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agate
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Joined: 17 May 2006
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 Posted: Sun Jul 31, 2011 5:56 pm Post subject: Tylenol maximum dose to be reduced |
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From MedPage Today, July 28, 2011:
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Tylenol Maker Lowers Maximum Dose
By Chris Kaiser, Cardiology Editor, MedPage Today
McNeil Consumer Healthcare has announced it is lowering the maximum daily dose instructions for Extra Strength Tylenol to six pills a day (3,000 mg) to reduce the risk of acetaminophen overdose.
The currently recommended maximum dose is eight pills a day (4,000 mg).
Today's action comes after years of consideration and actions on the federal level.
Two years ago, an FDA advisory panel recommended dropping the maximum daily dose below 4,000 mg. The panel asked for a single adult dose of 675 mg. The FDA did not follow the recommendation.
The advisory panel also recommended that the FDA place a "black box" warning on prescription medications that combine acetaminophen with another drug. These would include pain medications that combine acetaminophen with hydrocodone (Vicodin), oxycodone (Percocet), or codeine (Tylenol 3).
In January, the FDA took up the recommendation and mandated drugmakers to include no more than 325 mg of acetaminophen in each tablet or capsule of combination pain meds. That change will be phased in over three years.
And in May, the FDA said it was looking into adding dosing instructions to acetaminophen-containing medications given to children younger than 2.
Although low doses of acetaminophen are generally safe, too much of the drug can cause liver damage. Reports have indicated that acetaminophen is the leading cause of drug-induced liver injury in the U.S. One reason: People often don't realize the number of medications that contain acetaminophen, which can lead to accidental overdosing.
Over-the-counter products and prescription drugs that contain acetaminophen number in the hundreds and include Sudafed, NyQuil, Excedrin, Anacin, Midol, Theraflu, Alka-Seltzer, Percocet, and Vicodin.
McNeil, a Johnson & Johnson company, also plans to lower the maximum daily dose for Regular Strength Tylenol and other adult acetaminophen-containing products beginning in 2012.
The revised instructions for Extra Strength Tylenol will appear on packages in the fall.
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