FDA Panel Votes To Place Tighter Controls On Narcotics Like Vicodin

[Purveyor]

A U.S. Food and Drug Administration panel voted Friday to place stricter controls on popular narcotic painkillers such as a Vicodin.

The 19 to 10 vote, which is advisory, will help the FDA decide whether to recommend moving drugs such as Vicodin, which contain the opioid painkiller, hydrocodone, from Schedule III to Schedule II under the Controlled Substances Act.

---CLIP
Stricter Schedule II status means that fewer prescriptions can be written at one time. For each visit to the doctor, a patient can get up to six months of prescriptions of Schedule III opioids such as Vicodin, compared with up to three months for Schedule II drugs.

Schedule II drugs also have stricter handling and storage requirements.

It was not known when the FDA would make a final decision on the issue.

MORE...

http://www.jsonline.com/features/health/fda-panel-votes-to-place-tighter-controls-on-narcotics-like-vicodin-k28h6hl-188396901.html

MORE from NYT:

The change would have sweeping consequences for doctors, pharmacists and patients. Under the new rules, refills without a new prescription would be forbidden, as would faxed prescriptions and those called in by phone. Only written prescriptions from a doctor would be allowed and pharmacists and distributors would be required to store the drugs in special vaults. The vote comes after similar legislation in Congress failed last year, after intense lobbying by pharmacists and drugstores.

http://www.nytimes.com/2013/01/26/health/fda-vote-on-restricting-hydrocodone-products-vicodin.html?_r=0

[Kurska]

1. Screw people's pain, there are guys out there getting unauthorized highs from these drugs!

Our war on drugs never fails to get more disgusting.

[godai]

2. 3 months supply per Rx seems adequate.

These are addicting drugs and Big Pharma has pushed them excessively.

[Kurska]

3. I'm sure you'd be singing the same tune if it was your terrible pain we were talking about.

This is just part of the picture, it keeps getting harder and harder for people with real need to get these kinds of drugs. The government is really starting to crack down, people with broken bones ending up with advil.

Again what is one human's intense physical suffering compared to preventing another human from having an intense high?

[godai]

7. Hard to get for drug abusers.

I got Vicodin Rx following tooth extraction.

[Kurska]

10. Yeah, that is what they are trying to change

Do a little research, those types of scripts are the very things they are trying to eliminate first.

[godai]

12. It was just 12 tablets, no refills.

Fairly common, I think.

[godai]

38. Not at all.

No one would get a 3-6 month Rx for Vicodin following tooth extraction. It's the phony back pain etc. re-sellers that they're after. I'm surprised to learn that some posters here actually know the street price for illegal Vicodin. Hmmmm.

[Kurska]

45. Yeah, because this is clearly the only story or regulation currently out there to limit vicodin. n/t

[REP]

11. Wow, a tooth extraction.

I have immune-mediated polyarthritis. I have no cartilage in the joints of my shoulders. Due to another serious, chronic disease, I can only take narcotics, like Vicodin, safely to try to control the pain.

Yes, you may have been over prescribed for your extraction.

[OneTenthofOnePercent]

16. So a three months supply of pain medication is not sufficient?

Get a written perscrition, and then have it filled as infrequently as 3 months... I think that's a common sense restriction. Or are they talking about completely removing vicodin from people with immune-mediated polyarthritis?

[godai]

18. No change in when it's used. 3 month Rx limit is only change. n/t

[Mojorabbit]

28. What will happen is they will start here

Doctors will be subtly pressured into not writing the rx. My husband is a family doc and he is paranoid anymore writing pain prescriptions. The DEA keeps an eye on what rx for pain you are writing and too many will trigger an investigation. It is getting ridiculous.

[Aerows]

39. I was also prescribed Vicodin for a tooth extraction

Mind you, they were impacted wisdom teeth that had to be dug out. It isn't at all uncommon to get strong pain relievers following oral surgery.

[MissB]

15. May you never walk in dh's shoes.

He has severe back pain, because his spinal bones are slowly fusing together from Ankylosing spondylitis. Actually, they used to be slowly fusing, now they fusing faster. His dr was shocked last year when he reviewed his X-ray.

He gets a script for a Vicodin a day. Some days it isn't enough.

If you'd like to read more about this particular form of arthritis, go here:http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001457/

It typically hits men in their 30s, though it occasionally hits women as well. Surgery hasn't been a hugely effective treatment. There is a drug to slow the progression, but it tends to trash the liver or kidney (can't recall which). Dh is 53. He bikes 20 miles/day. Someday in the near future, he will no longer be able to, for fear of his neck snapping. Even riding in a car will be dicey - a rear end collision could snap his neck too.

I can't imagine it will be useful for him to have to go to the dr twice per year to get a new script. Utter nonsense.

[godai]

17. 15,000 deaths from overdose of these drugs yearly.

Try to understand that. One tablet per day is inadequate for what you describe. If true, doctor should prescribe more daily.

http://abcnews.go.com/Health/prescription-painkiller-overdose-deaths-rise/story?id=14858375

[Mariana]

24. I wonder how many of them die from acetominophen toxicity

rather than narcotic overdose. Lots of these prescription painkillers contain high doses of acetominophen together with a rather small amount of the narcotic.

[blue neen]

29. There is definitely a problem because of the acetaminophen dosages.

There are formulations of hydrocodone/apap that have lower dosages of the acetaminophen than Vicodin. They're also very effective for pain relief.

[Purveyor]

36. I read a few months back that applications have been file to the FDA to produce Vicodin without

the acetaminophen just because of this.

Very potent and if approved, definitely a schedule II drug.

[godai]

37. There already is HC plus ibuprofen.

Vicoprofen...The addiction problem is with hydrocodone. You'd have to take about 12 Vicodin a day to get acetaminophen liver damage.

http://www.medicinenet.com/hydrocodone-ibuprofen-oral/article.htm

[Purveyor]

41. This is the stuff I heard about, Zohydro. Straight up hydrocodone.

About Zohydro

Zohydro is a novel, oral, single-entity (without acetaminophen) extended-release formulation of various strengths of hydrocodone intended for administration every 12 hours for around the clock management of moderate to severe chronic pain. If approved, Zohydro could be the first hydrocodone product to offer the benefit of less frequent dosing and the ability to treat patients with chronic pain without the risk of acetaminophen-related liver injury. Currently, hydrocodone is only available in immediate-release, combination products, most commonly with the analgesic acetaminophen, and requires dosing every 4 to 6 hours. Zohydro, classified as a Drug Enforcement Agency (DEA) Schedule II drug product, would carry more strict prescription and dispensing rules as compared to the currently available hydrocodone combination products. In addition, Zogenix has included in the NDA a comprehensive Risk Evaluation and Mitigation Strategy (REMS) that is consistent with current FDA and industry-wide guidelines for extended-release opioid products. The REMS is intended to control inappropriate prescribing, misuse and abuse of extended-release opioids while maintaining patient access to essential pain medications.

Complete report: http://www.drugs.com/nda/zohydro_120502.html

[blue neen]

42. Actually, in older people and others who have chronic health problems,

it wouldn't really take as many as 12 Vicodins to cause liver damage.

Another thing that people don't realize is that acetaminophen is an ingredient in many common over the counter medications. Such meds as Midol, Benadryl formulations, Nyquil, and Sudafed contain apap, and the consumers don't realize it. Liver toxicity can occur without one knowing what is happening.

Some cannot take any medications that contain ibuprofen, particularly those who have bleeding disorders. It is also very hard on the stomach.

There is no easy answer to addiction problems, but there is a genuine need for pain medications. What regimen works for one person is not always what is do-able for someone else.

[MissB]

25. May you never feel the sort of pain that requires Vicodin.

Try to understand that.

[godai]

32. Vicodin is readily available!

Anyone with issues about a 3 month Rx restriction seems to like Vicodin a little too much.

[bama_blue_dot]

33. Wow, you are ignorant..

You act as if people with these painful conditions can get Vicodin so easily.. My DH is 30, and also has Ankylosing Spondylitis, and he has struggled for years to even find a doctor who would write him a prescription for pain meds.. The people that needs the meds find it almost impossible to get them..

[godai]

34. Doctors must have a reason for refusing to prescribe, in your situation. n/t

[bama_blue_dot]

40. Most give the same generic answers.

My husband even got referred to a pain management clinic, and we figured we would have better luck there, but they basically didn't care that he was diagnosed as having Ankylosing Spondylitis, and they said: "Well, we think your problem is muscular, so we can't give you pain meds for that" My DH was so distraught because he has been suffering with this since 2004.. We were finally lucky enough to find a doctor that basically exists just to shell out pain meds.. We have no insurance, so we have to pay $90 for the visit, then another $35 to get the pills filled, but it helps him get through the day without feeling like he can't get out of bed..

I wish they would just legalize Marijuana, because he seems to get some relief from that as well, but we live in Alabama, so that's not going to happen.. Everyone's story is different.. Not everyone is a junkie, and not everyone is selling every pill they have.. He can only get 60 pills a month anyway.. He has also never been able to have a 3 or 6 month prescription.. I have never heard of that.. My dad lives in NY, and he has to personally go to his doc every month to get a script..

[godai]

43. Has he tried 800 mg ibuprofen (otc)?

Sorry to hear about your husband's difficulties. I would think Vicodin throughout the day would cause a lot of drowsiness. Ibuprofen (an NSAID) can be rough on the stomach but maybe worth a try, to see if it relieves some pain. Relief only lasts 4 hours. Might be an alternative to Vicodin only dosing.

Will Obamacare hopefully get you insurance?

Seems like opioids are not recommended for AS...
http://www.spondylitis.org/about/as_treat.aspx

NSAIDs (nonsteroidal anti-inflammatory drugs) are still the cornerstone of treatment and the first stage of medication in treating the pain and stiffness associated with AS. However, NSAIDs can cause significant side effects, in particular, damage to the gastrointestinal tract.

When NSAIDs are not enough, the next stage of medications, (also known as second line medications), are sometimes called disease modifying anti-rheumatic drugs. This group of medications include: Sulfasalazine, Methotrexate and Corticosteroids.

The most recent and most promising medications for treating ankylosing spondylitis are the biologics, or TNF Blockers. These drugs have been shown to be highly effective in treating not only the arthritis of the joints, but also the spinal arthritis. Included in this group are Enbrel, Remicade and Humira.

[bama_blue_dot]

44. Thank you for the detailed reply!

He was diagnosed with Ankylosing Spondylitis only based on the fact that he tested positive for the HBLA-27 gene, and honestly, it states that even if you have this gene, you may never develop AS.. The only real symptom he has that can be associated with AS, is the stiffness. We really are not convinced that he has AS, at least I hope he doesn't.. Most of his symptoms seem to match up better with Fibromyalgia, which does run in his family..

He has tried the 800mg Ibuprofen, with no help.. The pain meds, fortunately don't make him drowsy.. He is one of the lucky ones who seems to have more energy after he takes it. I think that may also be because his pain is dulled quite a bit.. We are also very worried about the problems that NSAIDS cause, so we have had his doc lower the amount in his pain meds..

Obamacare will not help me because I live in Alabama, with no income, so I would qualify for medicaid, well guess what.. He won't expland the medicaid.. My husband is a veteran, so if he really needs to see a specialist he has to drive to Birmingham,AL. Which is 2 1.2 hours away from us. Obviously we will have to go that route though.. He has an appointment Monday for his VA physical to determine if his disability percentage can be increased from 10% to hopefully 20 or 30%.. We are also in the process of filing an appeal for SSDI..

[MotherPetrie]

4. You are so right.

[Purveyor]

21. You can buy then all day and night long on the street...for $4 a pill and most every damn one of the

from legit scripts.

Gal down the street claims to have some mysterious pain, doesn't take a one of them...but happy to sell them to you.

Every month, she gets a supply of 90 pills....3 a day X 30, directed by doc. Nice profit...indeed.

Of course, she only pays $8 a bottle.

Just saying...

[madrchsod]

31. depending on the med it`s up to $10 where i live.

[cthulu2016]

5. Y'know... fuck the FDA.

[godai]

6. This was an Advisory Committee, not FDA. n/t

[cthulu2016]

13. Sorry... Fuck the Advisory Committee

[godai]

14. Vote was 19/10. You agree with 10 of these experts. n/t

[Go Vols]

8. Its already

like this in Tenn.

[union_maid]

9. Seems like the larger problem is people without prescriptions

You know...holding up pharmacies, killing people in them and whatnot. I'm not sure making it harder to get the drug is going to be the answer to those things.

[TheKentuckian]

20. Past time to let folks put into their bodies what they elect

and cease and desist wringing our national hands if someone somewhere cops a buzz.

Yes, some will die but it will be their choice.

[Purveyor]

22. "Yes, some will die but it will be their choice." The sooner the better in most cases, eh? eom

[EastKYLiberal]

23. It is an epidemic here in Appalachia. And one of the main issues people care about...

Even with all the poverty.

[RedCappedBandit]

26. So patients with valid medical needs

will simply have to go to the same doctor more often to receive the same meds over and over again? Sounds like a waste of money.

[Purveyor]

27. And those docs with be able to bill for the re-up doctor visit. eom

[bananas]

30. Fax and phone refills will be forbidden?

"The change would have sweeping consequences for doctors, pharmacists and patients. Under the new rules, refills without a new prescription would be forbidden, as would faxed prescriptions and those called in by phone. Only written prescriptions from a doctor would be allowed"

[Purveyor]

35. Yep. I trip to the doctor every 3 months of a written script then to be hand delivered to the

pharmacy.