FDA looks for ways to reduce dangerous overdoses of Tylenol

By Johan73 · Jun 29, 2009 · ·
  1. Johan73
    Millions of Americans take Tylenol, Excedrin and other pain relievers containing acetaminophen. And they never think of them as anything but safe. But the Food and Drug Administration is in the middle of 2 days of hearings focusing on a dangerous side effect of the medications, severe liver damage.

    The govenment says overdoses of acetaminophen send an estimated 56,000 people to the emergency room every year. It's the leading cause of liver failure in the U.S.

    The makers of medications with the ingredient are trying to dissuade regulators from placing new restrictions on the drugs -- and possibly even removing some of them from the shelves.

    The FDA is asking experts for new ideas on reducing accidental overdoses of Tylenol and other over-the-counter pain relievers. Two options are adding a "black box" warning label to the products and lowering the doses of some of the drugs.

    Associated Press - June 29, 2009 1:23 PM ET

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  1. chillinwill
    It's about time that they start to recognize the dangers of acetaminophen. Now if only they would realize that this can be much more dangerous than say marijuana
  2. trptamene
    You guys this is HUGE!!!!

    This means things like vicoden and vicoden may be taken off the market and almost all acetaminophen may be removed as a substance that can be compounded with prescription drugs. Let's hope so.

    I hope to god they wise up and realize allowing 10mg and 5mg oxycodone IR pills w/o NSAID's is TONS safer than all this tylenol which as almost all DF users know is horrible for ppl.
  3. Johan73
    Tylenol-Containing Cold Drugs Can Stay, Panel Says

    [IMGL=WHITE]http://www.drugs-forum.com/forum/attachment.php?attachmentid=9439&stc=1&d=1246393218[/IMGL]Over-the-counter cold and pain medicines that combine the painkiller acetaminophen with other drugs shouldn’t be removed from U.S. store shelves because of the risk of liver injury, a panel recommended.

    Outside advisers to the Food and Drug Administration voted 24-13 today against limiting Johnson & Johnson’s Tylenol and generic nonprescription acetaminophen to single-ingredient products.

    Over-the-counter drugs that combine the painkiller with decongestants, aspirin, caffeine or other medicines represent about half of all acetaminophen sales, according to the FDA. These products include Tylenol Cold, Bayer AG’s Midol and Novartis AG’s Excedrin.

    Acetaminophen has been a leading cause of liver injury for more than a decade, even with efforts to educate users about the danger of taking too much, the FDA says. The panel, meeting in Adelphi, Maryland, earlier voted that the daily maximum dose of Tylenol and other over-the-counter medicines containing acetaminophen should be reduced and Extra-Strength versions should be sold by prescription only.

    June 30, 2009 14:23 EDT
    To contact the reporter on this story: Catherine Larkin in Washington at [noparse][email protected][/noparse]
  4. Johan73
    Tylenol and the liver

    The Food and Drug Administration's advisory panel has recommended that the agency reduce the maximum recommended dosage of acetaminophen, an over-the-counter pain killer more commonly known as Tylenol. The drug's potential risk of liver damage is the issue.

    Here's the Associated Press story.

    And, for a fuller explainer, here's this from MedicineNet: "How is acetaminophen processed (metabolized) in the body?"

    "The liver is the primary site in the body where acetaminophen is metabolized. In the liver, acetaminophen first undergoes sulphation (binding to a sulphate molecule) and glucuronidation (binding to a glucuronide molecule) before being eliminated from the body by the liver. The parent compound, acetaminophen, and its sulphate and glucuronide compounds (metabolites) are themselves actually not harmful. An excessive amount of acetaminophen in the liver, however, can overwhelm (saturate) the sulphation and glucuronidation pathways. When this happens, the acetaminophen is processed through another pathway, the cytochrome P-450 system. From acetaminophen, the P-450 system forms an intermediate metabolite referred to as NAPQI, which turns out to be a toxic compound. Ordinarily, however, this toxic metabolite is rendered harmless (detoxified) by another pathway, the glutathione system."

    If that's more than you want to know, there's always this from the FDA: "Acetaminophen and liver injury: Q & A for consumers."

    It begins: "Acetaminophen is the generic name of a drug found in many common brand name OTC products such as Tylenol, as well as prescription products such as Vicodin and Percocet."

    Most people, of course, don't take the more tightly controlled Vicodin and Percocet like candy -- as they sometimes do Tylenol.

    -- Tami Dennis
    10:23 AM, June 30, 2009
  5. cra$h
    ah, only if this happened a couple years ago... Swim would be eternally blessed the day CWE's are eliminated, and thousands of lives are spared this senseless liver damage. Most people are still convinced that opiates are much more harmful that fucking APAP.....
  6. chibi curmudgeon
    What probably contributes to this more than anything is the use of brand names and brand-oriented packaging, i.e., you see in the photo "PAIN RELIEF" on the bottle, rather than "ACETAMINOPHEN." They seem to have gotten better about specifying what's in some of these OTCs, but in others I still find myself looking on the back for the fine print listing exactly what's in it. Patients see "Tylenol" and "Excedrin" and "Walgreens Brand Pain Reliever" and think they're different drugs. If I tell a patient not to take acetaminophen with their Lortab, they might not know what I'm talking about, or think "nope, the stuff I have at home is called Tylenol." Or think that a "cough and cold" OTC is different from a menstrual cramps OTC, so they can be taken together. If it were more obvious what's in these things, patients might not make these mistakes as easily.

    Basically, people are fucking stupid and we have to dumb shit down so they don't kill themselves. :(
  7. Venusia
    I'd be nice if we could get hydrocodone as a stand alone drug rather than only with APAP/IBU/ASA. Swiv has asked her doctor for a script for just hydrocodone, which can be sold alone if compounded per the doc's scrip, but he told Swiv that her insurance would not cover it. If they'd stop putting so much damned APAP in all these pain pills, people would suffer less liver damage. Let's hope they figure that one out.
  8. drug-bot
    they already make a hydrocodone/iburprofen pill called Vicoprofen. swim got some that were 7.5/200mg, dont know what other strengths they may come in.

    if they did take vicodin off the market becase it has acetaminophen and sold plain hydrocone pills it would be placed in schedual 2 instead of schedual 3 like it already is, only opiates with an added otc painkiller are in schedual 3, and doctors are always more cautious when dispensing schedual 2 meds, because the dea cares alot more about those, and no doc likes dealing w/ those fucks.
  9. Venusia

    Yeah, Swiv believes the 7.5 strength is the only one vicoprofen comes in. She's trying to get her surgeon to script it to her for her post-op swelling and pain. He gave her oxycodone last time, so she hopes he'll just give her the less strong, anti-inflammitory containing drug instead of just oxy again, if anything at all.

    SWIBot is right. It would be a CII instead of a CIII, which would suck. Swiv forgot about that. Why do law-enforcement officers think they can make medical decisions? Swiv will never understand why that is the way it is. :thumbsdown:

    Aaaanyway, back on topic: How about scripting stuff with ASA or the IBU instead of just defaulting to APAP? Seems as though docs just are on auto-pilot or just like to write for Vicodin/Lortab rather than consider that the patient may benefit more from an NSAID than APAP, which only has analgesic and antipyretic properties. Do they even think when they whip out that Rx pad?
  10. fuzelogic
    SWIM remembers when they made ephederine products require signature and a whole lot of hoops for a runny nose. :applause: How much has that stopped the flow of Meth?:laugh:

    Seems like another way to require a signature / annoyance for the common person who uses the product.

    SWIM agrees it would be good to remove the chemicals that cause liver failure especially for people who take it for extended periods of time for pain management. Not only do you get to have a pain problem, but heck why not have problems with the liver and stomach from long-term exposure to the APAP.

    At SWIDrugBot, SWIM hopes SWIY is wrong, but SWIM thinks SWIY is right on the point.
  11. chillinwill
    Panel Recommends Ban on 2 Popular Painkillers

    ADELPHI, Md. — A federal advisory panel voted narrowly on Tuesday to recommend a ban on Percocet and Vicodin, two of the most popular prescription painkillers in the world, 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, and the panel noted that patients who take Percocet and Vicodin for long periods often need higher and higher doses to achieve the same effect.

    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 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.

    Laureen Cassidy, a spokeswoman for Abbott Laboratories, which makes Vicodin, said, “The F.D.A. 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 drugs was one of 11 it took at a meeting called to advise the F.D.A. on problems arising from the extraordinary popularity of acetaminophen. In 2005, American 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 to 13, to recommend that the F.D.A. reduce the highest-allowed dose of acetaminophen in over-the-counter pills like Tylenol to 325 milligrams, from 500. And members voted, 21 to 16, to reduce the maximum daily dosage to less than 4,000 milligrams.

    But they voted, 20 to 17, against limiting the number of pills allowed in each bottle, with members saying such a limit would probably 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.

    Dr. Lewis S. Nelson, a toxicologist from the New York University School of Medicine who served as the panel’s acting chairman, said experts had been warning of the dangers of combination painkillers like Percocet and Vicodin for years.

    Still, the recommendation is likely to come as a shock to many patients, who may be unaware of the dangers of high doses of acetaminophen — even if they know the drugs contain the ingredient.

    Some doctors already avoid prescribing the combination painkillers.

    “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.

    While the panel offered an array of sometimes conflicting advice, Dr. Sandra Kweder, deputy director of the agency’s new drug office, said one message about acetaminophen in both over-the-counter and prescription medicines was clear: “The usual dose people take probably ought to be lowered in order to ensure a greater margin of safety.”

    Johnson & Johnson, Tylenol’s maker, released a statement saying it “strongly disagrees with the committee’s recommendation,” which would likely “lead to more serious adverse events as consumers shift to other over-the-counter products” like Advil and aspirin.

    Linda A. Suydam, president of the Consumer Healthcare Products Association, said the committee ignored studies showing doses sold by her members — two pills of 500 milligram each 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,” Ms. Suydam said.

    The committee was concerned that manufacturers presently sell two different strengths of pediatric liquid formulations, leading to confusion among doctors and parents.

    “I don’t think it’s safe to have two formulations out there,” said Dr. Nelson, the panel’s acting chairman.

    The committee voted, 36 to 1, to limit to a single formulation the liquid pediatric over-the-counter acetaminophen products, although they were divided over whether the industry should pick the concentrated or less-concentrated formula. F.D.A. officials suggested that they would likely settle on the less-concentrated formula so that if parents make a mistake, they would be less likely to overdose.

    “We believe there is some justification for why you have two different doses,” Ms. Suydam said in response. But she acknowledged that the committee strongly urged the F.D.A. to force the industry to settle on a single liquid formulation. “We will take that into consideration and work with the F.D.A.,” she said.

    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 results from people who take two or more of these combination products simultaneously without understanding the peril.

    The F.D.A. asked the committee whether it should ban combination products from including acetaminophen. The committee voted, 24 to 13, against banning such products, with many members saying that consumers saw the products as valuable.

    “Based on the data provided, the combination O.T.C. medications really contributed very little to overall poisonings,” said Dr. Osemwota A. Omoigui, a panel member from the Los Angeles Pain Clinic.

    A 2005 study found that the majority of poisonings resulted from patients taking Vicodin and similar products that combine a narcotic with acetaminophen.

    “I think this is the one place where we can engineer in safety,” said Dr. Judith M. Kramer, a panel member and an associate professor of medicine from Duke University Medical Center who voted to ban the combination prescription medicines. “We’re here because there are inadvertent overdoses that are fatal, and this is our one opportunity to have a big impact.”

    Even if F.D.A. allowed such products to be sold, many panel members suggested that the dose of acetaminophen be lowered. And the panel voted, 36 to 1, that the prescribing information for such products include a boxed warning, the agency’s most urgent caution, about liver dangers.

    Consumers need to be better educated about the risks of popular medicines, most panel members agreed.

    “If you keep track of what you’re taking, none of this is an issue for you,” Dr. Jan Engle, a panel member and head of the Department of Pharmacy Practice at the University of Illinois in Chicago, said in an interview after the meeting.

    Published: June 30, 2009
    NY Times
  12. RaverHippie
    ^^ that was a good article, was just coming to post it.

    I will run around in circles and do a happy dance if regulatory forces could possibly overpower the industry's lobbying forces to ban vicodin and perocet with acetaminophen. The statement from the representative echoes the sentiment well. "Take 500mg of acetaminophen for chronic pain relief" yeah... right.
  13. Johan73
    Life Without Vicodin Will Be OK, Doctors Say

    Some Patients Worry Over Possible FDA Ban on Drugs like Vicodin

    [IMGR=white]http://www.drugs-forum.com/forum/attachment.php?attachmentid=9458&stc=1&d=1246554103[/IMGR]For 22-year-old Jacob Rosenberg, life without his daily dose of Vicodin wouldn't be much of a life at all. "Before I began taking narcotics two years ago, I would spend my days in bed," said Rosenberg, who has suffered from fibromyalgia and rheumatoid arthritis for five years, and chronic pain for 10. "I was in college and I wasn't capable of doing anything – go to classes or go out."

    "But since I've been on Vicodin my pain is 80 percent diminished," said Rosenberg. "It gives me the ability to be a normal person."

    Rosenberg is one of millions of Americans who fill prescriptions each year for an acetaminophen-based narcotic – or combination drugs – such as Vicodin or Percocet, the two most popularly prescribed drugs in the country.

    But patients like Rosenberg are worried that the solution to their pain may soon be unavailable to them after an expert advisory panel for the U.S. Food and Drug Administration voted earlier this week to ban combination drugs.

    The panel's vote came after days of deliberation over ways to reduce the liver damage risk associated with acetaminophens. The panel also voted to keep over-the-counter combination pills containing acetaminophen on the shelves and lower the maximum dosage of these pills.

    The panel voted 36 to 1 to recommend a "black box" warning for prescription medications that combine acetaminophen with another drug.

    "It's completely unfair to take these drugs away from us," said Rosenberg. "Without them you can't act like a normal person."

    Experts Say Hope Is Not Lost Without Combination Drugs
    But medical professionals disagree, and say that those suffering from chronic pain will not be left without medication should the FDA decide to heed the advice of the panel.

    "There are a lot more drugs out there than are being used," said Dr. Charles Kim, a pain management specialist at Mount Sinai School of Medicine in New York.

    "I would tell patients who are panicking over [this vote] to relax, it doesn't mean they're going to take pain medication off the market completely but just that they're thinking about changing certain prescribing patterns to increase safety," said Kim.

    More FDA regulation on prescription combination agents as well as more labeling of over-the-counter acetaminophens could help reduce the number of unintended overdoses, according to Dr. Eugene Viscusi, the director of pain management at Thomas Jefferson University in Philadelphia.

    Because nearly 42,000 people visit emergency departments each year with acetaminophen overdoses, half of which are accidental, eliminating drugs that aren't clearly labeled to have acetaminophen in them could decrease this number significantly, said Viscusi.

    "The problem is not just with prescription narcotics," said Viscusi, "It's their use in combination with over-the-counter drugs."

    Eliminating combination drugs would result in patients being able to treat their pain with two different pills, rather than just one. While some may see this as an inconvenience, Viscusi said he's hopeful it might lead to increased awareness about what patients are actually ingesting.

    "This would be the best thing," said Viscusi. "If you're taking the acetaminophen separately from your opioid then you know exactly what you're taking."

    And as for patients who say nothing else will ease their pain but the acetaminophen-based narcotics, Viscusi says there are other drugs that can help them.

    "There will be other drugs, it just may require a little adjustment in thinking for those doctors who consistently prescribe Vicodin and Percocet," said Viscusi.

    Other Drug Alternatives
    Percocet, for example, could be given to patients by prescribing them Oxycodone – which does not include acetaminophen – and then instructing the consumer to take Tylenol as well.

    Still, Viscusi is advocating for better labeling on over-the-counter drugs in addition the ban of combination agents as well as more education for consumers and medical professionals alike.

    Kim agrees with Viscusi and said that with more training and education, doctors will realize the Vicodin and Percocet are not the only options for pain management.

    "Many doctors don't readily have the experience or knowledge of prescribing other agents that either reduce the amount of acetaminophen or take it out completely, such as Norco, Roxicodone, OxyIR, OxyFast or hydromorphone," said Kim.

    "These can be safely and effectively used on patients with quality of life-dependent needs who many not be candidates for the acetaminophen, yet need the adequate pain relief to function in their daily lives," he added.

    But those who would likely be directly affected by an FDA ban on combination drugs – patients of chronic pain – are still worried.

    "This will hurt a huge amount of people who look to those medications to help manage the pain so they can be a productive part of society," said Penney Cowan, the executive director of The American Chronic Pain Association, who has been suffering from chronic pain herself for more than 30 years.

    "It will narrow the field even more when it comes to treatment for pain," said Cowan. "There is going to be a point where there just won't be any other options."

    "The problem with pain is that we don't see it, and we can't measure it," said Cowan. "People don't understand just how much pain we are in."

    July 2, 2009, ABC News, By EMILY FRIEDMAN
  14. RaverHippie
    That last one is just fearmongering done by industry groups. They tell people "The government is going to take away your painkillers and you will be left with nothing. This is just ongoing to reduce the amount of acetaminophen in circulation NOT painkillers in general. This is like a "local news report at 11pm" interviewing people on the street that are hurt so that eh audience feels sympathy and sides with Pharma.

    Ridiculous journalism.
  15. cra$h
    dumbass journalism if you ask me. they're supposed to get the story, not their side. The biased of the media and the constant bombardment of "shocking stories" has me not trusting anything on TV, which is increadibly sad considering how useful that tool can be.
  16. Greenport
    I like the 'black box' warning idea regarding acetaminophen overdose - in fact I think it should be applied for more than acetaminophen. They should make the tobacco companies print the surgeon general's warning in black background/white tax (cept in cases when the box itself is black :p cause ya know the tobacco companies will try that one.)

    Don't think they should be limiting the acetaminophen though.
  17. chibi curmudgeon
    Re: Life Without Vicodin Will Be OK, Doctors Say

    This just illustrates how ignorant people are of the drugs they're taking. Do they even realize Vicodin is two different drugs?? If they don't, that strengthens the FDA's case even more! These people apparently don't understand why they shouldn't take Vicodin and Tylenol together, and that's exactly the reason why we need to get rid of the combinations. Some patients are just too dumb to understand "Vicodin HAS TYLENOL IN IT." :( Maybe this'll also drive home the point that just because a drug is over the counter that doesn't mean it's safe to take the whole bottle.

    chibi curmudgeon added 2 Minutes and 46 Seconds later...

    The warning label on cigarettes (in the U.S., at least) is already pretty much in the same black box style, except larger.
  18. Johan73
    By Patty Fisher, Mercury News
    Updated: 07/06/2009 09:06:40 AM PDT

  19. Stimulants
    I read in news article related to this recent ban proposal that greater portion of acetaminophen poisoning is caused by prescription formulation containing acetaminophen. I wonder how much of that is due to patient non-compliance or being used by someone other than the patient for non medical purpose.

    I find it interesting that they're looking closely at oxy/APAP and hydro/APAP combos.

    FDA shouldn't really be doing anything because a medication is dangerous when not taken as prescribed, however their action is justified if it is dangerous when used properly.
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