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

Stricter rules for prescribing opioids may not be the only answer to curbing addiction to painkillers

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Vicodin tablet

(UPDATED) Last week, 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

As part of the FDA’s two-day hearing on the reclassification, pain patients and their families submitted poignant testimony pleading with the agency to not construct more hurdles to receiving proper pain care.  One man wrote of his wife:

She is in excruciating pain every minute of every day of her life for the past twenty years. [The pain was caused] by a butcher of a doctor who drilled a pin through her radial nerve during a routine operation to fix a broken wrist. He left the pin in, despite her pleading of pain for six weeks. To take the pain pills away from her would lead to her death from suicide because the pain would be unbearable.

Another chronic pain patient wrote, “[W]ithout the medicine I am being prescribed, I would not be able to work and would end up on disability. A third pleaded simply, “Nonono. This does not help all of us who deal with chronic pain. I am sick and tied of addicts screwing up MY health care. Find another way!”

Finding another way, is, unfortunately, exactly what addicts tend to do when faced with these kinds of barriers, which may lead them to take more dangerous illegal substances. A recent letter in the New England Journal of Medicine found that when a substance was added to Oxycontin to deter abuse, only 13% of prescription drug abusers continued to rely on the drug as a primary high, down from 36%. Heroin use among them, however, doubled.

And some who opposed the changes noted in testimony to the FDA panel that Oxycontin, a stronger painkiller containing oxycodone, which is similar to morphine, has always been subject to the stricter Schedule II prescribing rules, yet it is widely abused and credited with launching the opioid prescription drug epidemic. While we don’t know what effect the new restrictions will have, we do know that the changes alone won’t address the reasons why some people seek opioids in the first place.  Chronic pain patients should not have to suffer to fight other people’s addictions.

MORE: Government Considers Overdose Antidote, Naloxone, to Fight Prescription Drug Misuse

*Updated to include quote from Kolodny on PROP’s intent.