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Did you know that between 1998 and 2003, acetaminophen was the leading cause of liver failure in the United States? Forty-eight percent of these cases were caused by accidental acetaminophen overdose.
A Centers for Disease Control report from 2007 found there are around 1,600 cases of liver failure each year and that the most common cause for this is acetaminophen.
Between the years 1990-1998, there were 56,000 emergency room visits, 26,000 hospitalizations, and 458 deaths due to acetaminophen use.
Various medical studies have found that when patients take acetaminophen along with another prescription drug, it makes it more dangerous and it makes the likelihood of overdose more common, as there may be additional acetaminophen in the prescription drug.
In 2005, there were 1,187 poisoning cases with single ingredient prescription drugs, 653 poisonings for combination drugs and 1,470 poisonings for prescription opioid drugs.
Due to the risk of severe liver injury from acetaminophen, regulatory authorities have recommended withdrawing combination prescription medications from the market, adding boxed warnings to the patient information leaflets regarding liver failure and limiting the amount of acetaminophen contained in a dose.
Acetaminophen products will now be limited to a maximum dosage of 325 mg per dose so that patients will be less likely to overdose accidentally.
There are many medications that are affected by this measure, including acetaminophen and caffeine products, Capital and Codeine, Tylenol with Codeine number 3, Tylenol with Codeine number 4, Esgic Plus, Fioricet, Fioricet with Codeine, Phrenilin with Caffeine and Codeine, Anexsia, Co-Gesic, Lortab, Norco, Vicodin, Zydone, Percocet, Roxicet, Roxilox, Tylox, Talacen and Ultracet.
Advice for Patients Using Prescription Pain Medication
• If worried about your medication, speak to your doctor.
• Acetaminophen is relatively safe when used as directed but all medicines have risks.
• Read the patient information leaflets for all drugs you are taking to make sure that your other prescription medications don’t contain acetaminophen.
• Don’t take more medication than directed.
• Don’t drink alcohol when taking acetaminophen.
• If you have an allergic reaction such as swelling of the face, mouth, throat, difficulty breathing, itching or a rash, stop taking the product and seek emergency medical help immediately.
• If you suffer any adverse events or liver problems after taking acetaminophen, you can report it to the United States Food and Drug Administration at:
https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
1. Source: U.S. Food and Drug Administration. Medical sources for acetaminophen risks are: Larson AM, Polson J, Fontana RJ, Davern TJ, Lalani E, Hynan LS, et al. Acute Liver Failure Study Group (ALFSG). Acetaminophen-induced acute liver failure: results of a United States multicenter, prospective study. Hepatology. 2005; 42:1364-72.
2. Bower WA, Johns M, Margolis HS, Williams IT, Bell BP. Population-based surveillance for acute liver failure. Am J Gastroenterol. 2007;102:2459-63.
3. Nourjah P, Ahmad SR, Karwoski C, Willy M. Estimates of acetaminophen (Paracetamol)-associated overdoses in the United States. Pharmacoepidemiol Drug Saf. 2006;15:398-405.
4. Lai MW, Klein-Schwartz W, Rodgers GC, Abrams JY, Haber DA, Bronstein AC, Wruk KM. 2005 Annual Report of the American Association of Poison Control Centers' national poisoning and exposure database. Clin Toxicol. 2006;44:803-932.
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Acetaminophen, the active ingredient in Tylenol as well as a litany of other over-the-counter and prescription medications, has been linked to liver failure - and even death. Always follow dosing directions and check your medications to not mix drugs. The FDA recently has been paying increased attention to this issue and their Safe Use Initiative as well. Regards, TM
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