FDA Advisers Urge Smaller Doses of Acetaminophen

"The 1,000 milligram pill should never be at the patient's discretion. It should only be prescribed by a physician," Teperman said. "If you took an entire bottle of Tylenol Extra Strength, three days later you would be in a coma and needing a liver transplant."

The Associated Press: FDA panel to vote on painkiller restrictions

Despite years of educational campaigns and other federal actions, acetaminophen remains the leading cause of liver failure in the U.S., sending 56,000 people to the emergency room annually, according to the FDA. There are about 200 acetaminophen-related deaths each year.

"It can happen to anybody, but it's very rare," said Dr. Lee Simon, an associate professor at Harvard Medical School, who attended Monday's meeting. "Obviously it's important that we improve the communication about these products because they are ubiquitous, and we still see people inadvertently overdosing."

But wait, there's more!

The numbers the AP parrots are for total deaths and injuries, including deliberate overdoses.

According to the FDA's report, the figures it is relying on are from the Consumer Product Safety Commission's National Electronic Injury Surveillance System in the year 2000 and the Center for Disease Control's National Hospital Ambulatory Medical Care Survey taken from 1993 to 1999.

So, the data the FDA uses (and passes out to news organizations) seems to be at least nine years old.

How this data reflects the impact of the FDA's awareness campaign concerning the "dangers" of acetaminophen "and other federal actions" is unknown. Was any campaign even in effect during the years the data is taken from?

Also, when intentional overdoses are removed from the data (according to the data used by the FDA and the AP), the number of deaths drop from 460 to 100, hospitalizations drop  from 26,000 to 2,100 and hospital visits drop from 56, 700 to 13,000.

Keep in mind that there are about 280,000,000 people in this country.

Out of that number, 100 unintentionally overdose and die on acetaminophen each year.

For a comparison, in 2003, 17,229 people in the US died from falling.

I really don't think we need the FDA to save us from acetaminophen.