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
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 The Oshman Firm 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 |
About Ted Oshman
Ted Oshman has been with The Oshman Firm since 1988 serving clients for over 25 years. Learn more about Ted's background and featured practice areas here.
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