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Tylenol, Sudafed, NyQuil, Excedrin and Vicodin - Are they safe?

Jim

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Low doses of acetaminophen are generally safe, but 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. Over-the-counter products and prescription drugs that contain acetaminophen number in the hundreds include well known popular products like; Sudafed, NyQuil, Excedrin, Anacin, Midol, Theraflu, Alka-Seltzer, Percocet, and Vicodin. So it is interesting that 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.

Two years ago, an FDA advisory panel recommended dropping the maximum daily dose to below 4,000 mg. The panel asked for a single adult dose of just 675 mg. The FDA did not follow that recommendation.

The advisory panel also recommended that the FDA placed 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 pharmaceutical manufacturers to include no more than 325 mg of acetaminophen in each tablet or capsule of combination pain medications. But that change will be phased in over three years,presumably to allow time for the pharmaceutical manufacturers to accommodate these new limitations. Low doses of acetaminophen are generally safe, but too much of the drug can cause liver damage. So why allow 3 years for this to be introduced? If the drugs represent a danger then these changes should surely be enforced now. Even though reports have indicated that acetaminophen is the leading cause of drug-induced liver injury in the U.S. over-the-counter products and prescription drugs that contain acetaminophen number in the hundreds and include well know products such as Sudafed, NyQuil, Excedrin, Anacin, Midol, Theraflu, Alka-Seltzer, Percocet, and Vicodin. Is the FDA protecting these brands and their sales whilst putting the public at risk?

At least McNeil, a Johnson & Johnson company, apparently plans to lower the maximum daily dose for Regular Strength Tylenol and other adult acetaminophen-containing products beginning in 2012.

 


   
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