. Incredibly, the Advisory Committee in 1977 recommended that a warning specifically concerning the risk of liver failure be placed on the label of Tylenol bottles. The recommended warning essentially said "do not exceed recommended dosage because severe liver damage may occur." As you know if you are reading this, such a liver warning was not placed on the label of Tylenol for more than 30 years.
In fact, last year an Advisory Committee to the FDA voted that the single adult acetaminophen dose should be reduced from 1,000 mg (two extra-strength Tylenol) to 650mg. This FDA advisory committee is made up of over 30 doctors and other experts in the area. In addition, the advisory committee expressed concern because many people may unknowingly take multiple combinations of drugs that each contains acetaminophen when they are sick.
The bottom line is that a committee of expert doctors recognized 30+ years ago that severe liver damage could occur with ingestion of Tylenol -- but no such information was ever brought to the consuming public.
Medical Literature on Tylenol Goes Way Back
The medical literature began reporting on the relationship between Tylenol/acetaminophen and liver failure years ago and there is no doubt that there is a cause-and-effect relationship between Tylenol and the onset of liver failure.
Tylenol was initially marketed and sold as a 325 mg tablet. In other words, if an adult took 2 tablets, he or she would be ingesting 650 mg of acetaminophen per dose. In 1975, an extra-strength version of Tylenol was approved by the FDA. This is what is almost exclusively on the market today. Extra Strength Tylenol contains 500 mg of acetaminophen per tablet. Thus, when an individual takes two tablets as instructed, he or she is ingesting 1000 mg or 1 gram of acetaminophen per dose. The maximum daily dose is 4 g or 8 Extra Strength Tylenol. The label for Extra Strength, however, states that the individual should take “two Extra Strength Tylenol every four to six hours, but should not exceed eight tablets in a 24-hour period.” This is confusing in and of itself because, if an individual is sick, and is taking Tylenol every four hours as instructed, they will reach the maximum daily dose in16 hours, which is a set-up for an overdose and potential liver injury.
Interestingly, research indicates that the vast majority of people receive pain relief with just the 325 mg Regular Strength Tylenol. If this is in fact the case, and if McNeil (the manufacturer of Tylenol) is aware of the relationship between increased doses of acetaminophen and liver failure, then why introduce the Extra Strength Tylenol in the first place?
Moreover, a 650 mg Tylenol product was approved in 1994. Again, why would a company want a consumer to ingest so much acetaminophen when it knows that there is a relationship between the drug and liver injuries and liver failure? It makes no sense other than for profit.
In sum, the industry has been well aware since the mid 1970’s that Tylenol and acetaminophen are related to liver injury, liver failure and death on a substantial scale both in the United States and throughout the world. Nevertheless, the industry has refused to be candid with the consuming public about the true risks associated with this drug, instead always marketing Tylenol as a drug that is as “safe as candy.”
