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Extra Strength Tylenol Will Get Another Warning Label

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Beware if you are a heavy user of Extra Strength Tylenol.  You could be at risk of fatal liver failure. The FDA discovered the connection between high amounts of acetaminophen and liver damage in 1977 but it wasn’t until 2009 that it required a warning to be placed on bottles of the product. And, now with deaths increasing, Johnson & Johnson is taking another step to increase awareness about the dangers of acetaminophen.

Overdoses from acetaminophen send 55,000 to 80,000 people in the U.S. to the emergency room each year and kill at least 500, according to the Centers for Disease Control and Prevention and the Food and Drug Administration. Of the roughly 500 acetaminophen deaths reported annually, about half are accidental; the rest are thought to be suicides.  (Washington Post, 8/29/13).

Beginning in October 2013, Johnson & Johnson will place a bright red warning on the caps of Extra Strength Tylenol bottles- CONTAINS ACETAMINOPHEN, ALWAYS READ THE LABEL.  In 2011 the FDA required all prescription products containing acetaminophen to reduce the amount to 325 milligrams per pill. Tylenol was not required to reduce the amount of the ingredient in its product—500 milligrams in each extra strength tablet.

Acetaminophen is found in over 600 medicines, many of which are non-prescription pain relievers. While the FDA can alert consumers to the risks of taking Tylenol, there is the still the problem arising from the use of other medications. And, more complicated is the combined effect when a person on a painkiller takes additional medications, like a sleep aid (e.g., Nyquil) or sinus medication (e.g., Sudafed), or OTC pills to alleviate pain.  One would have to be aware of the presence of acetaminophen in each product and think about the amount consumed. The FDA considers 4000 mg per day a safe level. That’s eight Extra Strength tablets a day or less.

Johnson & Johnson, the parent company of McNeil Consumer Healthcare – which makes Tylenol –  is facing a number of lawsuits from individuals who suffered liver failure despite taking Tylenol correctly. In the Eastern District of Pennsylvania alone there are 85 cases pending.

The cases against McNeil, which share the same legal wording, allege that the company risked the lives of consumers by making “conscious decisions not to redesign, re-label, warn or inform the unsuspecting consuming public.”  (Washington Post, 8/29/13)

J&J and McNeil continue to reiterate that Tylenol is safe. “We remain confident in the safety and efficacy of Tylenol products, which rightfully have been trusted by doctors, hospitals and consumers for more than 50 years,” McNeil said in a statement.” (Washington Post, 8/29/13)

“The argument goes that if you take acetaminophen correctly you will virtually never get into trouble,” says Dr. William Lee of the UT Southwestern Medical Center, who has studied acetaminophen toxicity for four decades. “But it’s the very fact that it’s easily accessible over-the-counter in bottles of 300 pills or more that puts people in harm’s way.” (Washington Post, 8/29/13)

What is the take away from this story? Carefully read the label of every over-the-counter medication you take and call your doctor if you have any questions.

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