FDA Warnings

Tylenol, also known as acetaminophen, has sold billions of tablets and capsules since being introduced in the 1950s as a pain reliever and fever reducer. Americans have grown to rely on Tylenol as a safe product to take both over-the-counter and in prescription medications. However, the Food and Drug Administration has recently issued a Black Box Warning for the prescription strength Tylenol products.

Black Box Warning

Also known as “black label warning” or “boxed warning”, the Black Box Warning is placed on prescription medication to warn consumers of serious side effects or risks which may be life-threatening. It is the FDA’s strongest warning label placed upon prescription medication.

In the case of Tylenol, the Black Box Warning warns consumers of liver damage and failure which can result from taking too much acetaminophen. Liver damage can occur to a patient when more than 4,000 milligrams of acetaminophen is taken in one day. The FDA has reported that close to half of all acetaminophen-related liver failure cases in the United States are connected to Tylenol. The liver failure rate of Tylenol products is also three-times greater than all other combined medications.

The misuse of Tylenol can cause permanent liver damage, resulting in the need for a liver transplant, or even possibly death. It is important to keep in mind that this Black Box warning is for prescription strength Tylenol only and does not apply to over-the-counter Tylenol tablets or capsules.

When Using Tylenol

When taken in prescribed amounts, Tylenol does not contribute to liver problems. The FDA has taken a further step in protecting patients by setting a limit on the amount of acetaminophen per pill to 325 milligrams. This is a drastic decrease from as much as 750 milligrams of acetaminophen per pill in previous forms of Tylenol.

However, the misuse of taking more than the prescribed dosage can cause serious liver problems. Examples of prescription pain medications which contain Tylenol are Percocet, Vicodin, Roxicet, Fioricet and Lortab. Some patients may inadvertently take an overdose of Tylenol by taking multiple prescription pain relievers and being unaware that they all contain Tylenol. This Black Box Warning can prevent such tragedies from occurring by notifying the patient directly on the prescription that a medication contains Tylenol, especially when there has been confusion surrounding the usage of abbreviations such as APAP, Acetaminop, Acetamin, AC or Acetam instead of clearly stating acetaminophen.