FDA LOWERS THE ACETAMINOPHEN DOSAGE LIMIT
& PROPOSES BLACK BOX WARNING

On January 13, 2011 the Food and Drug Administration (FDA) lowered the limit of acetaminophen allowed to be included in prescription drugs to only 325 milligrams per dose. The FDA also mandated an update to labels of all prescription combination acetaminophen products to warn of the potential risk for severe liver injury. There is a wide array of both prescription and over the counter drugs that include acetaminophen (see list of drugs at the bottom of this page) and prior to this new limit, many of the prescription medications had up to 750 milligrams of acetaminophen per dose. The FDA also now proposes inclusion of their most severe “Black Box” warning on all prescription products that contain acetaminophen.

Sandra Kweder, M.D., deputy director of the Office of New Drugs in FDA’s Center for Drug Evaluation and Research (CDER) said, “FDA is taking this action to make prescription combination pain medications containing acetaminophen safer for patients to use. Overdose from prescription combination products containing acetaminophen account for nearly half of all cases of acetaminophen-related liver failure in the United States; many of which result in liver transplant or death.”

TAKING MORE ACETAMINOPHEN THAN YOU KNOW. WHAT IS APAP?

“APAP” is an abbreviation for acetaminophen that many drug-makers use as shorthand in the list of ingredients on their drug packaging. Even if the prior dosage of acetaminophen had been an appropriate amount, it is not uncommon for users to accidentally exceed recommended dosage limits by taking more than one medication that includes acetaminophen at a time without realizing it because they do not recognize that “APAP” is, in fact, also acetaminophen! Some of the most popular drugs that use the abbreviation “APAP” are Percocet, Vicodin, and Tylenol with Codeine, among others.

WHAT IS ACETAMINOPHEN?

Acetaminophen was approved by the United States Food and Drug Administration (FDA) in 1951. Acetaminophen, known as Paracetamol internationally, is a pain reliever and fever reducer. Acetaminophen is most commonly sold under the brand Tylenol, but it is an ingredient in hundreds of brands both prescription and over the counter (OTC). It is frequently found in cold and flu medications. Acetaminophen has been linked to liver damage and failure.

ACETAMINOPHEN LIVER DAMAGE/FAILURE

ACETAMINOPHEN LIVER DAMAGE/FAILUREWhile there are claims of Acetaminophen’s general safety at recommended doses, acute overdoses can cause potentially fatal liver damage. There is also a chance for some users that a normal dose can carry the same risk. The liver is responsible for metabolizing drugs, so once toxic levels of acetaminophen occur in the liver, the natural antioxidant defenses of the body are overwhelmed. When this happens, the liver is damaged by the buildup of dangerous toxins. Scientists at the University of North Carolina, Chapel Hill recently conducted a study, now published in the Journal of the American Medical Association, that showed that in some cases 44% of participants who took acetaminophen, either alone or in combination with another drug, over a two week time frame, showed abnormal elevations of a liver enzyme that is known to be a precursor to liver damage.

Paracetamol toxicity is the leading cause of liver failure. Acetaminophen is to blame for the majority of drug overdoses in the United States. More than 30,000 cases of Acetaminophen overdose are reported per year, according to the American Association of Poison Control Centers. Overdoses of Acetaminophen can lead to liver failure, which requires treatment or can necessitate a liver transplant. Liver failure that necessitates a liver transplant is particularly devastating. Thousands of people in the United States are currently waiting for livers. A liver transplant is also one of the most expensive procedures in modern medicine. If left untreated, liver failure can result in death.

So adverse were the potential health risks of Acetaminophen that even before the recent change in dosage to prescriptions drugs containing acetaminophen noted above, the FDA advisory committee recommended restrictions to lower the maximum dosage and put warnings on the labels of over the counter drugs containing Acetaminophen in 2009. The FDA’s concern is that the former recommended maximum dose was shown to produce alterations in hepatic (liver) function. Unfortunately the many manufactures of prescription drugs containing Acetaminophen have three years to alter the amount in their products, so there are still drugs on the market with suggested maximum doses at harmful levels and without proper labeling to explain the risks to consumers.

SYMPTOMS OF LIVER DAMAGE

One of the most dangerous aspects of liver failure is that sometimes its victims don’t have symptoms. For those who do experience symptoms, they most often begin with nausea and vomiting in the first 24 hours. In the next 12 to 24 hours (the latent phase), the patient may have a feeling of wellness. It’s after this time, approximately 48 and sometimes as much as 72 hours after the overdose, liver blood test begin to appear abnormal. Tests at this time should provide an accurate outlook on whether the patient will be able to undergo treatment or will need a liver transplant. Patients who don’t receive these tests could not be aware that they have experienced liver damage. Untreated liver damage can result in death, often within a few days of Acetaminophen overdose.

If you or someone you care about has been injured by a product with Acetaminophen (See comprehensive list below), contact the lawyers at Oshman & Mirisola for a free and confidential case evaluation. We will find answers, hold negligent companies responsible, and fight to get you the compensation you deserve.

Acetaminophen Brands: Brands Containing Acetaminophen:
Acephen 666 Cold Preparation
Aceta Aceta-Gesic Actifed Cold & Sinus Acuflex
Actamin Alagesic
Adprin B Ali Flex Alidrin
Anacin AF Alka-Seltzer Cold and Sinus
Anacin-3 Maximum Strength Alka-Seltzer Plus Cold Formula
Apacet Alka-Seltzer Plus Cold Liquigel
Apara Alka-Seltzer Plus Cold and Sinus
Apra Alka-Seltzer Plus Cough and Cold Liquigel
Arthritis Foundation MS Alka-Seltzer Plus Flu Liquigels
BF-Paradac Alka-Seltzer Plus Night Time Cold Liquigel
Bactimicina Alka-Seltzer Plus Night Time Reformulated Dec 2006
Bromo Seltzer Allay
Childrens Panadol Allerest Headache Strength
Childrens Tylenol Allerest No Drowsiness
Comtrex Sore Throat Relief Allerest Sinus
Conacetol Alpain
Dolono Alumadrine
Dolono Infant Americet
Ed-APAP Amidrine
Elixsure Fever/Pain Anabar
Feverall Anacin Advanced Headache Formula
Genapap Anacin P.M. Aspirin Free
Genapap Extra Strength Anatuss Anexsia
Genebs Anexsia 10/660
Gericet Anexsia 5/325
Halenol Anexsia 5/500
Infantaire Anexsia 7.5/325
Liquiprin Anexsia 7.5/650
Little Fevers Anolor 300
Lopap brand of acetaminophen Anolor DH5
Mapap Anoquan
Mapap Junior Strength Apagesic
Mardol Apapgesic
Masophen Arcet
Meda Cap Arthriten
Neopap Supprettes Arthritis Foundation
Pain-Eze Axocet
Panadol BP Poly-650
Panadol Jr. Backprin
Panex Balacet
Panex 500 Bancap HC
Paramol Bayer Select
Pediacare Children’s Fever Reducer Pain Reliever Bayer Select Decongestant
Pediacare Infant Fever Reducer Bayer Select Max Strength Night Time Pain
Pediapap Bayer Select Sinus Pain Formula
Q-Nol Be-Flex Plus
Redutemp BeFlex
Ridenol Benadryl Allergy Cold Reformulated Jun 2007
S-T Febrol Benadryl Allergy Sinus Headache Reformulated Jun 2007
Silapap Benadryl Cold
St. Joseph Aspirin-Free Benadryl Severe Allergy Sinus Headache Reformulated Jun 2007
T-Painol Bromaline Plus
T-Painol Extra Strength Bucet
T-Panol Bupap
Tactinal Butex Forte
Tempra By Ache
Tempra 1 Cafgesic
Tempra 2 Capital and Codeine
Tempra 3 Cephadyn
Tempra Quicklets Ceta Plus
Triaminic Fever & Pain Cetazone
Triaminic Infant Drops Reformulated Nov 2010 Child Tylenol Cold Multi-Symptom Plus Cough
Tycolene Childrens Tylenol Allergy-D
Tylenol Childrens Tylenol Cold
Tylophen Childrens Tylenol Cold Multi-Symptom
Uni-Ace Childrens Tylenol Cold Plus Cough
Uni-Ace Child Childrens Tylenol Flu
Uniserts Childrens Tylenol Plus Cold & Allergy
Vitapap Chlor-Trimeton Sinus
XS No Aspirin PR Co-Apap
XS Pain Reliever Co-Gesic
Cocet 650/30
Cocet 650/60
Codimal
Codrix 500/15
Codrix 500/30
Codrix 500/60
Coldonyl
Colrex
Combiflex
Combiflex ES
Comtrex Allergy Sinus
Comtrex Allergy Sinus Maximum Strength
Comtrex Allergy Sinus Night and Day
Comtrex Cold and Cough Nighttime
Comtrex Cold and Cough Non Drowsy
Comtrex Cold and Flu Maximum Strength Liquid
Comtrex Cold and Flu Maximum Strength Reformulated Aug 2006
Comtrex Deep Chest Cold Non Drowsy
Comtrex Maximum Strength Cold Relief
Comtrex NT
Comtrex Non Drowsy Liquigel
Comtrex Non-Drowsy
Congespirin
Congestant
Congestant D
Contac Cold and Flu Maximum Strength
Contac Cold and Flu Non Drowsy Maximum Strength
Contac Severe Cold and Flu Maximum Stength
Contac Severe Cold and Flu Non Drowsy
Contac Sinus
Contragesic
Coricidin
Coricidin D
Coricidin D Cold
Coricidin HBP Flu Maximum Strength
Coricidin HBP Nighttime Multi-Symptom Cold
Coricidin Night Time Cold Relief
Cotabflu
Covangesic
Darvocet A500
Darvocet-N
Dayquil
Dayquil Liquicaps Reformulated Apr 2009
Dayquil Sinus
Delsym Adult Night Time Multi-Symptom
Delsym Night Time Cough and Cold
Diabetic Tussin Night Time Formula
Dimetapp Allergy Sinus
Dimetapp Cold and Fever
Dimetapp Cold and Flu
Dimetapp Nighttime Flu Reformulated Sep 2007
Dolacet
Dolagesic
Dolgic
Dolgic LQ
Dolgic Plus
Dolmar
Dologesic
Dolorex Forte
Dristan Cold Maximum Strength
Dristan Cold Multi Symptom Formula
Dristan Cold Non-Drowsy
Drixoral Cough/Sore Throat
Drixoral Sinus
Dryphen
Duadacin
DuoCet
Duogesic
Durabac
Durabac Forte
Duradrin
Duraflu
Duratuss A
EX-Pain Reliever
EZ III
Ed Flex
Emagrin Forte
Endocet 10/325
Endocet 10/650
Endocet 5/325
Endocet 7.5/325
Endocet 7.5/500
Endolor
Epidrin
Esgic
Esgic-Plus
Ex-Pain
Excedrin Excedrin Back & Body
Excedrin PM
Excedrin Quick Tab
Excedrin Sinus
Excedrin Sinus Headache
Excedrin Tension Headache
Ezol
Femcet
Fioricet
Fioricet with Codeine
Fiorpap
Flextra
Flextra DS
Flextra Plus
Frenadol
G-1
Gelpirin-CCF
Genace brand of acetaminophen/aspirin/caffeine
Genacol
Genacol Maximum Strength
Genapap C
Genapap PM (Genapap Sinus
Genasec
Gendecon
Geone
Goody’s Body Pain
Goody’s Cool Orange Extra Strength
Goody’s Extra Strength
Goody’s PM
HEXAFLU
Hy-Phen
Hycet
Hyco-pap
Hycomed
Hycomine Compound
Hydrocet
Hydrogesic
Hyflex
Hyflex DS
I.D.A.
Ide-cet
Iso-Acetazone
Isocet
Isocom
Kolephrin
Lagesic
Leg Ease PM
Legatrin PM
Levacet
Liquicet
Little Colds
Lobac
Lorcet 10/650
Lorcet HD
Lorcet Plus
Lorsin
Lortab 10/500
Lortab 2.5/500
Lortab 5/500
Lortab 7.5/500
Lurline PMS
Lusonex Plus
Lynox 10/300
Lynox 2.5/300
Lynox 5/300
Lynox 7.5/300
Magnacet 10/400
Magnacet 2.5/400
Magnacet 5/400
Magnacet 7.5/400
Major-gesic
Mapap Cold
Mapap PM
Mapap Sinus
Mapap Sinus Congestion and Pain
Margesic #3
Margesic
Margesic-H
Marten-Tab
Masophen PM
Maxidone
Maxiflu
Maxiflu DM
Maximum Acetaminophen
Medigesic
Medipain 5
Midchlor
Midol Maximum Strength Menstrual
Midol Maximum Strength Teen Formula
Midol PM
Midol PMS Maximum Strength
Midrin
Migquin
MigraTen
Migralam
Migran-A
Migrapap
Migratine
Migrazone
Migrend
Migrex
Minotal
Mitride
Mygracet
Mygrex
Narvox
Non-Drowsy Sinus Maximum Strength
Nonbac
Norco 10/325
Norco 5/325
Norco 7.5/325
Norel SR
Novagesic
NyCair
NyQuil Alchohol Free
NyQuil Cold/Flu Relief
NyQuil D
Nyquil Cold & Flu
Nyquil Cold Medicine
Nyquil Liquicap
Oncet
Onset Forte
Orbivan
Ornex
Ornex Maximum Strength
PSE Sinus
Pacaps
Pain-Gesic
Pamprin ES Multi-Symptom Relief Formula
Pamprin Maximum Pain
Panacet
Panlor
Panlor DC Reformulated Jan 2008
Panlor SS
Panritis Forte
PediaCare Children’s Plus Cough and Sore Throat
Pediacare Children’s Plus Cough and Runny Nose
Percocet 10/325
Percocet 10/650
Percocet 2.5/325
Percocet 5/325
Percocet 7.5/325
Percocet 7.5/500
Percogesic
Percogesic Extra Strength
Perisine
Perloxx 10/300
Perloxx 2.5/300
Perloxx 5/300
Perloxx 7.5/300
Pharmagesic
Phenagesic
Phenapap
Phenapap Sinus Improved
Phenaphen with Codeine #3
Phenaphen with Codeine #4
Phenco-Care
Phenflu
Phenflu DM
Phenylgesic
Phlemgesic
Phrenilin
Phrenilin with Caffeine and Codeine
Poly-Vent Plus
Polygesic
Premesyn PMS
Primalev 300/2.5
Primlev 10/300
Primlev 5/300
Primlev 7.5/300
Procet 5/325
Procet 7.5/325
Prodrin
Promacet
Prominol
Propacet
Protid
Pseudoephedrine Sinus
Pyregesic
Pyrroxate
Q-Gesic
QFlex
Quala Cet
Relagesic
Repan
Repan CF
Respa C&C
RhinoFlex 650
Rhinocaps
Rhinogesic
Robitussin Cold Cough and Flu
Robitussin Honey Flu Nighttime
Robitussin Honey Flu Non-Drowsy
Robitussin Night Cold
Robitussin Night Relief
Robitussin Night Time Cough, Cold & Flu
Roxicet
Roxicet 5/325
Roxicet 5/500
SM Night Time Cold & Flu
Saleto
Saleto-D
Sedapap
Simplet
Sinapap
Sinapils
Sinarest
Sinarest Extra Strength
Sinarest Sinus
Sine-Aid
Sine-Off Cold and Cough
Sine-Off Maximum Strength Reformulated Sep 2008
Sine-Off Sinus and Cold
Singlet brand of APAP/chlorpheniramine/pseudoephedrine
Sinulin
Sinumed
Sinus Aid
Sinus Maximum Strength
Sinustab
Sinutab Ex-Strength
Sinutab Maximum Strength
Sinutab Regular Strength
Sinutab Sinus
Sominex Pain Relief Formula
Staflex Reformulated Dec 2007
Stagesic 10/250
Stagesic 5/500
Sudafed Cold and Cough Liquicaps
Sudafed Cold and Sinus
Sudafed PE Cold & Cough
Sudafed PE Nighttime Cold
Sudafed PE Severe Cold
Sudafed PE Sinus Headache
Sudafed PE Triple Action
Sudafed Severe Cold Sudafed Sinus
Sudafed Sinus Headache
Sudafed Sinus Nighttime Plus Pain Relief
Sudafed Triple Action
Sudogest Sinus Maximum Strength
Supac
Suphedrin Sinus
T-Gesic
Talacen
Tavist Allergy/Sinus/Headache
Tavist Sinus
Taxadone
Tenake
Tencet
Tencon
Theraflu Cold & Sore Throat Reformulated Sep 2008
Theraflu Daytime Severe Cold & Cough
Theraflu Daytime Severe Cold
Theraflu Flu & Chest Congestion
Theraflu Flu & Sore Throat Reformulated Sep 2008
Theraflu Flu and Cold Medicine Powder
Theraflu Max-D
Theraflu Nightime Maximum Strength
Theraflu Nighttime Severe Cold & Cough
Theraflu Nighttime Severe Cold
Theraflu No Drowsiness Maximum Strength
Theraflu Severe Cold & Congestion Non-Drowsy
Theraflu Severe Cold Nighttime
Theraflu Sinus
Theraflu Sore Throat Maximum Strength
Theraflu Warming Cold & Chest Congestion
Theraflu Warming Relief
Theraflu Warming Severe Cold
Theraflu, Flu, Cold, and Cough
Trezix
Triad
Triaminic Cold and Fever
Triaminic Cough & Sore Throat Reformulated Jul 2007
Triaminic Flu Cough & Fever
Triaminic Multi-Symptom Fever
Triaminic Softchews Allergy Sinus
Triaminic Softchews Cough & Sore Throat Reformulated Jul 2007
Triaminic Sore Throat Formula
Triaminicin Reformulated Sep 2008
Triaprin
Tricom brand of acetaminophen / chlorpheniramine / pseudoephedrine
Trital
Two-Dyne
Tylagesic
Tylefon
Tylenol Allergy
Tylenol Allergy Multi-Symptom
Tylenol Allergy Multi-Symptom Nighttime
Tylenol Allergy Sinus Caplet
Tylenol Allergy Sinus Gelcap
Tylenol Allergy Sinus Geltab
Tylenol Allergy Sinus NightTime
Tylenol Chest Congestion
Tylenol Children’s Multi-Symptom Cold Plus
Tylenol Children’s Plus Cold & Cough
Tylenol Children’s Plus Cold
Tylenol Childrens Plus Cough & Runny Nose
Tylenol Childrens Plus Cough & Sore Throat
Tylenol Cold & Flu Severe Day Time
Tylenol Cold & Flu Severe NightTime
Tylenol Cold
Tylenol Cold Complete Formula
Tylenol Cold Head Congestion Daytime
Tylenol Cold Head Congestion Nighttime
Tylenol Cold Head Congestion Severe
Tylenol Cold Infants Reformulated Jun 2007
Tylenol Cold Multi-Symptom Daytime
Tylenol Cold Multi-Symptom Nighttime
Tylenol Cold Multi-Symptom Nighttime Liquid
Tylenol Cold Multi-Symptom Severe Daytime
Tylenol Cold No Drowsiness
Tylenol Cold Relief
Tylenol Cold Relief Nighttime
Tylenol Cold Severe Congestion
Tylenol Cold Severe Congestion Non-Drowsy
Tylenol Cold and Flu
Tylenol Cold and Flu No Drowsiness
Tylenol Cough & Sore Throat Night Time
Tylenol Cough
Tylenol Cough Liquid with Decongestant
Tylenol Cough and Sore Throat Daytime
Tylenol Extra Strength P.M.
Tylenol Flu Maximum Strength
Tylenol Flu NightTime
Tylenol Infants Cold Plus Cough Reformulated Sep 2008
Tylenol Nightime Flu Gelcap Maximum Strength
Tylenol PM
Tylenol Severe Allergy
Tylenol Sinus Childrens
Tylenol Sinus Congestion Daytime
Tylenol Sinus Congestion Nighttime
Tylenol Sinus Congestion and Pain Daytime
Tylenol Sinus Congestion and Pain Severe
Tylenol Sinus Maximum Strength
Tylenol Sinus NightTime
Tylenol Sinus Severe Congestion
Tylenol Sore Throat Nighttime Tylenol Warming Cough & Sore Throat Nightime
Tylenol with Codeine #2
Tylenol with Codeine #3
Tylenol with Codeine #4
Tylenol with Codeine
Tylox
Ugesic
Ultracet
Uni-Case
Uni-Perr
Unisom with Pain Relief
Va-zone
Valorin Extra
Vanacet
Vanquish
Vendone
Vicks 44 Cold, Flu and Cough
Vicks Formula 44M
Vicodin 10/660
Vicodin 5/500
Vicodin 7.5/750
Vidone
Vistra
Vitoxapap
Vopac
Wal-Flu Severe Cold and Cough
Womens Tylenol Menstrual Relief
Wygesic
X-Pain Relief
Xodol 10/300
Xodol 5/300
Xodol 7.5/300
Xolox
Zamicet
Zebutal
Zerlor
Zflex
Zgesic
Zicam Multi-Symptom Cold and Flu Daytime
Zicam Multi-Symptom Cold and Flu Nighttime
Zolvit
Zydone 10/400
Zydone 5/400
Zydone 5/500
Zydone 7.5/400
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