Existing users please login

 

Home / Markets

Panel Urges FDA to Tighten Tylenol Dosage Standards

 
By Ken Sweet
FOXBusiness
     

    A panel that advises the Food and Drug Administration voted Tuesday to recommend reducing the maximum daily dosage of Johnson & Johnson’s (JNJ) widely-popular painkiller Tylenol, saying the current dosing poses a risk of fatal liver damage to consumers.

    The recommendation applied to all drugs containing acetaminophen, which is the generic name for Tylenol and Excedrin, along with liquid cold/flu medications like NyQuil and Theraflu.

    In Maryland, the advising panel voted 24-13 to recommend that a single adult dose be reduced to 650 milligrams from 1,000 milligrams. Further, Tylenol’s 500-milligram, “extra-strength” dose should be available by prescription only.

    The current dosing instructions for Johnson & Johnson’s Extra Strength Tylenol say that adults should take two 500-mg tablets every 4 to 6 hours, or no more than eight tablets per day.

    If the measures were adopted by the FDA, the maximum daily dose of acetaminophen would be reduced from 4 grams a day to new unspecified dosage.

    The dangers of acetaminophen, one of the most popular painkillers in the world with an estimated 28 billion doses administered in 2005, has been widely known for many years. Warning labels, including the one found on bottles of Tylenol, but still an estimated 100 patients a year die from an acetaminophen overdose, according to the FDA.

    While the amount of people dying from acetaminophen is minimal compared to the FDA's 2005 dosing figures, the panel’s vote is an indication that the FDA wants to minimize the risk of taking such a ubiquitous medication like Tylenol at those concentrations. However because it’s an over-the-counter drug, there is no way to enforce medication dosing.

    Officials at the FDA said that the panel's recommendation reflects a failure to adequately educate consumers about the consequences of overdosing on Tylenol. 

    "We looked at the results of the educational campaign and it wasn’t going the way we wanted it to go," said Dr. Gerald Dal Pan with the FDA's Office of Surveillance and Epidemiology.

    Shares of Johnson & Johnson were down 1.2% in Tuesday trading, at a similar pace as the rest of the broader market.

    In a separate vote, the FDA panel said that large-sized packaging should remain for acetaminophen, saying that smaller products may pose a risk to seniors who cannot make multiple trips to a store. 

    The panel also narrow voted to eliminate prescription acetaminophen combination products like Vicodin and Percocet, which combine acetaminophen with a higher-strength narcotic. Vicodin is marketed by Abbott Laboratories (ABT), while Percocet is marketed by Endo Pharmaceuticals (ENDP), but both are available in generic equivelants

    Despite the pane's vote to change the labels, FDA officials said the most important thing consumers can do is follow a manufacturer's directions regarding any medication they are taking.

    "Read the labels and know how these medications may interact with your other mediations," said Dr. Sandra Kweder.

     
    null