The FDA Imposes Black Box Warning on Tylenol
Americans purchase eight billion Tylenol tablets or capsules every year, as an aspirin alternative to relieve pain and reduce fever. Tylenol, a pharmacy staple since the 1950s under its generic name acetaminophen, is present in over 200 prescription or over-the-counter(OTC) pain relievers. In January 2011, the U.S. Food and Drug Administration (FDA) announced Tylenol is far more dangerous than decades of trusting consumers ever knew.
The FDA Black Box Warning
The Deputy Director of the FDA's Office of New Drugs made public that Tylenol is responsible for almost half of all acetaminophen-related liver failure in the United States, more than three times the liver failure rate attributed to all other drugs combined. Tylenol-caused liver toxicity can result in permanent liver damage, leading to liver transplants or death. The drug was not recalled; however, the FDA issued its strictest and most severe Black Box warning, a caution to the public that, even as it remains legally available, Tylenol is life-threatening.
The FDA concluded that Tylenol's connection to destructive and fatal liver damage is caused by overdose. Along with the directive to relabel Tylenol to warn consumers, the FDA instructed manufacturers to re-issue prescription Tylenol in its lowest effective dosage of 325 milligrams. There are currently single doses as high as 750 milligrams on the market, available in both prescription and OTC form. Among the widely-used prescription combination medications containing Tylenol are Tylox, Vicodin, Lortab and Percocet. Tylenol shows up in its highest single-dose concentrations in some OTC cough and cold remedies like NyQuil, Vicks and Coricidin, among dozens of others.
Tylenol Use and Misuse
Some accidental overdoses occur when unsuspecting patients take multiple prescription pain medications, each containing normal Tylenol amounts, but collectively adding up to a lethal daily dose. Further confusion happens when drug labels do not clearly identify Tylenol content. Label aliases are often substituted, including abbreviations and similar sounding names like APAP, AC, Acetaminoph, Acetaminop, Acetamin, or Acetam.
Although the FDA insists that Tylenol, used in recommended prescription doses, does not pose a consumer health threat, at least one study showed that regularly-prescribed doses of Tylenol can elevate liver enzymes to produce moderate liver problems. Normal doses of Tylenol, in combination with even small amounts of alcohol, have been shown to cause irreversible liver failure.
The Public as Watchdog
The new FDA Tylenol warning and dosage limitations apply only to prescription combination Tylenol. They do not affect drugs containing Tylenol that are more easily used and abused--those already mainstream marketed over-the-counter. Drug makers have been given a full three years to comply with the FDA ruling. In the meantime, reports continue to increase for Tylenol-related liver damage and death, placing the burden of personal safety on the public.
