Maximum Tylenol Dosage to Be Reduced to Avoid Liver Failure


October 24, 2011

Johnson and Johnson (J&J) once again recently reduced the dosage recommendations for Tylenol (generic: acetaminophen) because of continuing concerns about the risk of liver failure.

The pharmaceutical company announced in August that it would be changing its dosage guidelines on Extra Strength Tylenol to further address the issue of accidental overdose of acetaminophen, the active ingredient in Tylenol. Extra Strength Tylenol is one of the products that contain acetaminophen, which have been in short supply because of numerous recent recalls linked to adverse side effects including liver damage and quality control issues. Acetaminophen overdoses send an estimated 56,000 people per year to the hospital and tragically claim the lives of 450 people per year according to some media reports.

The new maximum daily dose of Maximum Strength Tylenol was reduced to six pills or 3,000 milligrams per day as opposed to the current maximum of 8 pills and 4,000 milligrams per day. McNeil Consumer Healthcare Division, a subsidiary of J&J, also indicated that it would be reducing the maximum daily dosage indications on Regular Strength Tylenol and other adult pain relief medications that contain acetaminophen.

Acetaminophen is also the active pain relief ingredient in Percocet and Vicodin and literally thousands of over-the-counter cold and flu medicines to relieve fever, headache, sore throat and pain. A key issue is that many people who are sick combine Tylenol and other prescription or over-the-counter medications that contain acetaminophen so that they have no idea how much of the drug they are actually ingesting. The risk of liver failure from an acetaminophen overdose is compounded because it is listed on many prescription drug labels with the abbreviation APAP.

The danger of acetaminophen liver damage has long been recognized by the U.S. Food and Drug Administration (FDA). Acetaminophen overdose is considered the leading cause of liver failure in the U.S. A panel of advisers to the Food and Drug Administration proposed sweeping limits on acetaminophen due to unintentional overdoses that have led to acute liver failure and death. The FDA panel recommended that the maximum daily dose be reduced from 4,000 milligrams all the way down to 2,600 milligrams. Despite the panel’s recommendations, two years have passed with the drug company only recently planning to reduce the recommended maximum daily dosage to 3,000 milligrams. Approximately 10 percent of acetaminophen-related deaths occurred at dose levels between 2,000 mg and 4,000 mg.

The 2009 FDA panel also recommended that the maximum dosage of a single over-the-counter pill be reduced from the current level of 500 milligrams to 325 milligrams. Among the panels other recommendations was that the sale of prescription pain medications that combine acetaminophen with opiods, such as Vicoden and Percocet be banned.

The FDA panel review in 2009 was not the first time that the FDA addressed the dangers of acetaminophen overdose. The FDA proposed new warnings be added to over-the-counter pain medications containing acetaminophen as early as 2002. However, the FDA did not propose a rule directing that acetaminophen products contain a warning of liver damage on its packaging until 2006. This warning, which was not actually placed on packaging until 2009, identified an even more serious risk of liver damage when acetaminophen was taken in high doses or used with alcohol.

If you or a loved one has suffered liver damage or liver failure that you believe may be related to your use of acetaminophen, our Georgia acetaminophen injury lawyers can evaluate your case to determine whether you have a right to seek financial compensation. Our Georgia Tylenol injury lawyers are available to assist clients throughout all of Georgia and the Southeast, including but not limited to Albany, Athens, Atlanta, Augusta, Columbus, Gainesville, Macon, Marietta, Rome, Roswell, Savannah, Smyrna, Valdosta, Warner Robins and all smaller cities and rural areas in the state. No matter where you are located our attorneys are just a phone call away, and we will even come to you. Call us 24 hours a day/7 days a week for your Free Consultation at 1-800-LAW-NEED (1-800-529-6333). You can also visit us online at www.montlick.com and use our Free Case Evaluation Form or 24-hour Live Online Chat.

Category: Personal Injury

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