How much is too much?
A federal advisory panel’s vote Tuesday to pull two popular prescription drugs off the market has shed light on a problem with a common ingredient in over-the-counter painkillers: acetaminophen.
The Food and Drug Administration panel recommends banning drugs like Vicodin and Percocet which combine a stronger narcotic with acetaminophen – the key ingredient in medicine cabinet staples like Tylenol and Excedrin. (It’s unclear if will happen, though. The FDA isn’t required to follow the panel’s advice, but it often does).
The reason for the recommendation? Big concerns about overdoses related to acetaminophen. A New York Times story explains not only can the painkiller cause liver damage, more than 400 people die and 42,000 are hospitalized every year in the United States from overdoses.
In an effort to confront such problems, the panel made a slew of other decisions about the painkiller. Experts voted to lower the maximum daily dosage to less than 4 grams, or eight tablets of Extra Strength Tylenol. Another vote recommended a prescription for a 1,000 milligram dose – or two tablets of Extra Strength Tylenol.
Although the drug has been on the market for half a century and is used by millions to treat fevers and headache, excessive use is a longstanding problem, said the FDA and other experts.
Still, much of the public isn’t aware of the potential harms of the painkiller, said Lynette Bradley-Baker, an assistant professor at the University of Maryland’s School of Pharmacy, who attended the hearings Monday.
And many others don’t know which products actually contain acetaminophen and how much. Most cold and flu medicines use the ingredient in combination with others, but how many of us check the back of medicine labels before we buy?
So how much is too much? That’s unclear. Bradley-Baker said she hopes the FDA will look at research into the true safe dose of acetaminophen.
“Having some constraints in place is a good start,” Bradley-Baker said. For now, she also hopes that the panel’s advice will spark discussion among patients, doctors and pharmacists about the painkiller’s safety.
Comments
Where has the FDA been all these years? there is a related post at http://iamsoannoyed.com/?p=2017
Posted by: carly | July 2, 2009 6:21 AM
The company that makes 'Tylenol' is big and has always known the hazards of acetaminophen overdoses and it's affect on the liver. They cornered the market for years until other companies were able to sell it in it's generic form. So now the FDA thinks this is big news??
Posted by: Carolyn Edwards | July 2, 2009 11:01 AM
as a primary care physician I share the concern about tylenol prescribing. However, it remains an important, and generally safe, analgesic--espcially in elders. One of our jobs as health professionals is to take accurate histories from our patients--including all medications--and to educate them to the possible hazards of "hidden" acetominephen(eg., percocet, nyquil,etc.)
Posted by: bx doc | July 2, 2009 2:59 PM
The FDA Meeting Issue Background Document is at:
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/UCM164897.pdf
Options 1(a) and 1(b) propose limitation of acetaminophen to 325mg per dose for OTC sales (and possible inclusion of all prescription formulations).
Option 5(b) proposes eliminating all prescription medications complexed with acetaminophen.
What is not (directly) stated by the FDA is the single most significant factor at play. Hydrocodone (Vicodin, Lortab) complexed with acetaminophen is a Schedule III medication. Hydrocodone (alone) is under Schedule II. And there currently is NO SUCH PRODUCT manufactured!
Thus, the FDA [if they choose to vote for Option 5(b)] will (effectively) "re-schedule" hydrocodone from Schedule III to the *much* more restrictive Schedule II (written prescriptions only, maximum 30-day supply, etc.).
Addressing the current non-existence of any hydrocodone (only) product, the FDA Background Document (lazily) states:
“For development of hydrocodone single-agent formulations, implementation would include:"
... "Submission of NDAs and ANDAs for single-ingredient hydrocodone products, which may also require clinical studies for demonstration of efficacy.”
A reported 460,000 prescriptions for hydrocodone with acetaminophen are written and filled every business day in the United States. (Despite) the fact that the public comment window has passed, all affected patients, physicians, and institutions would be wise to protest - loudly.
Posted by: Pithius | July 15, 2009 12:55 AM