The FDA advisory committee discussed proposals to make acetaminophen, found in Tylenol, safer in response to links between the drug and liver failure. The committee suggested lowering adult dosages from 1,000 mg to 650 mg, restricting 1,000 mg dosages to prescription only, and eliminating prescription combination drugs containing acetaminophen. Experts think some changes could help but warn that removing drugs entirely could impact pain treatment, and consumers may unintentionally exceed dosages by taking multiple acetaminophen products. The FDA will review options and make decisions in the next 3-6 months.

1. Acetaminophen
Drug found in Tylenol causing a stir
By HANNAH POTURALSKI • hpoturalski@limanews.com • 419-993-2091
L
IMA — When you see “If we decide to change either intentionally, often
the all-too-familiar dosage, it will take at least a because they think it will
white pill splashed red year and then we have to work better, which is not the
with the “Tylenol” printed study whether the lower case, or unintentionally,
on its side, do you fear the dosage is effective,” Riley said. often because they don’t real-
possibility of dying if you Shields said she’d be con- ize that several products they
take it? cerned if medications like are taking at the same time
Well, that’s what’s on the Vicodin and Percocet were (both prescription and over-
mind of the 37-member advi- removed. the-counter) contain aceta-
sory committee for the “You can’t pull it off the minophen,” according to
Federal Drug Administration market without thinking Tylenol’s Web site.
measuring the effects of about a replacement and This is not the first time
acetaminophen, the pain more options for pain relief,” the FDA has been presented
reliever found in Tylenol. Shields said. “Vicodin is the with ideas like these. Shields
On June 29 and 30, the top-selling pain management said the advisory board’s pro-
FDA held a public advisory medicine in the U.S.” posal to the FDA in 2002 was
committee meeting to dis- Shields also worries about similar.
AT A GLANCE cuss the links between aceta- the proposal to make 1,000 “Those recommendations
For details about the proposed minophen and liver failure milligram dosages of Tylenol didn’t go through, and so I
changes, visit www.fda.gov. and ask for suggestions to only available through pre- think the FDA will act on
make the drug safer. scription. some of the recent proposals
Symptoms that may The advisory board sug- “I don’t know if that will — but not all,” Shields said.
indicate liver disease: gested a slew of changes to accomplish much,” Shields Since the late 1990s the
the FDA, and nine different said. “People can just take FDA has been creating new
• Severe nausea
proposed ideas were voted two of the 500 milligram ways to educate aceta-
• Yellowing eyes or skin
on. pills.” minophen users on its effects
• Dark urine Shields said the concerns and not exceeding the recom-
Proposed ideas varied from
• Stomach pain lowering the maximum daily surrounding acetaminophen mended amount.
• Extreme fatigue dosage, lowering the adult come when someone con- Riley said the proposal will
dosage from 1,000 mil- sumes high doses. The cur- be reviewed and numerous
The FDA’s proposed ideas: ligrams to 650 milligrams, rent maximum dosage is 4 options discussed. The next
• Lower the maximum daily dosage having only one strength of grams a day, which equals steps will be decided in three
• Lower the adult dosage to 650 Liquid Tylenol available, and eight pills. to six months.
milligrams eliminating the prescription “Too much acetaminophen “The implementation
acetaminophen combination occurs when people use three process takes a lot longer,”
• Make the 1,000 milligram dosage products (such as Vicodin to four different products Riley said.
available only through prescription and Percocet). that have Tylenol as a com- Consumers may submit
• Set a limit on package sizes of All but one of the proposed ponent, such as NyQuil,” their opinions on the FDA
nonprescription acetaminophen ideas received more than 50 Shields said. Web site about this subject.
products percent of votes in favor, with Shields said its important About 20 comments have
• Eliminate acetaminophen combi- two gaining 97 percent of the to alert your doctor of all been logged.
nation products (like TheraFlu, positive vote. medications you take so they You can comment on this
NyQuil, Vicodin, Percocet) Dr. Kelly Shields, assis- can track your aceta- story at www.limaohio.com.
tant professor of pharmacy minophen levels.
• Have only one strength of Liquid practice at Ohio Northern On its Web site, Tylenol is
Tylenol available University, thinks some of advising people not to exceed
• If prescription acetaminophen the changes will be benefi- the recommended dosage.
combination products continue to be cial and can be easily imple- “It’s when people take
marketed, standardize information mented, such as more more than the rec-
given to consumers and require a prominent warning labels ommended
warning label and one strength of liquid d o s e
acetaminophen.
Dosage guide: “Having only one strength
Extra-strength Tylenol pills have 500 of Liquid Tylenol would help
milligrams of acetaminophen apiece. parents avoid an accidental
Currently, the highest safe level is 4 overdose when treating
grams a day, which means you can children,” Shields said.
only safely take eight pills a day. Shields also thinks
reducing dosage could
be easily implement-
ed. But Karen Riley,
spokeswoman for the
FDA, said the process
involves strenuous
analysis.