FDA Panel: Ban APAP and Hydrocodone
This is a game changer. If they ban the hydrocodone/APAP combinations, that will be the end of Schedule III hydrocodone. JP thinks this would be a good thing. If MDs want to run “Prescription Mills” I want their DEA recorded with each Rx. Here is the whole magilla if you want to read it.
FDA urged to ban popular painkillers
A federal advisory panel voted narrowly Tuesday to recommend sweeping safety restrictions on widely used painkillers, including reducing the maximum dose of Tylenol and eliminating prescription drugs such as Vicodin and Percocet, because of their effects on the liver.
ADELPHI, Md. — A federal advisory panel voted narrowly Tuesday to recommend sweeping safety restrictions on widely used painkillers, including reducing the maximum dose of Tylenol and eliminating prescription drugs such as Vicodin and Percocet, because of their effects on the liver.
The two drugs combine a narcotic with acetaminophen, the ingredient found in popular over-the-counter products like Tylenol and Excedrin. High doses of acetaminophen are a leading cause of liver damage.
Acetaminophen is combined with different narcotics in at least seven other prescription drugs, and all of these combination pills will be banned if the Food and Drug Administration (FDA) heeds the advice of its experts.
Vicodin and its generic equivalents alone are prescribed more than 100 million times a year in the United States.
Acetaminophen is included in a vast array of over-the-counter cough and cold products, including Nyquil, Excedrin and many others. A small share of accidental poisonings result when people take two or more of these combination products without understanding the peril.
Laureen Cassidy, a spokeswoman for Abbott Laboratories, which makes Vicodin, said, “The FDA will make a final determination, and Abbott will follow the agency’s guidance.”
The agency is not required to follow the recommendations of its advisory panels, but it usually does.
The panel’s 20-17 vote to recommend a ban on the combination prescription drugs was one of 11 it took at a meeting called to advise the FDA on problems arising from the extraordinary popularity of acetaminophen. In 2005, U.S. consumers bought 28 billion doses of products containing the ingredient.
While the medicine is effective in treating headaches and reducing fevers, even recommended doses can cause liver damage in some people. And more than 400 people die and 42,000 are hospitalized every year in the United States from overdoses.
In hopes of reducing some of these accidents, the committee voted 24-13 to recommend that the FDA reduce the highest allowed dose of acetaminophen in over-the-counter pills like Tylenol to 325 milligrams, from 500. And members voted 21-16 to reduce the maximum daily dosage to less than 4,000 milligrams.
But they voted 20-17 against limiting the number of pills allowed in each bottle, with members saying such a limit probably would have little effect and could hurt rural and poor patients. Bottles of 1,000 pills are often sold at discount chains.
“We have no data to show that people who overdose shop at Costco,” said Dr. Edward Covington, a panel member from the Cleveland Clinic Foundation.
Some doctors already avoid prescribing pills that combine acetaminophen with narcotics like oxycodone (found in Percocet) and hydrocodone (in Vicodin).
“It ties the doctor’s hands when you put the two drugs together,” said Dr. Scott Fishman, a professor of anesthesiology at the University of California, Davis, and a former president of the American Academy of Pain Medicine. “There’s no reason you can’t get the same effect by using them separately.”
He said the combinations were prescribed so often for the sake of convenience but added, “When you’re using controlled substances, you want to err on the side of safety rather than convenience.”
Still, some doctors predicted the recommendation would put extra burdens on physicians and patients.
“More people will be suffering from pain,” said Dr. Sean Mackey, chief of pain management at Stanford University Medical School. “More people will be seeing their doctors more frequently and running up health-care costs.”
In a statement, Johnson & Johnson, Tylenol’s maker, said it “strongly disagrees” with the proposed restrictions on acetaminophen, adding that they would be likely to “lead to more serious adverse events as consumers shift to other over-the-counter products,” such as ibuprofen and aspirin.
Linda Suydam, president of the Consumer Healthcare Products Association, said the committee ignored studies showing that doses sold by her members — two pills of 500 milligrams, up to four times a day — were safe.
“I think this is a very effective dose and one needed for individuals who experience chronic pain,” she said.
The committee also turned its attention to over-the-counter children’s medicines containing acetaminophen, voting 36-1 to limit them to a single formulation. Right now the liquids are sold in two different concentrations, leading to confusion among doctors and parents.
The FDA asked the committee whether it should ban combination products that include acetaminophen. The vote was 24-13 against such a ban, with many members saying consumers saw the products as valuable.
“Based on the data provided, the combination OTC [over-the-counter] medications really contributed very little to overall poisonings,” said Dr. Osemwota Omoigui, a panel member from the Los Angeles Pain Clinic.
The panel voted 36-1 to recommend that the prescribing information for such products include a boxed warning, the agency’s most urgent caution, about liver dangers.
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I hate to sound callous, but 400 people die because of APAP overdose…400. That is it, and we want to ban the most popular drugs ever? Look at drug topics list of top 200 generics…what is at the to Hydrocodon/APAP 5/500.
Cigarettes cause way more people to die and be hospitalized and we let them run around with out an Rx. What about Alcohol, it causes lots more liver damage and kills way more people, but again no Rx for that.
All our Rx bottles label “Do not take with products containing APAP” I counsel all my patients about not taking any more than 4000mg per day.
This is not rocket science people if 42000 people cannot follow along (o.o14% of our population) then let Darwinism work, survival of the fittest baby, if you cannot figure out the dosing, you should not be taking it!
You have to realize that 40% of the US are illiterate, and it comes down to if they even bother to ask their pharmacist or a simple pharmacy tech. to give them the warnings. I am more worried about the fact that there will be a “new patent” for a hydrocodone strength that people will need to cough up for pain therapy or management.
“Sorry about your $10.99 Rx is now $50+”
This is going to bode well with the public. JP did bring up the behind-the-counter idea, and it should be brought into focus for therapy management. If they want to put restrictions on APAP, then they should put it behind-the-counter (which should include Plan B, PSE, Prilosec, and some of the salicylates).
I would be OK with getting rid of the combination drugs that have more than 325mg of APAP in them. Vicodin, ES, HP, Tylox, Darvocet n-100 (crappy pain management drug anyway…), etc… I make sure to tell my patients not to take any products containing APAP with these drugs anyway, along with instructing them on the limits of tablets (not mg) per day. If they can’t pay attention to that, then let ‘em suffer the consequences. Don’t make people who truly benefit from these drugs suffer because someone else is stupid…
Yeah if they stop Vicodin and Percocet etc. What will we use for pain management. Drug manufacturers to the rescue! New! New! New! Hydroconia! Plain Hydrocodone only 15 dollars a tablet on sale now. Don’t overdose on Tylenol like 400 other Americans ask your doctor about Hydroconia now!!!
This will be a cluster frack.
Oh I forgot to add the odds of killing yourself with acetaminophen in a given year are actually less than your chance of getting hit by lightning in a given year. Next thing you know the government will be mandating that everyone buy a lightning rod for personal protection. Moronic.
When I counsel when patients are being discharged from the hospital and utilize the outpatient pharmacy before heading home, this is a no-brainer.
Numerous times I’ll tell them: “This medicine has tylenol in it. It’s best to avoid using OTC tylenol to help with your pain if you have that stuff at home, or at least call the pharmacy or your doctor before you do. Tylenol works great, but you can only take so much in a day.”
More than a handful of times, the patients had no idea that they couldn’t use both, and that’s enough for me.
Look at the bigger underlying picture…yes there are legit and serious health issues involving tylenol…but…after many decades of knowing this why now do we do this?
Let’s look at the behind the scenes here…all of a sudden the government and the media and competitors are talking down whole classes as well as specific drugs…I HOPE its over sincere concern about public health and safety but I suspect its more about insurances (which includes the government) NOT WANTING TO PAY FOR THEM ANYMORE and trying to discourage usage…
Lantus, Byetta, Chantix. Wellbutrin, Estrogens, Nsaids, Tylenol,Aspirin Psedoephedrine,Oxycontin, pediatric vaccines, pediatric cough and cold, antibiotics coumpounded formulations etc….wow lets not use these any more too dangerous…on the other hand marijauna…now that we need to use more of…???
HELLO PEOPLE! This is the stuff we make and sell and are trained to work with doctors and patienrs to ensure the therapeutic use thereof…
Note from JP. 7-3-09. No body has mentioned the TURD IN THE PUNCHBOWL, Everybody sees it, but nobody says anything about it. Do you honestly believe that hydrocodone/APAP is the most popular drug dispensed because of the Rxs for legitimate pain? Give me a break. Look at the Rxs for 240 tabs or 180 tabs and then look
out front at the “patient”.
My call is that, AT LEAST, every other one is a drug seeker.
I know, cash money. For many of you that turd could be on your head, but “Shit, Jay Pee,
I gotta pay for my daughter’s ballet lessons, my son’s football camp and my spouse’s golf lessons. Anyways, how do you know that there are that many drug seekers? Mister Smarty Pants Jay Pee.”
Texas now requires the doctor’s state narcotic license (DPS #) to be sent to DPS monthly with data on any and all Controlled Substance Rxs. They must have shared data with the feds because Dr.s Mister and Mrs. Sharma (South Houston) are in federal custody as I write this. The DEA found $1.6 million in $20 dollar bills.
I think that, maybe, the misuse of this combo may be one reason to get rid of it. Let them write hydrocodone plain, Schedule II. I know. No refills. Fuck ‘em. Pain management means seeing your patient often. Write new triplicates.
This is all thanks to “yes we can.”
Yes we can dwindle the drug supply to 5 or 6 drugs. Yes we can have the dea punish pharmacists/doctors for not dotting heir i’s and crossing their t’s. Yes we can have a single payor system. Yes we can have only on company run 6 or 7 mail order pharmacies nationwide and close the rest.
Blame David Monroe Stanley (aka Drug Nazi/monkey) of Monterrey, CA for some of this.
I’m sorry Wally but I don’t really see how the things you comment on fit together. The drug monkey is a liberal so he must hate tylenol. How does that work? Random. I can understand the anger at unnecessary rules and laws to protect 400 people but maybe you should be angry at the FDA. Plus I’m still not sure how you make the jump from tylenol being outlawed to single payor healthcare.
As for prescription mills…fyi unless the fbi/dea has an active investigation going on the qt and are looking for bigger fish, they and insurance companies love to get heads up about rogue doctors and pharmacies…I mean really when a doctor sits in yout lobby in the middle of the city handing out dozens of blank prescription forms to people cause he’s out of business cards you really need to do somehting…BTW I hear eventually said Dr., upon hearing his sentence was 280 months, calculated the years on his fingers and promptly passed out cold…
I can only imagine the gigantic mess that will fall on pharmacists if these meds are actually pulled off the market. I remember about 7 or 8 years ago when Percocet started to come in different strengths besides the standard 5/325 the amount of education that was involved for local physicians and the number of scripts that I had to turn away. “What do you mean, there’s more than one strength of Percocet? Since WHEN?? Fine, just write the strength in on the prescription. Wait, what do you mean you can’t take that over the phone? I have to rewrite the prescription?? This is bullshit!” At the time, the law in the state I practiced in was that nothing on a CII rx could be added or changed. Within a year or so, the rules were loosened up to allow a pharmacist to clarify the dose, directions, and date written with the prescriber.
I can imagine the responses if we tell people that hydrocodone products are no longer available…
Why DOES the FDA suddenly care about tylenol? Are they tired of denying medication to my hospice patient by trying to remove concentrated morphine 20mg/ml solution from the market?
From: JP 7-9-09. Look closely, Pharmer Jane. The FDA of the last decade or so didn’t care about much. Six months into the NEW FDA and they’ve got tobacco, a panel suggested lowering age limits on Plan-B, now a generic Plan-B has been approved. I agree that aiming at “Tylenol” is a huge bite. Can the FDA chew it?”
Bluetowelboy,
What are you talking about? I totally hate Tylenol. Tylenol is a tool of the elitist, capitalist, ruling class to oppress the honest working people of the world.
Not really. I just decided to use the considerable influence my blogspot account gives me with the FDA against the world’s most popular pain reliever for no other reason than to stop the easing of your pain. Because I’m evil and scary.
I’m going after ibuprofen next.
Fear me.