FDA Action on Vicodin May Mean More Pain, Not Less Addiction or Overdose

Posted: May 22, 2013 in Uncategorized


A Food and Drug Administration (FDA) advisory panel voted to impose stricter controls on prescriptions for drugs like Vicodin, which contain the opioid pain reliever hydrocodone.  The new rules would ban prescribing of more than a month’s supply of hydrocodone-containing drugs and prevent refills without a new doctor visit. Prescriptions would not be allowed to be phoned, faxed or emailed and physician’s assistants and nurse practitioners wouldn’t be permitted to prescribe the medications in the states in which they have limited prescribing powers.

Citing growing concern about prescription drug misuse and the potential for addiction to painkillers — overdoses lead to 15,000 deaths annually — the Drug Enforcement Administration (DEA) has long pushed for the stringent rules, which would reclassify opioid pain relievers as Schedule II drugs, the most restricted category short of being prohibited. The FDA is likely to accept the panel’s decision, changing the rules for some 47 million patients who receive prescriptions for hydrocodone-containing products annually.

“I believe that this change will mark a turning point in the epidemic,” Dr. Andrew Kolodny, the founder of a group called Physicians for Responsible Opioid Prescribing (PROP), told NPR. “It will lead to less people becoming addicted, which is the most important thing that needs to happen to bring this crisis under control.”  PROP has petitioned the FDA to tighten the official labeling on opioids, which critics say would result in even more severe restrictions.  But Kolodny says that their intent has been “misinterpreted” and they do not want to see legitimate access reduced.*

However, according to numerous studies and government statistics the majority of those who become addicted to opioids don’t get hooked after receiving legitimate prescriptions from doctors for pain treatment. More than two-thirds of people who used opioids  recreationally in 2010-2011 obtained the medications from friends or relatives for free, mostly with their permission.  And, of people in treatment for chronic pain without a prior history of drug problems, a Cochrane review found that less than 1% became addicted to the medication, with 44% dropping out of treatment due to side effects from the drugs.

Similarly, most fatal overdoses do not seem to involve people taking their medications as prescribed for pain — one study in hard-hit West Virginia analyzed medical examiner records and drug treatment data and found that 95% of victims had signs of addiction, such as snorting or injecting drugs meant to be taken orally and combining these prescriptions with illegal drugs.  Only 44% had a prescription that was written for them.  Another study, in Utah, relied on family member reports and found that more than half of victims had misused the drugs.  Since most opioid overdose deaths actually involve mixtures of drugs— typically including alcohol, which patients are warned not to drink — misuse significantly increases the risk of dying from abusing the medications.

The new rules would likely make it harder for those who rely on opioids to treat chronic pain for conditions like multiple sclerosis, fibromyalgia, certain genetic disorders and some severe injuries (the kind of pain that often lasts decades) to get their prescriptions filled. Many doctors already decline to treat chronic pain with opioids, fearing prosecution if some of their patients turn out to be addicted to the painkillers and are faking pain, or end up overdosing.  Those who can get treatment are already subjected to random pill counts and urine tests to ensure they are taking their pills as directed and as needed.

Under the new rules, some patients may even lose access to treatment entirely because insurers may not cover the monthly doctor visits required for continued prescribing or because doctors may not want to deal with the added hassle. Many pharmacies also refuse to carry Schedule II drugs. Nursing homes already report problems with other opioid drugs in Schedule II, as patients are forced to wait for pain relief for an unavailable physician to update a prescription. And, with non-physicians in rural areas unable to prescribe, patients may be switched to weaker and less effective drugs in Schedule III.

But the restrictions likely won’t have a drastic change on the number of prescriptions for those with acute pain that ends shortly after procedures like routine surgeries and root canals. And some data suggests that these pills are a source of considerable misuse: because these conditions resolve quickly, many patients won’t finish an entire prescription but will keep the remaining pills “just in case,” making them potentially available to teens or others at risk for addiction.

MORE: Dentists, Too, Can Help Battle Painkiller Addiction

  1. I think if our Govt would fight to get illigal drugs from entering our country from Mexico where the drug problem started then there would not be as bad of a drug problem from prescription drugs in our country.
    There are actually people in our country that are actually suffering from pain and the ones deciding on what they can or cannot take are healthy people with no idea what real pain is. I may be wrong but all the drug addicts that kill themselves has had a problem before prescription drugs were ever introduced.
    Really makes sense that 55 million people that suffer from pain in our country will have to suffer more just to save a few thousand junky lives that will find another way to kill themselves with some sort of illigal drugs. And to think about it, these are mostly lawyers making thes decisions.

    • wesley swift says:

      I agree, But not entirely. Its a big money maker for everyone, Including for the ones that there prescribe too.. I have done roofing my whole life and have a bad back and the doctors gave me pain med’s. And that was fine, But they dident tell me how addictive they were, Of course that was 14 yrs ago too. But there a feel good pill, And who wouldent want to feel good and the pain to stop! but as i was taking them more everyday i thought this isent right.. So when i tried to stop them it was to late.. The prob is today is that you can go to the doc with a ear or tooth ache and the’ll give you pain pill’s. And what i mean about being a money maker, Is that most of the older people that they are prescribed to dont take them b/c they have figured out that they can pay some bills with the extra cash by selling them! When i was on them about 95% of the people i bought them from was over 60 yrs of age.. So there making money, The doctors are making money, The police is, & the biggest one are the pharmaceutical co. I know there are people that is in real pain and needs them, But out of that 55 million about 75% of them dont need them for long term use.. And i did not do drugs before i was addicted to them.. & just remember what if one, Out of that few thousand was your son or daughter. Just sayn.. There’s alot of good people that i know personally that are or have been on them and needed help and could not get it. The same went for me, The doctors have no problem giving them to you, But go ask them to give you something to get off of them and see how far you get. And i agree the ones that are deciding could care less about any of us and they are healthy as a horse! I thank you for your comment and hope to hear from you again. 🙂

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