TYLENOL'S INGREDIENT KILLS ALMOST 500 AMERICANS EVERY YEAR

Acetaminophen, Tylenol's Active Ingredient, Kills Nearly 500 Americans Every Year

 

Presently, the drug manufacturer is defending itself in federal court from at least 85 different lawsuits from consumers

 

Nearly 500 Americans die yearly from acetaminophen overdoses, with 2,600 hospitalizations and some 56,000 emergency room visits, according to a 2004 study from the University of Texas.

 

The drug is also implicated in nearly half of all cases of liver damage, researchers say. At the same time, the Tylenol brand makes more than $1 billion in revenue every year, aside from competitors.

 

Although the U.S. Food and Drug Administration (FDA) refers to acetaminophen overdose as a “persistent, important public health problem,” regulatory oversight of the drug — safe for adults, children, and infants in the right doses — has been criticized by some as too lax, compared to other developed countries from Europe to Asia.

 

U.S. regulators ruled in 2009 to require a label warning of “severe liver damage” after convening an expert panel in 1977 — 32 years later.

 

Moreover, the FDA is still finalizing safety rules for acetaminophen as part of that panel’s recommendations, nearly two generations later.

 

Upon ruling to require that warning label in 2009, regulators decided also to introduce new regulations to enhance consumer safety with regard to over-the-counter sales of the drug.

 

Those rules have yet to be implemented.

 

Rather than restricting sales of acetaminophen or requiring it to be sold over-the-counter only by pharmacies, the FDA has continued a decades-long discussion on the safety of this highly effective drug, with regard to maximum recommended daily dosage.

 

Likewise, the manufacturer has spurned efforts during the past few decades to enhance safety warnings, according to company memos and other court documents obtained through a Freedom of Information Act request by journalists.

 

Johnson & Johnson’s McNeil unit has also opposed the idea of a government information campaign to educate the public about the drug’s risk, fearing for lost sales revenue, according to investigative work by ProPublica, a non-profit corporation dedicated to public service journalism.

 

In response to queries about acetaminophen’s safety, the manufacturer issued a written statement: “McNeil takes acetaminophen overdose very seriously, which is why we have taken significant steps over the years to mitigate the risk.”

Read more - http://www.medicaldaily.com/acetaminophen-tylenols-active-ingredient-kills-nearly-500-americans-every-year-257654

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