Acetaminophen is found in Tylenol, but is
also in almost 200 different products, including cold and flu remedies. Taken by
about 100 million Americans a year, acetaminophen is the most widely used
nonprescription drug in the US.
The FDA's Nonprescription Drugs Advisory Committee expressed almost unanimous
support for an immediate change to the drug's labeling, citing concerns about
consumers who use the product inappropriately.
The FDA convened Thursday's advisory panel as part of an ongoing review of
over-the-counter drugs that began in 1988. On Friday, the panel will consider
whether warnings on other popular nonprescription pain relievers, including
ibuprofen, provide adequate information about possible gastrointestinal side
effects.
US regulators have discussed and debated acetaminophen's possible liver
toxicity since 1977. The purpose of Thursday's meeting was to revisit the issue
in light of recent data suggesting that additional measures might be needed to
prevent unintentional overdoses.
Overdoses are the most often cited cause of acetaminophen-associated liver
toxicity. According to federal figures, acetaminophen overdoses lead to about
56,000 emergency room visits, 26,000 hospitalizations and 450 deaths a year.
Although the majority of the events are suicide-related, FDA officials said
during Thursday's meeting that about 13,000 of the emergency room visits, 2,200
of the hospitalizations and 100 of the deaths are apparently unintentional.
Causes include inadvertent use of multiple acetaminophen-containing products
at the same time and the misinformed belief that larger doses will lead to
faster relief, the FDA officials said.
Advisory panel members recommended adoption of a label that more clearly
outlines the possible effects of an overdose and points out the presence of
acetaminophen in products such as cough and cold medications.
"We don't want to make Tylenol look like a dangerous drug," said panel member
Dr. Nathaniel Katz, an anesthesiologist in New Rochelle, New York. "Still, it
seems to me that someone buying something in the supermarket should know what's
in it."
The FDA is not required to follow its advisors' recommendations, but it often
does so.
If the agency does require stronger labels, it will have the support of some
industry members.
McNeil Consumer, the Johnson & Johnson subsidiary that makes Tylenol,
already has proposed the adoption of a label cautioning that inappropriate use
could lead to liver toxicity.
McNeil Vice President Dr. Anthony R. Temple told Reuters Health the firm has
been encouraging other manufacturers to adopt the new label on a voluntary
basis. "It would certainly help if the FDA finalized a rule," he said.
But both McNeil and the FDA stressed that unintentional overdoses and liver
toxicity are rare events given the number of users of acetaminophen.
"The agency continues to believe that acetaminophen is a safe and effective
OTC analgesic that benefits tens of millions of consumers every year," the FDA
said.
