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Concerns about generic painkillers increase
December 14th, 2012
11:21 AM ET

Concerns about generic painkillers increase

The White House Office of National Drug Control Policy recently sent an alert to law enforcement, particularly along the Canadian border, warning them that Canada had approved non-abuse resistant generic versions of oxycodone, the active ingredient in OxyContin, Percocet and about 40 other painkillers.

"ONDCP expects companies will begin offering these generics without the abuse-resistant features in Canadian pharmacies within the next month," according to the alert.

The letter warned of the potential for these generics to show up here in the United States, where they are no longer available.

Prescription painkillers have killed more Americans than heroin and cocaine combined. That's according to the Centers for Disease Control and Prevention (CDC), which says the United States is in the throes of a public health epidemic fueled by highly addictive prescription painkiller overdoses.

Approximately 12 million Americans aged 12 and older reported using prescription painkillers recreationally in 2010, according to the CDC. In fact, enough were prescribed to medicate every American adult around the clock for a month.

Deaths have skyrocketed during the past decade. In 2009, about a half a million people visited emergency rooms as a result of abusing or misusing prescription opioids like Vicodin (hydrocodone); OxyContin (oxycodone), Opana (oxymorphone) and methadone, the CDC found.

The drugs were attractive to abusers who would crush them to snort or melt and then inject them. Oxycontin had a time-release formula that delivered the drug over a 12 hour period. But when crushed, the entire dose was immediately absorbed into the bloodstream.

Pharmaceutical companies like Purdue Pharma, maker of Oxycontin, and Endo Health Solutions, which makes Opana, support efforts to reduce abuse. In 2010 Purdue pulled the original Oxycontin off the shelf in the United States and Canada and reformulated the pills, making them crush-resistant. Opana was also reformulated.

In the early months of 2013, generic versions of two of these pain killers - Opana and Oxycontin - could become available.

While the much-talked-about fiscal cliff could have dire consequences, they are "not as grave as the consequences of inaction over the next three  weeks on this issue of powerful pain relievers coming to market without abuse-deterrent features," said Michael Barnes, executive director of the Center for Lawful Access and Abuse deterrents, or CLADD.

"This issue is a life or death matter. Without congressional action between now and December 31st, kids will die from overdose. That's much worse than the economic consequences of tax increases and spending cuts. Congress has to act."

Barnes supports the STOPP Act, Stop Tampering of Prescription Pills, a bill introduced in Congress this summer by Rep. Bill Keating, D- Massachusetts, and Rep. Hal Rogers, R-Kentucky.  STOPP would give the FDA authority to require medications with oxycodone and hydrocodone be made tamper-resistant.

"We have the ability to prevent deaths and that's what makes this issue so compelling," Keating told CNN. "Its not a theory. It's not research. We're urging the FDA to take action and show leadership. Canada has made their decision on how to deal with it. I think if we make a decision to go with tamper-resist requirements it's going to pressure them to do the same thing."

"The impacts of these generics would not only be downright disastrous for the law enforcement and health communities, but would also jeopardize the costly, painstaking gains we're already made in our fight against this scourge – shutting down pain clinics, sending rogue doctors to jail, and standing up interoperable state-based Rx monitoring." Rogers said in an opinion piece last month. "FDA must use its power to prevent these crushable generics from turning up in the hands of children."

Pharma recently released a statement saying they support passage of STOPP.  They've called on the FDA to issue guidance to manufacturers on the use of abuse-deterrent technologies in opioids now in development or under FDA review, saying in part, "unless FDA rules on these petitions soon we believe that non-abuse-deterrent or non-tamper-resistant generic versions of those products will be able to come to market under current FDA processes for approval of generic products."

FDA spokeswoman Morgan Liscinsky told CNN she could not comment on the issue because of a pending lawsuit by Endo to block approval of the generics as well as a number of citizen petitions.

"The FDA understands how important it is to give guidance and appropriate support regarding the development of abuse-deterrent formulations of opioids and also recognizes the important role that generic drugs play in our healthcare system," Linscinsky said. "As an example of our ongoing work, the agency is currently in the process of developing a guidance on the issue of abuse deterrent formulations."

The agency expects to have a draft completed early next year.


soundoff (16 Responses)
  1. Fbks68

    Stupid article. Why care what Canada does. It is a sovereign country. Not part of the U.S.

    December 14, 2012 at 18:49 | Report abuse | Reply
  2. drain cleaning CO

    I like the part where you say you are doing this to give back but I would assume by all the comments that this is working for you as well.Thanks
    drain cleaning CO

    December 15, 2012 at 03:18 | Report abuse | Reply
  3. lamarieblabla

    @Fbks68
    Even though Canada and the US are, indeed, different countries, they do share a 5500 miles border (plus a 1500 miles border between Alaska and the Yukon), thus making it quite easy to buy the drugs in Canada and smuggle them into the US...

    December 15, 2012 at 09:29 | Report abuse | Reply
  4. julie

    i dont get why people r on pain pills for so long its easier to keep them dope up then to get the real help that they need and who profits from it all no one gets better just more high

    December 15, 2012 at 11:57 | Report abuse | Reply
  5. Mark

    One of the most effective painkillers, THC, is outlawed in the US. It is not physically addictive and cannot cause a fatality.

    December 15, 2012 at 15:09 | Report abuse | Reply
  6. empresstrudy

    A better approach would be to flood the country with these and allow it to become a self correcting problem in the end. So what if they all kill themselves. It's not as if 'the war on drugs" has any hope or chance of success. Screw it.

    December 17, 2012 at 10:49 | Report abuse | Reply
  7. RealGlaird

    Stupid article because it completely ignores the 800 lb. gorilla in the room; the patient in severe chronic pain.
    My wish is that the author of this inflammatory article, gets to experience first hand, the hopelessness of severe chronic pain. And, have someone just like themselves, to try and go to for help.

    December 17, 2012 at 12:33 | Report abuse | Reply
  8. Redclay

    I've had to live with daily painkillers for the last 11 yrs b/c of fibromyalgia & back & neck pain. I'm one of the estimated 50-80 million Americans who need pain med to function a halfway normal life. I can understand the need to guard against abuse uses, but I hope that they don't make it harder for us pain-sufferers to get the prescribed med's we need.

    December 17, 2012 at 17:37 | Report abuse | Reply
    • Chana

      Well said. I work as a nurse in Canada, with people who are in end stage cancer. You are right, some people actually need these medication and do not abuse them. I also hope that they realize this.
      I wish you well.

      December 17, 2012 at 23:36 | Report abuse |
    • Fiona

      Redclay, I have lived with severe spinal pain and chronic migraines for my entire, long life. There are other and better ways to deal with pain than addictive drugs. Exercise, weight loss, proper nutrition, herbal supplements, acupuncture, therapeutic massage (by a licensed therapist with separate physical therapy training...not talking about a "spa massage"), physical therapy, and - in my case - yoga all help to manage the pain and heal the body. All an opiate does is mask the pain. It's the easy way out.

      End-stage cancer patients are a different matter. I've lost several family members to cancer, and morphine eased their last days.

      December 24, 2012 at 15:16 | Report abuse |
  9. Fiona

    I had a reaction to prescribed oxycodone (prescribed by an ER doc for an injury) that was so severe I was screaming in pain, and projectile vomiting. That stuff is poison.

    December 24, 2012 at 15:08 | Report abuse | Reply
  10. المسالك البولية وسلس البول

    I hate to take any type of medicine.

    December 26, 2012 at 03:36 | Report abuse | Reply
  11. MikeH

    Ok......why don't the healthcare community REALLY put forth an effort to get people better? Then they would not NEED the pills. Oh wait...way to much money going on under the table.

    January 26, 2013 at 02:10 | Report abuse | Reply
  12. openmined69

    @ Fiona, do you have Fibromyalgia?...If not, then you cannot come close to understanding those of us who do suffer from it. and yes, I did everything you listed...plus more for years before having to start with the pain-meds. Yes, your list still helps with some of the symptoms, but there are so many different things to deal with each and every day. Most people who have Fibro, have no quality of life. its hard when you cannot go on vacations, or even taking a shower is very painful at times. the worst for me is the fact that I hardly "EVER" have a day I can spend with my grandchildren without pain somewhere constantly in my body. and I am here to tell you from my experience, the pain meds, only mask the pain and never do they completely stop it. But, it seems like when a doctor can get you on something that gives you some comfort,the government steps in and takes controls. .."ITS ALL ABOUT THE MONEY" I could go on and on, but will not. I can only pray for anyone who is affected by anything medically and pray for those who are lucky enough to be healthy. God Bless to all...

    March 20, 2013 at 19:24 | Report abuse | Reply
  13. cecile

    I've been on long acting oxy for over 8 years. Before that..I had no life. Oxy gave me back my life..though I'm still in pain..it is tolerable because of the meds. I have "complex regional pain syndrome" as a result of a doctor leaving behind a piece of gauze when I had bi-lateral mastectomies for ductal carcinoma. It took 7 months and 13 surgeries to clear up the mess they had made. I've been in pain ever since. That was 12 years ago. For 4 years I just suffered in silence...my life was falling apart. I'm very grateful to have drugs like oxy available. It's unfortunate that a few who abuse the drug can end up ruining it for those of us who do need the drug...and who do not abuse it. And BTW of the deaths caused by prescription drugs...Oxy is not even on the top of the list. Drugs used to lower cholestrol are far more dangerous...so are anti depressents. ok..I'm done my rant.

    April 6, 2013 at 02:03 | Report abuse | Reply
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