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Fda Wants Limits On Most Prescribed Painkillers


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FDA wants limits on most prescribed painkillers


 

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Oct 24, 8:04 PM (ET)

By MATTHEW PERRONE

 

Painkillers_FDA.sff_NY148_20131024192700 (AP) In this Feb. 19, 2013 file photo, hydrocodone bitartrate and acetaminophen pills, also known...
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WASHINGTON (AP) - The Food and Drug Administration is recommending new restrictions on prescription medicines containing hydrocodone, the highly addictive painkiller that has grown into the most widely prescribed drug in the U.S.

In a major policy shift, the agency said in an online notice Thursday that hydrocodone-containing drugs should be subject to the same restrictions as other narcotic drugs like oxycodone and morphine.

The move comes more than a decade after the Drug Enforcement Administration first asked the FDA to reclassify hydrocodone so that it would be subject to the same restrictions as other addictive painkilling drugs. The FDA did not issue a formal announcement about its decision, which has long been sought by many patient advocates, doctors and state and federal lawmakers.

For decades, hydrocodone has been easier to prescribe, in part because it is only sold in combination pills and formulas with other non-addictive ingredients like aspirin and acetaminophen.

 

  That ease of access has made it many health care professionals' top choice for treating chronic pain, everything from back pain to arthritis to toothaches.

In 2011, U.S. doctors wrote more than 131 million prescriptions for hydrocodone, making it the most prescribed drug in the country, according to government figures. The ingredient is found in blockbusters drugs like Vicodin as well as dozens of other generic formulations.

It also consistently ranks as the first or second most-abused medicine in the U.S. each year, according to the DEA, alongside oxycodone. Both belong to a family of drugs known as opioids, which also includes heroin, codeine and methadone.

Earlier this year the Centers for Disease Control and Prevention reported that prescription painkiller overdose deaths among women increased about fivefold between 1999 and 2010. Among men, such deaths rose about 3.5-fold. The rise in both death rates is closely tied to a boom in the overall use of prescribed painkillers.

The FDA has long supported the more lax prescribing classification for hydrocodone, which is also backed by professional societies like the American Medical Association.

But the agency's top drug regulator, Dr. Janet Woodcock, said in a statement Thursday: "The FDA has become increasingly concerned about the abuse and misuse of opioid products, which have sadly reached epidemic proportions in certain parts of the United States."

The FDA says it will formally request in early December that hydrocodone be rescheduled as a Schedule II drug, limiting which kinds of medical professionals can write a prescription and how many times it can be refilled.

The Controlled Substances Act, passed in 1970, put hydrocodone drugs in the Schedule III class, which is subject to fewer controls. Under that classification, a prescription for Vicodin can be refilled five times before the patient has to see a physician again. If the drug is reclassified to Schedule II, patients will only be able to receive one 90-day prescription, similar to drugs like OxyContin. The drug could also not be prescribed by nurses and physician assistants.

The FDA's request for reclassification must be approved by officials in other agencies within the Department of Health and Human Services.

News of the FDA decision was applauded by lawmakers from states that have been plagued by prescription drug abuse, many who have been prodding the agency to take action for months.

"Today was a tremendous step forward in fighting the prescription drug abuse epidemic that has ravaged West Virginia and our country," said Democratic Sen. Joe Manchin, in a statement. "Rescheduling hydrocodone from a Schedule III to a Schedule II drug will help prevent these highly addictive drugs from getting into the wrong hands and devastating families and communities

Sen. Charles Schumer of New York noted that the FDA's own expert panel recommended the reclassification more than nine months ago.

"Each day that passes means rising abuse, and even death, at the hands of hydrocodone-based drugs," Schumer said in a statement.

Still, Thursday's action immediately sparked criticism from some professional groups that said that the tighter restrictions could have unintended consequences, such as burdening health care workers and patients.

"The FDA's reported decision will likely pose significant hardships for many patients and delay relief for vulnerable patients with legitimate chronic pain, especially those in nursing home and long-term care," said Kevin Schweers, a spokesman for the National Community Pharmacists Association.

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I have a couple friends who work at a pharmacy and they say many of the vicodin users die after a period of use, all of the same things, stroke, gastrointestinal complications/cancer. go figure, first week taking them and your pooper stops.  no thanks, I'll just dig my herb, I heard nobody's died from that, ever in history, except in prisons, raids, and prison raids.

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i'm curious what the fda is going to give people who have pain after they lock up all the pills.

 

its not like removing the pills removes the pain.

people are still going to be in pain.

 

i guess theres going to be an upswing in suicides. unless marijuana can be legalized in more states.

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Not a good plan it will hurt a lot of patients who need the pain meds. Doctors have created this mess they have written Rxs for patients in a lot of cases because it was the easy way out. Its often easier to get narcs than antibiotics! I have put more than a few years in nursing homes as a nurse,and a great deal of narcotic abuse occurs in the elderly. Doctors don't spend the time to find the root cause of the pain - and they get tired of the whining so they whip out the ol Rx pad. You would be astounded to see the kinds and amounts of narcotics prescribed to the elderly. Ive seen 90 lb 80 year olds on Fentanyl patches 100meq Vicodin 750s every 4 hrs Ativan three times a day and various sleeping pills - thid snf eorse is the norm!. Most of the addicts are seniors believe it or not. And we wonder why they fall or cant remember crap. Metadone and oxy are regularly prescribed in astonishing doses for years and years. These patients cant write their on Rxs - the doctors are the dealers! Yet every time they add more restrictions on Narcs it seems the patients who are in real need have a hard time getting their pain control needs met - the non chronic complainers don't get the same drugs the chronic malingerers get.

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  • 4 weeks later...

By early December, FDA plans to submit our formal recommendation package to HHS to reclassify hydrocodone combination products into Schedule II. We anticipate that the National Institute on Drug Abuse (NIDA) will concur with our recommendation. This will begin a process that will lead to a final decision by the DEA on the appropriate scheduling of these products.

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"....If the drug is reclassified to Schedule II, patients will only be able to receive one 90-day prescription, similar to drugs like OxyContin. The drug could also not be prescribed by nurses and physician assistants...."

 

I wonder if this is true? And if it is, how does it fit into SB660 proposed 1 year card use for mmj under sch 2?

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none eh? no bias there ?  surely you are not hydrocodone defiecient. Vicodin is not for long term use, and after 12 years, not to mention the myriad of other complications that you wouldn't deny, a few days after stopping the drug maybe

 

be safe

 

Honestly, without knowing me or my medical history, I don't think you can make that assessment.  ....and no, I have had no long term adverse effects.  I went to the pain-killers when MMJ could no longer keep up with my pain.  I have pancreatitis, and four herniated discs as well as having broken my back.  If it was just the back pain, I could probably get by on MMJ alone.  Pancreatic pain is a different ball game.  If you haven't experienced it, I cannot accurately describe it for you.  It oftens feels as though I have a fence post going through my chest, and even that's an understatement.

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I meant no judgment here.  I don't have to know you to know that you are not vicodin deficient, and they only mask symptoms, and are not for long term use.

 

I have only one relative with pancreatitis, and he died last year, of a morphine overdose. He used that, after vicodin  became brutal to his digestive system. He saw morphine as his lifeline, until it wasn't anymore. Hospice helped that along, in one evening, bless them, he'd say.

Honestly, without knowing me or my medical history, I don't think you can make that assessment.  ....and no, I have had no long term adverse effects.  I went to the pain-killers when MMJ could no longer keep up with my pain.  I have pancreatitis, and four herniated discs as well as having broken my back.  If it was just the back pain, I could probably get by on MMJ alone.  Pancreatic pain is a different ball game.  If you haven't experienced it, I cannot accurately describe it for you.  It oftens feels as though I have a fence post going through my chest, and even that's an understatement.

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folks suffering here in this state are not even statistically registering for medical marijuana relief. less than 3% . Its not difficult to be qualified with a cancer diagnosis, yet less than a percent of those registered too. not sure legalization is the answer to pain relief. but it sure might help the access.  where are the cancer victims? where are the 63% of the supporters, when the majority of them suffer from debilitating pain also. makes no sense to me.  on paper people have cast their votes with oxycontin use in MI, not medical marijuana

i'm curious what the fda is going to give people who have pain after they lock up all the pills.

 

its not like removing the pills removes the pain.

people are still going to be in pain.

 

i guess theres going to be an upswing in suicides. unless marijuana can be legalized in more states.

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I've been taking hydrocodone for over 12 years with no adverse side effects.

Lucky you I was hooked on 2 750 mg a day for 4 years finally switched to cannabis because of the with drawl dope sick feeling which I still get to this day my stomach is destroyed because of the aspirin in the pills now I am  dealing with chronic stomach pain from the years of use.

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I am glad you survived the 4 years of hell ! kudos for cannabis !  I hope that stomach heals up for you.

Lucky you I was hooked on 2 750 mg a day for 4 years finally switched to cannabis because of the with drawl dope sick feeling which I still get to this day my stomach is destroyed because of the aspirin in the pills now I am  dealing with chronic stomach pain from the years of use.

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Lucky you I was hooked on 2 750 mg a day for 4 years finally switched to cannabis because of the with drawl dope sick feeling which I still get to this day my stomach is destroyed because of the aspirin in the pills now I am  dealing with chronic stomach pain from the years of use.

 

KD chances are there was some real damage done to your stomach from this period. Hope that you are following up with some help from the medical profession.

 

My brother reluctantly had to have 3/4 of his stomach removed recently. [4/2013] The years of drinking and improper diet finally took its toll.  He's very lucky he got the much needed care in the nick of time.  Partly because I wouldn't foot the bill for his antacid pills, [knowing my sister had sent him some cash] he tried to tuff it out. Finally he had to call an ambulance...   

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Acetamenaphine,Tylenol causes pancreatitis and kills your liver. Why have you been on it so long,and why does your Dr keep RXing it for you? Opiates rip your guts to shreds. I know. I have had gut disease my whole life. And now I have NO guts. You are on your way to an ostomy or a gut bleed that will kill you. Have you tried epidurals yet? Pretty much the last option,but still an option. Opiates turned on me,and now I cannot take any kind of pain meds. It's slow torture and makes you want to kill yourself.

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