Acetaminophen: Educate, Do Not Regulate

The U.S. Food and Drug Administration (FDA) is considering advice from its Advisory Committee that would eliminate all prescription acetaminophen combination medications (like Vicodin, Percocet) and take the 500 mg (extra strength) dose of acetaminophen (the medicine in Tylenol) off store shelves and make it available only by prescription. These changes could negatively affect people suffering from pain who rely on these medicines every day.  The FDA must consider all comments received by September 30, 2009 that are submitted to the official docket for this decision.  Please sign the petition letter by September 27, 2009 and the American Pain Foundation will submit the petition to the FDA.

(Submitted to docket number: FDA-2009-N-0138)

We the undersigned are expressing our concern regarding the recent recommendations of the FDA Advisory Committee reviewing the safety of acetaminophen.  When used as recommended, acetaminophen is a safe and effective pain reliever and fever reducer and has been used by millions of Americans for decades.  This medicine, like all medicines, has risks when used beyond the recommended amounts.

Three factors contribute to the mistaken overuse of this medicine: 1) The risks of over use of this medicine have not been adequately explained to the public.  Very few people know the risks associated with this commonly used medicine, 2) The labeling for this medicine is inadequate since on many medicine labels it is referred to as APAP which most people do not understand as a reference to acetaminophen.  This mis-labeling results in people not being aware that they are over-using this medicine, and  3) Acetaminophen is a second ingredient in many medicines and is often overlooked by consumers reading labels.

Before taking these medicines away, we urge the FDA: 1) to conduct a sustained public information campaign about the safe use and risks of acetaminophen and 2) improve labeling on all products that contain acetaminophen. 

Removing these medicines will negatively affect millions of people who safely use and rely on them every day.  These people will be driven to alternatives which may be less effective and have more risks. Educate, do not regulate.

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