Acetaminophen: Drug found in Tylenol causing a stir
1
L IMA — When you see the all-too-familiar white pill splashed red with the “Tylenol” printed on its side, do you fear the possibility of dying if you take it? Well, that’s what’s on the mind of the 37-member advi- sory committee for the Federal Drug Administration measuring the effects of acetaminophen, the pain reliever found in Tylenol. On June 29 and 30, the FDA held a public advisory committee meeting to dis- cuss the links between aceta- minophen and liver failure and ask for suggestions to make the drug safer. The advisory board sug- gested a slew of changes to the FDA, and nine different proposed ideas were voted on. Proposed ideas varied from lowering the maximum daily dosage, lowering the adult dosage from 1,000 mil- ligrams to 650 milligrams, having only one strength of Liquid Tylenol available, and eliminating the prescription acetaminophen combination products (such as Vicodin and Percocet). All but one of the proposed ideas received more than 50 percent of votes in favor, with two gaining 97 percent of the positive vote. Dr. Kelly Shields, assis- tant professor of pharmacy practice at Ohio Northern University, thinks some of the changes will be benefi- cial and can be easily imple- mented, such as more prominent warning labels and one strength of liquid acetaminophen. “Having only one strength of Liquid Tylenol would help parents avoid an accidental overdose when treating children,” Shields said. Shields also thinks reducing dosage could be easily implement- ed. But Karen Riley, spokeswoman for the FDA, said the process involves strenuous analysis. “If we decide to change dosage, it will take at least a year and then we have to study whether the lower dosage is effective,” Riley said. Shields said she’d be con- cerned if medications like Vicodin and Percocet were removed. “You can’t pull it off the market without thinking about a replacement and more options for pain relief,” Shields said. “Vicodin is the top-selling pain management medicine in the U.S.” Shields also worries about the proposal to make 1,000 milligram dosages of Tylenol only available through pre- scription. “I don’t know if that will accomplish much,” Shields said. “People can just take two of the 500 milligram pills.” Shields said the concerns surrounding acetaminophen come when someone con- sumes high doses. The cur- rent maximum dosage is 4 grams a day, which equals eight pills. “Too much acetaminophen occurs when people use three to four different products that have Tylenol as a com- ponent, such as NyQuil,” Shields said. Shields said its important to alert your doctor of all medications you take so they can track your aceta- minophen levels. On its Web site, Tylenol is advising people not to exceed the recommended dosage. “It’s when people take more than the rec- ommended d o s e either intentionally, often because they think it will work better, which is not the case, or unintentionally, often because they don’t real- ize that several products they are taking at the same time (both prescription and over- the-counter) contain aceta- minophen,” according to Tylenol’s Web site. This is not the first time the FDA has been presented with ideas like these. Shields said the advisory board’s pro- posal to the FDA in 2002 was similar. “Those recommendations didn’t go through, and so I think the FDA will act on some of the recent proposals — but not all,” Shields said. Since the late 1990s the FDA has been creating new ways to educate aceta- minophen users on its effects and not exceeding the recom- mended amount. Riley said the proposal will be reviewed and numerous options discussed. The next steps will be decided in three to six months. “The implementation process takes a lot longer,” Riley said. Consumers may submit their opinions on the FDA Web site about this subject. About 20 comments have been logged. You can comment on this story at www.limaohio.com. Drug found in Tylenol causing a stir By HANNAH POTURALSKI • [email protected] • 419-993-2091 Acetaminophen AT A GLANCE For details about the proposed changes, visit www.fda.gov. Symptoms that may indicate liver disease: • Severe nausea • Yellowing eyes or skin • Dark urine • Stomach pain • Extreme fatigue The FDA’s proposed ideas: • Lower the maximum daily dosage • Lower the adult dosage to 650 milligrams • Make the 1,000 milligram dosage available only through prescription • Set a limit on package sizes of nonprescription acetaminophen products • Eliminate acetaminophen combi- nation products (like TheraFlu, NyQuil, Vicodin, Percocet) • Have only one strength of Liquid Tylenol available • If prescription acetaminophen combination products continue to be marketed, standardize information given to consumers and require a warning label Dosage guide: Extra-strength Tylenol pills have 500 milligrams of acetaminophen apiece. Currently, the highest safe level is 4 grams a day, which means you can only safely take eight pills a day.
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Transcript of Acetaminophen: Drug found in Tylenol causing a stir
GROWING A HEALTHY COMMUNITYHealth Fair and Farmers’ Market
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QI am a 77 year-oldwoman who developed
swelling of the soft tissuesinside my mouth and lipswith a loss of taste afterquitting smoking. Couldthat have caused it?
— A.G., Lexington, S.C.
AThe swelling soundslike a case of
“angioedema.” It’s aswelling similar to hives,but unlike hives, theswelling of angioedemaoccurs below the surfacerather than above it. I’mnot sure what caused yourangioedema event, but itwould be more likelycaused by an allergic reac-tion to something you ateor ingested, rather than bythe cessation of cigarettesor anything else.
There are a number ofthings that are known tocause angioedema: animaldander, medication reac-tion (e.g., penicillin, sulfaand ACE inhibitor bloodpressure drugs), certainfoods, insect bites, pollen,acute viral illnesses,leukemia, lupus and expo-sure to extreme sun, coldor heat. That said, oftenthe cause of angioedema isnever found.
The good news is that aslong as the swelling does-n’t involve your airway,you’ll be fine within a fewdays. For moderate symp-toms, after a few days ofantihistamines and a shortcourse of steroids, it’s“all’s well that ends swell.”For more severe symptomsthat involve the airway, ashot of epinephrine(adrenaline) may be need-ed. Any time angioedemacauses shortness of breathor difficulty swallowing,immediately go to the hos-pital or call 911.
QI developed “Stevens-Johnson Syndrome”
after receiving hydro-chlorothiazide for myblood pressure. I ended upwith a severe allergic rashwith blisters all over mybody and inside my mouth.Could you write somethingabout this to educate meand others about this terri-ble condition?
— L.L., Marietta, Ga.
AYou developed a severeallergic reaction, most
likely from sulfa part of thewater pill. What’s differentabout your rash from ausual drug allergy is thatthere’s severe rash, skinblistering and breakdown,fever, swelling of eyelids,flu-like symptoms and blis-ters of the mouth, eyes,nose and genital area.
Almost any medicationthat can cause an allergicreaction. That includesantibiotics like penicillinand sulfa drugs, anti-seizure medications like
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What causesangioedema?
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L IMA — When you seethe all-too-familiarwhite pill splashed red
with the “Tylenol” printedon its side, do you fear thepossibility of dying if youtake it?
Well, that’s what’s on themind of the 37-member advi-sory committee for theFederal Drug Administrationmeasuring the effects ofacetaminophen, the painreliever found in Tylenol.
On June 29 and 30, theFDA held a public advisorycommittee meeting to dis-cuss the links between aceta-minophen and liver failureand ask for suggestions tomake the drug safer.
The advisory board sug-gested a slew of changes tothe FDA, and nine differentproposed ideas were votedon.
Proposed ideas varied fromlowering the maximum dailydosage, lowering the adultdosage from 1,000 mil-ligrams to 650 milligrams,having only one strength ofLiquid Tylenol available, andeliminating the prescriptionacetaminophen combinationproducts (such as Vicodinand Percocet).
All but one of the proposedideas received more than 50percent of votes in favor, withtwo gaining 97 percent of thepositive vote.
Dr. Kelly Shields, assis-tant professor of pharmacypractice at Ohio NorthernUniversity, thinks some ofthe changes will be benefi-cial and can be easily imple-mented, such as moreprominent warning labelsand one strength of liquidacetaminophen.
“Having only one strengthof Liquid Tylenol would helpparents avoid an accidentaloverdose when treatingchildren,” Shields said.
Shields also thinksreducing dosage couldbe easily implement-ed. But Karen Riley,spokeswoman for theFDA, said the processinvolves strenuousanalysis.
“If we decide to changedosage, it will take at least ayear and then we have tostudy whether the lowerdosage is effective,” Riley said.
Shields said she’d be con-cerned if medications likeVicodin and Percocet wereremoved.
“You can’t pull it off themarket without thinkingabout a replacement andmore options for pain relief,”Shields said. “Vicodin is thetop-selling pain managementmedicine in the U.S.”
Shields also worries aboutthe proposal to make 1,000milligram dosages of Tylenolonly available through pre-scription.
“I don’t know if that willaccomplish much,” Shieldssaid. “People can just taketwo of the 500 milligrampills.”
Shields said the concernssurrounding acetaminophencome when someone con-sumes high doses. The cur-rent maximum dosage is 4grams a day, which equalseight pills.
“Too much acetaminophenoccurs when people use threeto four different productsthat have Tylenol as a com-ponent, such as NyQuil,”Shields said.
Shields said its importantto alert your doctor of allmedications you take so theycan track your aceta-minophen levels.
On its Web site, Tylenol isadvising people not to exceedthe recommended dosage.
“It’s when people takemore than the rec-o m m e n d e dd o s e
either intentionally, oftenbecause they think it willwork better, which is not thecase, or unintentionally,often because they don’t real-ize that several products theyare taking at the same time(both prescription and over-the-counter) contain aceta-minophen,” according toTylenol’s Web site.
This is not the first timethe FDA has been presentedwith ideas like these. Shieldssaid the advisory board’s pro-posal to the FDA in 2002 wassimilar.
“Those recommendationsdidn’t go through, and so Ithink the FDA will act onsome of the recent proposals— but not all,” Shields said.
Since the late 1990s theFDA has been creating newways to educate aceta-minophen users on its effectsand not exceeding the recom-mended amount.
Riley said the proposal willbe reviewed and numerousoptions discussed. The nextsteps will be decided in threeto six months.
“The implementationprocess takes a lot longer,”Riley said.
Consumers may submittheir opinions on the FDAWeb site about this subject.About 20 comments havebeen logged.You can comment on thisstory at www.limaohio.com.
Drug found in Tylenol causing a stirBy HANNAH POTURALSKI • [email protected] • 419-993-2091
Acetaminophen
AT A GLANCE
For details about the proposed
changes, visit www.fda.gov.
Symptoms that may
indicate liver disease:
• Severe nausea• Yellowing eyes or skin• Dark urine• Stomach pain• Extreme fatigue
The FDA’s proposed ideas:
• Lower the maximum daily dosage • Lower the adult dosage to 650milligrams• Make the 1,000 milligram dosageavailable only through prescription• Set a limit on package sizes ofnonprescription acetaminophenproducts• Eliminate acetaminophen combi-nation products (like TheraFlu,NyQuil, Vicodin, Percocet)• Have only one strength of LiquidTylenol available• If prescription acetaminophencombination products continue to bemarketed, standardize informationgiven to consumers and require awarning label
Dosage guide:
Extra-strength Tylenol pills have 500milligrams of acetaminophen apiece.Currently, the highest safe level is 4grams a day, which means you canonly safely take eight pills a day.
NATE WARNECKE illustra
tion• The Lima News
