FDA approves drug 10 times as potent as Vicoden

[theHandpuppet]

Source: The Portsmouth Times

FDA approves drug 10 times as potent as Vicoden
Local expert blasts FDA
by By Frank Lewis

PDT Staff Writer

Anti-prescription drug abuse activist Lisa Roberts, RN, of the Portsmouth Health Department, says the Food and Drug Administration ignored it own panel and approved a new Hydrocodone drug called Zohydro which she says is 10 times more potent than Vicodin.

Roberts, speaking with the Daily Times from Michigan where she was serving this week as a presenter at their state Prescription Drug Summit, said, “They (FDA) continue to approve more blockbuster painkillers. Yesterday (Monday) they ignored their own panels recommendations and approved a new pure Hydrocodone product called Zohydro which has no built in abuse deterrent and is 10 times more potent than Vicodin.”

According to a watchdog report in the Milwaukee-Wisconsin Journal Sentinel, against the recommendation of its own advisers, the U.S. Food and Drug Administration has approved a new high-dose narcotic painkiller without an abuse-limiting formula and tested using a method critics describe as stacking the deck in favor of the drug.

Zohydro ER will be the first Hydrocodone-only opioid, and it will come in doses packing five to 10 times more heroin-like narcotic than traditional Hydrocodone products such as Vicodin, which combine Hydrocodone with over-the-counter pain relievers such as Acetaminophen or Ibuprofen....


Read more: http://www.portsmouth-dailytimes.com/news/home_top-news/2706662/FDA-approves-drug-10-times-as-potent-as-Vicoden

---

Hoo-boy. I'm sure there won't be any abuses of this new drug.

[truedelphi]

1. Meanwhile the FDA's scare tactics against standard, patent expired drugs that

Are cheap and relatively few serious side effects, continue unabated.

[elehhhhna]

76. Do you know what she means by thiese beloved, helpful built in "antiabuse" features???

???

She means acitomenophen (Tylenol) which is unnecessary but put into many opiods so that if you overdo them, your liver will be destroyed.

Organ failure/death; the antiabuse feature. What bullshit.

Thank god ACA will give people who desperately want recovery the access they need to detox/inpatient programs

[truedelphi]

78. No, please, I certainly do not mean Tylenol, which doesn't seem

To be discussed negatively among current FDA members, as they have allowed it to be put inside far too many medications. I agree with your negative statements about Tylenol.

But, Why put words into my mouth?

I was thinking of benadryl. There is a campaign out against this drug, in part because its patents have expired, and so it is cheap and effective. And the drugs they mention as being replacements have not only the same side effects, but even worse side effects.

[bemildred]

79. It is not wise to combine Benadryl with other downers.

Just saying.

[elehhhhna]

83. oops sorry True, I was responding to the woman quoted in the OP

[truthisfreedom]

2. What a nightmare!

Jeepers!

[warrant46]

12. Well--- when Lung Cancer Strikes

Those making fun of it NOW----will be on their knees begging for it

[markpkessinger]

42. I lost both parents to lung cancer . . .

. . . and they each had remarkably little pain. My mother took one -- ONE -- oxycodone pill in the course of her entire illness, and that was on the day before she died.

[warrant46]

45. They were fortunate not to have pain ---see # 37 below

Not fortunate to have the disease, but fortunate the pain part of it, and didn't require demerol and other opiates.

It was awful watching someone lose almost 100 pounds.

The autopsy weight was 47 pounds.

A closed casket for the memory with a beautiful young photo on top

[Trillo]

47. 39.3% of lung cancer patients experience frequent or persistent pain

http://onlinelibrary.wiley.com/doi/10.1002/1097-0142%2819920915%2970:6%3C1616::AID-CNCR2820700630%3E3.0.CO;2-7/abstract

[kardonb]

44. well...

btw, the proper name is Vicodin (acetaminophen and codeine ) .

[warrant46]

46. I can spell !!! you mean to educate theHandpuppet

[truthisfreedom]

59. There is morphine. My father was on it as he died from pancreatic cancer.

[PasadenaTrudy]

65. My sis too

died of pancreatic cancer. Thank goodness for the morphine pump. Horrible disease.

[HuckleB]

70. Indeed.

[YellowSnow]

3. Sounds fun!

[gopiscrap]

27. welcome to DU how did you come up with that name?

[KamaAina]

40. I'm assuming from Zappa

[demosincebirth]

51. I know an old joke about yellow snow and the Gipper.

[jmowreader]

4. It probably already has a street name

[Snake Plissken]

16. I heard they're called Limbaughs on the street

[CFLDem]

23. Zing!

[jmowreader]

56. They should be called Gohmerts

'Cause they'll make you stupid and dangerous.

[Turbineguy]

5. Maybe the FDA is getting ready

for Ted Cruz as President.

[cosmicone]

6. I'd want propofol if he is elected

hydrocodone won't cut it at all!

[BlueJac]

7. Just let me have some pot....

[TexasTowelie]

18. +1

[CFLDem]

24. No

that's too dangerous for your health.

[Dopers_Greed]

8. Pharma CEOs are going to make a ton of $$$ off this

I can only hope their own kids are the ones who get addicted to it.

[Warpy]

10. While I hope Ms Roberts gets Nurse Tylenol assigned to her

if she ever needs major surgery.

[seveneyes]

68. Fuck that noise

Nobody should have to live with pain and nobody should wish addiction upon anyone. When the ills and addiction of alcohol are solved, then I'll worry about something that was designed and manufactured to help people. There is no reason to make life harder on people than it already is.

[Warpy]

9. She's either lying or too stupid to know

that the active opiate in Vicodin is hydrocodone. They've simply released it as a single drug for people who can't tolerate the Tylenol in Vicodin and Lortab, the preparations most widely available. In addition, the new form will be time released, meaning that several single dosages are combined in one tablet to be released over 12 hours or so.

Since she survived nursing school, I tend to believe she's a typical drug warrior, lying through her capped teeth to grab some headlines. I guess the ninny doesn't realize that a lot of the rest of us out here also survived nursing school and can see right through her faked hysterics.

[Tien1985]

53. Don't let a silly

Little thing like facts get in the way of taking cancer patient's pain killers away.

[Mojorabbit]

57. Great post! (from a retired RN) nt

[KansDem]

11. I think I was prescribed Vicoden several years ago

Is it used to lessen the pain of a root canal?

[BainsBane]

15. Yes, and it's not that strong

My experience is it made me hot more than anything.

[KansDem]

21. Thanks...

My root canal wasn't all that bad but I do remember wondering about the effectiveness of the pain killer. I remember thinking "This is no better than a big aspirin!" I suppose wondering about that took my mind off the root canal.

[QuestForSense]

13. FDA Recommends Tightening Access To Hydrocodone Pain-Killers

Sort of confusing. This was posted here last week, but it says nothing about Zohydro ER:

http://www.democraticunderground.com/1014630710#post28

[sharp_stick]

19. The FDA is considering

adding hydrocodone to the Schedule II list of drugs making it harder to get refills. This would put Zohydro on the Sched II list if it happens.

[Sgent]

14. This is a good thing

although there will be abusers, vicoden was needlessly putting peoples health in danger from an OD of tylenol -- especially those with an already damaged liver.

Hydrocodone is a much better drug for certain types of pain management than other available ones -- such as oxycotin, etc.

[D23MIURG23]

26. +1

[hunter]

61. Yep. Even addicts don't deserve tylenol overdoses.

These idiotic puritanical authoritarians are often the same sort who think pregnancy is a punishment for sex.

Addictions and unwanted pregnancies are a public health problem. Punishment is not a solution.

Painful health problems that respond to meds, people enjoying sex, people having babies, those are normal life.

[sharp_stick]

17. Vicodin is hydrocodone

this is just hydrocodone available without the tylenol additive. There's nothing new about it.

If you're thinking more potent you just have to look at oxycodone (percocet), hydromorphone hydrochloride (dilaudid) and fentanyl for narcotics that are far more powerful than hydrocodone.

[heaven05]

20. Soma

keep em drugged, won't cause trouble except problems caused by thugs killing for them to sell them on the streets for 1/3 price. Or more addicted people. Oh yeah, already mentioned that. Real pity what this country is turning into. I know, dumb post. Yet I was truly affected by Huxley's 'Brave New World'

[PatrynXX]

22. why Ritalin is regulated as a narcotic

I have no idea. it isn't it's a stimulant . not really addicting either bug Vicodin sure is. and my Dr knew it so he yanked me off it.

[D23MIURG23]

25. So what?

This is really no different than other hardcore pain killers like Oxycontin or Dilaudid. Both of those medications are abused, but both of them have legitimate uses in medicine, and their use should be at the discretion of physicians. Using acetaminophen as an 'abuse deterrent' is a stupid idea, because people will still abuse the medication, and they will damage their livers in the process.

[Orangepeel]

28. Good. It's dumb to put Tylenol in Vicodin

"Abuse deterrent" . Phhhhttt. Like people are going to think, "I was going to abuse my painkiller, but I guess I won't because it will damage my liver."

[Humanist_Activist]

29. If we only approve drugs with no potential for abuse, many people will needlessly suffer...

So I don't understand your last sentence. Both my grandfather and my dad went in for open heart surgeries, and both were given Morphine during recovery, should they not have been given that?

My own mother, during her hospice care, was given a cocktail of extremely strong narcotics to manage her pain till the end, should we have worried that she became addicted before she died?

If people become abusers, then we should provide counseling and aid when needed.

[bobGandolf]

74. Too many just see abuse potential, and

ignore the pain reduction benefit for those suffering every day.

[Humanist_Activist]

75. Yeah, also the fringe benefits...

I remember, the day after my grandfather's surgery, we were able to see him in the hospital, and he was high as a kite, he's normally goofy when sober, multiply that by a thousand on morphine and whatever else they gave him.

He was able to be his normal goofy self for over 10 years after his surgery, we will always be happy for that.

[cliffordu]

30. Well, at least the street prices for OXY will come down......

[mucifer]

31. Pediatric hospice nurse here:

I'm guessing you aren't thinking about this from the point of view of someone suffering from end stage cancer or other horribly disfiguring painful diseases that I see on a routine basis.

We need choices in what narcotics we order. We often rotate them and go down on the doses when we do this because people build up tolerances. Different people respond better to different meds. For some people morphine works best. For some people dilaudid works best. I'm looking forward to seeing if medical marijuana might help some of my patients when it becomes available in my state.

Think about what it is like to have tumors growing and growing inside of you that do not respond to treatments. Sometimes all we can do is to try to control the pain. The pediatric oncologists have come a long way in treating cancers and most kids do survive. But, for those who don't, I want doctors trained in comfort management ordering medications.

To say that a medication is 10 times more potent than Vicodin is a good thing. You would not believe the amounts of medications that some people require when they are dying. Some require nothing. Some require astounding amounts of IV morphine or IV dilaudid. The high doses are increased slowly over time. I have never had a narcotic. While the medications some of my young patients take that they require are at high doses, some of these kids are very alert on these doses that would totally knock me out or worse. It's because their pain receptors require it. Having more narcotics available that you can rotate is a basic principle of hospice comfort care.

This staff writer who wrote this article should have interviewed an expert in hospice care.

I say "Thank you FDA!"

[theHandpuppet]

32. Thanks for your perspective

I guess no matter what new drug hits the market, someone will always abuse it. In the meantime, it can give relief to the suffering.

[mucifer]

33. Yeah, and it's so hard for us to educate people about using narcotics

for end of life care when articles like this come out.

People are often afraid to give morphine to their children.

It's really sad.

[warrant46]

34. Thank you see # 12 Above

When a 45 pound woman who used to weigh 137 in the prime of life screams continuously from the pain of Advanced Stage 4 Cancer.

These Drug Warriors will change their tune when it's them.

[mucifer]

35. Yup, and for a patient who responds better to

vicodin than oxyodone this is great news. Because the you can go up very high on oxycodone doses, but not vicodin.

[warrant46]

37. I watched it happen it was heart breaking

[mucifer]

48. I'm sorry to hear that.

[warrant46]

49. Thanks-- We will all face something like this some day n/t

[madrchsod]

36. i watched my brother in law die do to cancer

he smoke medicinal grass with the standard medicines untill the last few days of his life. the last few days none of the medicines were working and he was in pain. i`m sure this new class of medicines would have made his journey more comfortable.

his best friend died of the same cancer several days before my brother in law died. he took all his medicines at once because he knew what was going to happen and he had no one to really comfort him. both were in nam,in the same unit,and exposed to the same chemicals.

prolonging death is no comfort to the dieing

[davidpdx]

58. I also thank you for providing the perspective of someone who is in the medical field

It does scare me though that stuff this powerful is on the market. Mostly the potential for abuse. I understand that would happen with most powerful drugs though.

[PasadenaTrudy]

66. My mom, dad, and sister

all died in hospice. I hope when my time comes, the drugs are as strong as possible.

[HuckleB]

69. +1,000,000 ... 000

[Heddi]

38. I'm sad that whoever wrote this headline couldn't spell "VICODIN" correctly

I'm an RN and I agree with the pediatric RN up above. Yes, pain meds are often misused by people, but for people who really truly need them, especially cancer and other end-of-lifers, when treatment isn't an option and palliative care is the only choice, keeping someone out of pain and comfortable is a really big thing.

Increasing a patient's vicodin dose isn't always a great thing to do because there is acetaminophen in vicodin (there's also vicoprofen, which has ibuprofen in it), which harms your liver. Vicoprofen harms your kidneys. So something without the ibuprofen or acetaminophen but with extra pain killer is awesome. Because someone with bone cancer really doesn't need to have kidney or liver failure from their pain meds, too.

[adirondacker]

50. Thanks for clarifying this. Hopefully the critics will read and learn something. nt

[True Blue Door]

39. As long as the money goes to a pharmaceutical company

the FDA considers drug abuse a feature, not a bug. But marijuana is still treated as a dangerous and criminal substance.

[Ed Suspicious]

41. Does the risk of addiction outweigh the pain of end stage cancer? I think not. If I'm on my

deathbed, I'd happily go out comfortably addicted.

[bobGandolf]

73. Me too! n/t

[agent46]

43. Pure genius!

I'm guessing Big Pharma plans on taking over the international Heroin business. It's perfect. Heroin in a pill with guaranteed quality controlled purity and value set by the producer good enough to use as street currency. I'd say the criminal drug trade has a new gold standard.

Given the Machiavellian neoliberal culture of the global corporate mega-industries, my guess is the criminal drug cartels are signing on and the corporate leviathan has grown another tentacle. If this goes to market, the drug industry will be the next arms industry apolitically selling to the highest bidder. It would be consistent with the industry's MO so far.

[GReedDiamond]

52. The FDA should test these "Zohydro" pills on Rush Limbo...nt

[Conium]

54. I itch just thinking about it.

Once the itching has stopped, so has the pain relief, but you will certainly be constipated (which can be even more painful).

A tamper-resistant, time-release meperidine formulation would be better... or just put it in the drinking water.

[sakabatou]

55. Paging Dr. Gregory House...

[Tom Ripley]

60. Yesssss!!!!

[JoeyT]

62. Good. Now people with severe pain can get relief without having to worry about

liver damage. Lisa Roberts can shove her moral crusade right up her ass. I'm more worried about people in pain than her RRRAAGE! that people might abuse a drug, especially one whose active ingredient is one people are abusing anyway. I guess she's of the opinion that addicts are terrible people that totally deserve the damage those "abuse deterrents" cause.

[Conium]

63. Better monitoring is needed.

Have the patient log their dosage with the doctor via text messaging or email. Occasionally require photos or actual inspection of the remaining prescription.

[Boudica the Lyoness]

71. I hope you are kidding

If you are serious, I hope you, one day soon, have to live in the pain I am in, every fucking day for the rest of your life.

[bemildred]

72. Word. nt

[HuckleB]

77. You are correct, and you are in the right.

Still, I can't abide by wishing pain upon others. Peace be with you.

[Conium]

84. Yes I am serious.

What's wrong with making sure these dangerous drugs are actually being used by the patient and not being sold on the street? What is so difficult about sending a text or snapping a picture?

Cursing me with your "pain" can only be a blessing. I have dealt with severe pain everyday for nearly 30 years. I can tell you from experience that opiates do not help very much for chronic pain. But I understand your anger. It's the drugs talking.

[Myrina]

64. Oh, sure, it's gotta be something I can't take ...

.... Hydrocodone, Tylenol with Coedine, anything like that makes me puke my socks off.

No turbo buzz for me. Sigh.

[bemildred]

67. That should reduce the number of deaths from liver failure right there.

And she thinks that's BAD?

[Ava Gadro]

80. Does that mean it will make me ten times sicker to my stomach?

[Conium]

85. Exactly.

Ten times more constipated, too. (which can be extremely painful!)