A U.S. Food and Drug Administration advisory panel has urged a ban on the popular prescription painkillers Vicodin and Percocet, which combine acetaminophen with an opiate narcotic, and the lowering of the maximum dose of over-the-counter painkillers with acetaminophen, like Tylenol or Excedrin.
The panel’s recommendations followed the release of an FDA report last month that found severe liver damage, and even death, can result from a lack of consumer awareness that acetaminophen — which is easier on the stomach than such painkillers as aspirin and ibuprofen — can cause such injury.
The dangers from use or abuse of Vicodin and Percocet may be even more concerning, one key panelist said.
“It seems to me that problems with opiate combinations are clearly more prevalent,” Dr. Lewis S. Nelson, chairman of the FDA’s Drug Safety and Risk Management Advisory Committee, said during a Tuesday press conference held after the two-day meeting.
Explaining the panel’s 20-17 vote to ban prescription acetaminophen/opiate drugs, Nelson said, “There are many deaths that relate to problems with prescription opiate combination acetaminophen products, whereas the number of deaths clearly related to the over-the-counter products are much more limited.”
But the FDA advisers also took aim at over-the-counter (OTC) acetaminophen products. The agency’s report found that many people may consume more than the recommended dose of these pain relievers in the mistaken belief that taking more will prove more effective against pain without posing health risks. Consumers may also not know that acetaminophen is present in many over-the-counter products, including remedies for colds, headaches and fevers, making it possible to exceed the recommended acetaminophen dose, the report said.
Based on that, the FDA advisory panel voted 21-16 to lower the maximum daily dose of nonprescription acetaminophen, which is currently 4 grams — equal to eight pills of a drug such as Extra Strength Tylenol. The panel was not asked to recommend another maximum daily dose.
The panel also voted 24-13 to limit the maximum single dose of acetaminophen to 650 milligrams. The current single dose of Extra Strength Tylenol, for instance, is 1,000 milligrams.
The panel also voted 26-11 to make the 1,000-milligram dose of acetaminophen available only by prescription.
The advisers voted against other safety restrictions for other over-the-counter drugs such as NyQuil or Theraflu, which contain acetaminophen and other ingredients that treat cough and runny nose. Patients often mix the cold medications with pure acetaminophen drugs, like Tylenol, leaving them vulnerable to dangerously high levels of acetaminophen.
The FDA is not obligated to follow the recommendations of its advisory panels, but it typically does so.
6 comments Add your comment
Pat Cooper
July 8th, 2009
1:23 pm
Can we think about this for a second? I mean, logically. Do the members of the FDA understand what it is to live with chronic pain? Aching, constant pain that zooms up and down a pain chart with the regularity of the contractions of birth? What do they suggest we who depend on acetaminophen, Vicodan or Percocet do if they decide it’s in our best interest for these items to have their approvals revoked? I’m allergic to aspirin–not an upset stomach ‘allergic’ but trouble breathing and hives ‘allergic’- and acetaminophen is my drug of choice for the usual aches and pains. I also have fibromyalgia, and along with the appropriate medication, I rely, alternately, on Vicodan or Ultram. My doctor watches me, checks me and uses his medical knowledge to dispense the appropriate doses. If I’m under my doctor’s care, why does the FDA (a somewhat bizarre government agency who doesn’t seem to follow through on much of anything anyway) think they’re entitled to take my only relief off the market? Apparently, the liver damage they’re worried about is only a result of abuse. Trust us who suffer from chronic pain, our doctors are so afraid of turning us into prescription junkies, that we’re practically begging for pain medication. At least with acetaminophen or Vicodan, I have a chance for some relief and the opportunity to lead a more normal life as a result. Let the FDA place warnings on bottles (as they do on cigarettes) and let us grown ups decide how to run our own lives. Alcohol and tobacco cause far more damage than these pain medications and, so far, nobody has made them illegal.
skyblu5555
July 10th, 2009
12:48 am
First give each FDA member two hip replacements. Then ask them whether percocet and vicodin should be removed from the market due to acetaminophen concerns…what morons…will fentanaly patches, oxycotin, and morphine now replace percocet and vicodin for chronic pain sufferers? Nothing like having no clue about those who suffer from chronic pain and being able to function and work vs being bed ridden…. walk in our shoes first, please.
20yearCancerSurvivor
July 22nd, 2009
12:01 pm
20 years ago I received old school radiation. In other words… A boat load. The long term side effects include: neuropathy from spinal stenosis, pulmonary fibrosis, post herpetic neurogia… Vicodin has provided me with a quality of life that has helped me survive all these years. Removing this access would greatly decrease my chances of continuing my survival. Many of us that are users of these meds are not abusers. I guess, if you want to quickly euthanize a large group of people, this would certainly work… REMOVE THEM FROM THEIR SURVIVAL MECHANISM.
Ryan
July 23rd, 2009
6:20 pm
Here we go, once again the federal government has decided to outlaw pain medications that have been improving the quality of cronic pain suffers lives. This countries quality of healthcare is going to s**t. What next processed foods? All the crap they use to preserve foods is far more dangerous that Vicoden or Percocet. I guess I should move to California and become a pothead. Better yet maybe its time to move to another country, its seems to me that the land of the free are no longer free. Let the people who have to deal with these issues decide what’s best for them and focus more on illegal drugs. Take my money, take our freedoms, and now you want to take my relief. Wow you just got to love America.
TERI
January 29th, 2010
3:00 pm
Try telling all these people who dont live with pain that question….. sound stupid huh… Try telling people that cant get out of bed because of such bad fibro or arthritis or back surgery… think before you type ..or maybe your mother, grandma, sister has some disease that has to live with pain all day. Think about it stupid..
Dawn
February 7th, 2010
3:42 pm
My life has been destroyed due to my spouses addiction to percocet these doctors hand out these prescription drugs to freely and they get into the hands of people who sell them right out of their convienence store, literally, that’s where my husband buys his right across from a grammar school.
I’ve reported it numerous times, no one cares.