According to press reports, acetaminophen-related liver problems cause 450 deaths and 56,000 emergency-room visits a year. The accidental taking of toxic doses of acetaminophen, the active ingredient in Tylenol and other pain and fever medications, is by far the most common cause of acute liver failure in the United States.
"People don't realize how many products contain acetaminophen," said Laura Bradbard, an FDA spokeswoman. Someone might take Tylenol for pain, then a cold remedy in the same day but not know they're exceeding the maximum safe dose. Acetaminophen is found in nearly 200 over-the-counter products, as well as some prescription painkillers like Percocet and Darvocet.
In addition to the danger of liver failure with acetaminophen overdoses, healthy adults taking the recommended dose of Tylenol as directed are also at risk for liver damage. A recent study published in the Journal of the American Medical Association shows that the maximum dose of Extra Strength Tylenol may be too high and can cause severely heightened levels of liver enzymes, an indicator of liver toxicity and an early sign of organ damage.
FDA Advisory Panels & Warnings on Acetaminophen
In July 2009, a U.S. Food and Drug Administration advisory panel recommended sweeping and substantial limits on acetaminophen, due to unintentional overdoses that have led to acute liver failure and death. The panel has suggested lowering the maximum daily dose to 2,600 milligrams from 4,000 mg and limiting the amount in a single over-the-counter pill to 325 mg, from 500 mg currently. Additionally, the advisory panel wishes to ban sales of prescription pain killers that combine opioids with acetaminophen, including Percocet and Vicodin.
This is not the first time the FDA has looked into the liver dangers associated with acetaminophen. In 2002, a FDA advisory panel recommended proposed new warnings about liver damage dangers on the labels of over-the-counter pain relievers such as aspirin, ibuprofen and acetaminophen. It wasn't until December 2006 that the FDA officially proposed such a rule, and suggested that products containing acetaminophen come in packaging that highlights the potential liver damage associated with use, particularly when taken in high doses or with a moderate amount of alcohol. This went into affect in April 2009.
Tylenol Liver Damage
Acetaminophen belongs to a class of drugs called analgesics and is used for the relief of fever as well as aches and pains associated with many conditions.
It is commonly associated with Tylenol brand pain reliever, but is also an active ingredient in a number of over-the-counter (such as Excedrin, Midol, Theraflu, Alka-Seltzer Plus Cold Medicine, NyQuil) and prescription (Vicodin and Percocet) drugs. The standard oral dose for adults is 325 to 650 mg every 4-6 hours, with a maximum daily dose of 4 grams.
According to a clinical study published in the Journal of the American Medical Association, even this safety maximum of 4 grams per day may be set too high. In another study published by Hepatology, findings show that consistent use of as little as 7.5 grams a day could lead to severe liver injury.
Furthermore, about 10% of acetaminophen-related deaths occurred at dose levels between 2,000 mg and 4,000 mg. Those who drink three or more alcoholic beverages per day or suffer from liver disease are particularly vulnerable.
Despite the information available concerning the dangers associated with overdoses of the drug, the number of unintentional acetaminophen poisoning cases has continued to increase.
Users most at risk for overdose include those with depression, chronic pain, alcohol/narcotic use, and those who take several acetaminophen-containing products at the same time -- for example, Tylenol for a headache and a second acetaminophen-containing product for cold symptoms.
In addition, some babies die every year because parents give them liquid acetaminophen instead of solutions that come in droppers and are prepared specially for infants. The two contain different concentrations of medication, but warning labels don't offer concrete guidance for how much is appropriate for babies.
Further adding to the confusion, Infants' Tylenol is concentrated to three times the strength of regular Children's Tylenol. In July 2006, a jury found the manufacturer negligent in a trial over the death of a one-year old boy from Infant's Tylenol which resulted in fatal acetaminophen toxicity.
Painkiller/Cold Medicine Liver Damage Lawsuit Claims
It has been alleged that drug manufacturers have failed to warn the general public that even a small amount of acetaminophen taken multiple times can lead to severe liver injury. Nor have drug manufacturers of products containing acetaminophen adequately warned the public of other over-the-counter pain and cold remedies that also contain acetaminophen so that patients not ingest multiple medicines containing acetaminophen at the same time.
Legal Rights of Patients
The law in most states provides several personal injury claims for persons who have been seriously injured by prescription or over-the-counter drugs with dangerous, undisclosed side effects. These claims include strict liability for a defective product, failure to warn, and negligence.
Damages sought against drug manufacturers for side effects and injuries include:
- Physical pain and suffering, mental anguish and physical impairment;
- Medical expenses associated with the allegedly defective product; and
- Loss of earnings and/or earning capacity.
In the case of a patient that dies, a wrongful death suit may be filed by the family.
Tylenol Acetaminophen Side Effects Lawyer
If you or a family member have suffered acute liver failure or other injuries due to acetaminophen overdose, you may be eligible to file a claim. Please click here to contact an attorney at Lieff Cabraser to discuss your legal rights at no cost or obligation. We will handle all inquiries with the strictest confidentiality and sensitivity. Inquiries from Canada and other nations are also welcome.
You are also welcome to call us toll-free at 1-800-541-7358; Visitors from Canada can call 1-415-956-1000. Please ask to speak with lawyer Fabrice Vincent.
Trademark Notice
Tylenol is a registered trademark of McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. Lieff Cabraser Heimann & Bernstein, LLP is in no way affiliated with McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. The trademarks, service marks, trade names, trade dress and products named in this site are used only to identify the products and for informational purposes only.
About Lieff Cabraser
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