Unsafe Dosages of Tylenol

The evidence associating severe liver injury to Tylenol and other products containing acetaminophen, one of the most widely used pain-killers in the United States, is well documented. According to Sandra Kweder, M.D., deputy director of the Food and Drug Administration (FDA) Office of New Drugs, “Overdoses from prescription products containing acetaminophen account for nearly half of all cases of acetaminophen-related liver failure in the U.S., many of which result in liver failure or death.”

According to the FDA, most cases of acetaminophen-related liver failure occur in those who:

• took more than their prescribed dose in a 24 hour period
• took more than one acetaminophen-containing product at a time
• drank alcohol while taking acetaminophen

As a result of the growing recognition of the connection between liver damage and acetaminophen, the FDA is ordering changes in product labeling and prescription policies, and issued a consumer warning in January of 2011.

It is ordering that all prescription products containing acetaminophen be limited to 325 milligrams. This includes such products as Tylenol with codeine, Percocet, and Vicodin. These products may often not fully spell out the whole word or use an abbreviation in the list of ingredients. Common abbreviations for acetaminophen include APAP, AC, Acetaminophn, Acetaminoph, Acetaminop, Acetamin, and Acetam. The new prescription regulations will be phased in over a period of three years.

The FDA is also requiring a Boxed Warning for all prescription acetaminophen products, pointing out the risks of liver damage associated with the product. Boxed Warnings are the highest level the FDA assigns for calling attention to potentially serious or life threatening side effects. In addition, the FDA is requiring labeling pointing out potential allergic reactions, including swelling of mouth and throat, breathing difficulties, itching and rash.

Tylenol and other over-the-counter (OTC) medications containing acetaminophen are already required to carry appropriate warning labels informing consumers of possible side effects, including liver damage. The FDA warning is largely focused on the dangers of combining different products containing acetaminophen, especially the mix of OTC products such as Tylenol with prescription medications, and emphasizes that liver damage usually occurs only if a patient takes more than 4,000 milligrams of acetaminophen in a 24-hour period.