J&J lowers Extra Strength Tylenol dosage to reduce overdose rise
Jul 29, 2011, 9:56 a.m.
WASHINGTON (Reuters) - Johnson & Johnson will lower the maximum daily dose for Extra Strength Tylenol to reduce risk of overdose, McNeil Consumer Healthcare announced on Thursday.
The move from eight pills per day to six is meant to encourage the appropriate use of acetaminophen, according to a release from the consumer healthcare company.
McNeil is a division of McNEIL-PPC, Inc., in turn a subsidiary of Johnson & Johnson.
"Acetaminophen is safe when used as directed," Dr. Edwin Kuffner, vice president of over-the-counter medical affairs and clinical research at McNeil, said in the release. "But, when too much is taken (overdose), it can cause liver damage.
More than 50 million Americans use acetaminophen each week to treat pain, fever, pains and other conditions associated with cold and flu symptoms, according to McNeil.
McNeil notified the U.S. Food and Drug Administration the new dosing instructions will appear on Extra Strength Tylenol products in the U.S. beginning fall 2011.
The company will also lower the maximum daily dose for Regular Strength Tylenol and other acetaminophen-containing products for adults starting in 2012.
The announcement follows a string of recalls of Tylenol and other nonprescription drugs for Johnson & Johnson in the past year.
In March 2011, U.S. health authorities said they would closely supervise three Johnson & Johnson manufacturing plants where quality-control lapses have led to recalls of more than 300 million bottles and packages of over-the-counter medicines.
That same month Johnson & Johnson reported that following repeated recalls it would make its U.S. over-the-counter business a separate organization.
(Reporting by Molly O'Toole; Editing by Jerry Norton)