by Admin
If 2 Painkillers Are Banned, What Next?
Jul 05, 2009
By: Amanda Gardner
Health Day
THURSDAY, July 2 (HealthDay News) — Banning the popular painkillers Percocet and Vicodin, which a U.S. health advisory panel has urged, would not be as drastic as it sounds, some medical experts contend.
The reason, they say, is that other options are available.
A U.S. Food and Drug Administration advisory panel made its recommendation Tuesday. It followed the release in May of an FDA report that found that many consumers aren’t aware that severe liver damage, and even death, can result from overuse of acetaminophen, which is easier on the stomach than such painkillers as aspirin and ibuprofen.
Vicodin and Percocet combine acetaminophen with an opiate narcotic in one pill. Vicodin contains the narcotic hydrocodone, and Percocet contains oxycodone. Both drugs are prescribed to treat moderate to severe pain.
But acetaminophen is the active ingredient in such popular over-the-counter pain relievers as Tylenol and Excedrin. And consumers may also not know that acetaminophen is present in many other over-the-counter products, including remedies for colds, headaches and fevers, making it possible to exceed the recommended acetaminophen dose.
And that’s what’s prompting the FDA’s concern.
“It really makes sense to do what the panel is suggesting,” said Dr. Scott Fishman, chief of the pain medicine division and a professor of anesthesiology at the University of California, Davis, and president of the American Pain Foundation. “The key is that the public needs to understand that they [the FDA] are not voting to ban the drugs [contained in the pill: the opiate and acetaminophen]. The drugs are fine. It’s the combination of the drugs in one pill. Each drug has its own problems but, used separately, can be used safely.”
Narcotic painkillers such as hydrocodone and oxycodone run the risk of being abused. “We want to get tighter control,” Fishman said.
Using two pills instead of one, if needed, would enable physicians to better fine-tune the amount of each drug that their patients would be getting, reducing the risk of an overdose of acetaminophen. An estimated 42,000 Americans are treated in hospitals each year for acetaminophen overdoses, half of which are accidental.
“I agree in theory with what they [the FDA advisers] are doing because … even though experts say 4,000 milligrams [of acetaminophen] is a toxic dose, some people believe as little as 2,000 can cause liver problems,” said Dr. Joseph Shurman, chairman of pain management at Scripps Memorial Hospital in La Jolla, Calif.
And some people can achieve pain relief from just one of the components in Percocet, he explained.
Oxycodone alone is “probably just as effective for pain,” Shurman said. “Tylenol [acetaminophen] theoretically is for pain and fever, but some people question if it has an anti-inflammatory effect. We’re not sure of the exact mechanism.”
Currently there is no pill that contains hydrocodone alone, but Shurman said that a slow-release version is close to arriving on the market.
Patients and doctors do need to guard against using too much of either the narcotic or the acetaminophen if only one is being taken at a time, Shurman said.
But an even bigger concern, he said, is use of over-the-counter acetaminophen products, of which Tylenol and Excedrin are among the most popular.
“People can walk into [a store] and buy a bottle of Tylenol and take 10 pills of 500 milligrams each so it’s over the toxic level,” Shurman said. “We know that a significant number of patients don’t follow doctor’s directions, especially if they’re in pain.”
The FDA panel called for lowering the recommended maximum daily dose of nonprescription acetaminophen, which is currently 4 grams — equal to eight 500-milligram pills of a drug such as Extra Strength Tylenol. The panel was not asked to recommend another maximum daily dose.
The panel also voted to limit the maximum single dose of acetaminophen to 650 milligrams (two pills of 325 milligrams each). The current single dose of Extra Strength Tylenol, for instance, is 1,000 milligrams (two 500-milligram pills). The 1,000-milligram dose should be available only by prescription, the panel said.
The FDA is not obligated to follow the recommendations of its advisory panels, but it typically does so, and Fishman predicted it would in this case as well.
“While it’s very convenient to have them in one pill, safety trumps convenience,” Fishman said.
Dr. Sandra L. Kweder, deputy director of the FDA’s Office of New Drugs at the Center for Drug Evaluation and Research, gave a strong hint Tuesday of what the agency might do with the advisory panel’s recommendations.
“I think the top recommendation of this committee was that the agency needs to do something to address and decrease the usual dose of acetaminophen, both for over-the-counter products and also prescription combination products,” Kweder said during a press conference.
She added, “There was a clear message that there is a high likelihood of overdose from prescription narcotic/acetaminophen combination products. If we don’t eliminate these combination products, we should certainly at least lower the usual acetaminophen dose patients receive in those prescription combination products.”
At the very least the FDA should require new warning labels on these prescription combinations that alert patients to the potential of liver damage if they take too much acetaminophen, she said.
More information
The U.S. National Library of Medicine has more on acetaminophen.
http://healthday.com/Article.asp?AID=628672
““It really makes sense to do what the panel is suggesting,” said Dr. Scott Fishman, chief of the pain medicine division and a professor of anesthesiology at the University of California, Davis, and president of the American Pain Foundation.”
I wonder what it is about anesthesiologists? More than anyone except maybe “Interventional Pain Management Specialists,” they all seem to have a bad case of rectocranial juxtaposition which causes them to see things somewhat bass-ackwards: “Pain patients have psychological problems, therefor the psych troubles must be causing the pain, so treat the psych trouble. If the pain doesn’t respond, treat the psych problems some more…” You know?
The problem here, you degreed IDIOT, is that too many doctors are trying to treat high levels of pain with low levels of already low-level opiates. If you were to listen to the patient and when you’re told that the medication is inadequate, either raise it to a safe but higher dose or switch to a more powerful opiate, you’d cut out the vast majority of those APAP ODs. The thing is, you’d have to spot a pain patient there in your office and begin treatment AS you run diagnostics instead of making the patient wait for months or even years before you get around to actually treating the pain even close to adequately – if you ever do.
Ian MacLeod
Activist PRN. Nonprofit, Nonpartisan, 501(C)(3) Corporation.
Illegitimis non carborundum!
The PRN folks are so spot-on in their observations. Perhaps because most, if not all, actually live with the ravages and frustration of chronic pain.
Yes, APAP is bad. Most Chronic Pain patients learn this once they become educated through organizations like PRN.
APAP is also good as an ingredient in some pain relievers (we must stop calling them “painkillers”, IMO).
Taking the mega-dose OTC 1000mg products off the store shelves is perhaps one step in the right direction. Still, it will have little impact on the statistics of APAP related overdoses.
One suffering with Chronic Intractable Pain, either because they are uninformed or desperate for some relief will simply take a pair of 500mg, a trio of 325mg, etc.
That is, we will do that in the absence of the often elusive more effective prescription pain relievers that far too many Doctors are wont to prescribe. The ones with those names that have become synonymous with abuse rather than relief even though those helped by these medications far outnumber the abusers.
Before I knew better and before my pain was taken with even a modicum of seriousness, I thought if it was on the store shelves promising “Extra Strength Relief”, it couldn’t hurt you. Now in this current climate without a Doctor sympathetic to my pain, I’m off to the store shelves again. Despite the fact that I know the relief I get from simple APAP is fleeting at best. Despite the risks (I do take my NAC 600).
I wish I could find the citation again, but last year the DEA modified the quotas it imposes on the major pharmaceutical manufacturers. It was decided that production of the 10/325 hydrocodone/apap combination should be further curtailed since it was cited as the “choice drug of abusers”.
“bass-ackwards” – I love that term and I’m seeing it more and more when I hear folks speak of this recent FDA Advisory Panel recommendation.
1) First, the very definition of an abuser is a person who continues a dangerous behaviour despite the negative consequences. One who has indeed fallen victim to opioid abuse will take any pill available, APAP concerns are sadly way down on the list.
2) Even if the lower dose hydro/apap combo medications were indeed the “choice drug of abusers”, what ever happened to the concept of “harm reduction”? It’s a politically correct, accepted method to minimize the health hazards others who engage in dangerous behaviour are accorded.
I have sympathy for those who abuse prescription medication. Any Chronic Pain patient well knows it’s a slippery slope between theraputic dosage and building a tolerance that could be construed as “abuse”.
We need and mostly ackowledge the fact that we must be ever vigilant as to how we handle our medication. That is, should we be fortunate enough to find a sympathetic Doctor in this current culture of Celebrity Rehab and Relapse.
3) It appears the right hand doesn’t know what the left hand is doing. At the same time the FDA suggests lower APAP dosages might prove safer, the DEA is curtailing production of such. Absurd!
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I’ve been on a far too protracted roller coaster of compassionate Physician, to no understanding Physician, to treatment that concludes that I must be depressed because I refuse to live with this near unrelenting pain.
I’ve been through the regimen more than once of treatment with the latest anti-depressent cum pain reliever and the results wreaked havoc on my life.
I’ve learned to never utter the word “depressed” when discussing my pain. I’m frustrated, angry, determined, but never depressed.
Has it worked? Sadly no. Without a treating Physician right now, I reached for the bottle of 500mg “Rapid Release Geltab” while writing this. Even though intellectually I know it will put but a 20 minute dent in my pain if I’m lucky. As far as health concerns at this maddeningly frustrating time in my life, well what kind of healthful life am I living now anyway? I forego near every facet of a “normal life” planning every simple movement around futile attempts at lessening truly Chronic Pain. I’m capable of so much if I’m not constantly focused on pain, pain, pain.
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I thank and actively support the efforts of organizations like PRN who are helping to give us a voice. Thank you for letting me comment on the inanity of this most recent, poorly thought out “curve ball” we’ve been hit with. It will help me plead my case better, yet again, come Monday when I see the Doctor.
I’ve gotten used to sympathy from Doctors but little else except for respites that are always cruelly taken away from me, seemingly at whim so many times over the past seven years.
I fear losing a decade of my life to pain, but am determined to keep trying. Will the competing government agencies agree on a “safe” treatment for Chronic Pain patients before that decade is up?
I wouldn’t ramble on unless I believed my Kafkaesque journey didn’t mimic the plight of millions of other Americans.
Thank you.
HalfLife