The experts recommended that prescription drugs like Vicodin and Percocet should not contain acetaminophen. The panel cited the alarming statistic that 60% of deaths involving acetaminophen occur when taking a prescription medication. Also concerning is that acetaminophen is the leading cause of liver failure in this country. The FDA reports that 200 million prescriptions for combination drugs like these were given last year alone.
Acetaminophen is even more popularly available in over-the-counter form, in Tylenol, Excedrin, and dozens of other medications. The panel voted to lower the maximum daily dosage and the maximum single dosage for acetaminophen products available without a prescription. If their recommendation is accepted by the FDA, a single dose would be reduced from 1,000 milligrams (or two tablets) to 650 milligrams. The experts also voted to make 1,000-milligram dosages only available with a prescription.
Although acetaminophen is added to cold and cough medicines, the panel did not opt to pull those combination products from shelves. Reports show that people double up on acetaminophen while taking cough and cold formulas -- taking, for example, a Tylenol with a dose of cough medicine. However, the incidence of death in these cases is 10%, much lower than the incidence for prescription products.
The panel seemed to steer clear of the proposals to pull mass amounts of acetaminophen painkillers from the market. The experts did vote overwhelmingly, though, to add the highest level of safety label to products that will continue to be available.
I am very careful about what medication and how much I take and I give to my child. But I have to admit, I had no idea the number of unintentional overdoses and related deaths were this staggering -- simply from taking too much acetaminophen. In the haze of the flu or exhaustion of recovering from a bad cold, I am guilty of forgetting when my last dose of Tylenol was or if the doctor said it was OK to pair another painkiller with my prescription. Haven't we all been there?
As the FDA takes the panel's recommendations into consideration, I will be curious what the reaction of doctors, pharmacists, and healthcare organizations will be in the effort to address liver failure, overdosing, and drug fatalities.
Who else will listen to the panel and step up to educate consumers and patients who previously had no idea they were mishandling their medication, and taking such serious risks when they are sick?
Are you surprised by the FDA panel's recommendations and the statistics about the risks of taking too much acetaminophen?