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Johnson & Johnson said, July 28, 2011, that it's reducing the maximum daily dose of its Extra Strength Tylenol pain reliever to lower risk of accidental overdose. |
Johnson & Johnson said Thursday that it's reducing the maximum daily dose of its Extra Strength Tylenol pain reliever to lower risk of accidental overdose from acetaminophen, its active ingredient and the top cause of liver failure.
The company's McNeil Consumer Healthcare Division said the change affects Extra Strength Tylenol sold in the U.S. — one of many products in short supply in stores due to a string of recalls.
Starting sometime this fall, labels on Extra Strength Tylenol packages will now list the maximum daily dose as six pills, or a total of 3,000 milligrams, down from eight pills a day, or 4,000 milligrams. Beginning next year, McNeil will also reduce the maximum daily dose for its Regular Strength Tylenol and other adult pain relievers containing acetaminophen, the most widely used pain killer in the country.
Besides Tylenol, acetaminophen is the active ingredient in the prescription painkillers Percocet and Vicodin and in some nonprescription pain relievers, including NyQuil and some Sudafed products. It's found in thousands of medicines taken for headaches, fever, sore throats and chronic pain.
But people taking multiple medicines at once don't always realize how much acetaminophen they are ingesting, partly because prescription drug labels often list it under the abbreviation "APAP."
Two years ago, a panel of advisers to the Food and Drug Administration called for sweeping restrictions to prevent accidental fatal overdoses of acetaminophen.
"Acetaminophen is safe when used as directed," Dr. Edwin Kuffner, McNeil's head of over-the-counter medical affairs, said in a statement.
Excessive use of acetaminophen can cause liver damage. In the U.S., it's blamed for about 200 fatal overdoses and sends 56,000 people to the emergency room each year.
Extra Strength Tylenol is manufactured at a J&J factory in Las Piedras, Puerto Rico, where production has been decreased for months because the FDA, concerned about manufacturing and quality problems, is requiring additional reviews and approvals before medicines can be shipped. J&J said shipments of Extra Strength Tylenol should ramp up in the latter part of this year and throughout next year.(www.todaysgist.com)
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