FDA Proposes Tighter Controls on Addictive Painkillers

Soaring rates of prescription drug abuse are driving the agency's move

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Vicodin is prescribed to treat chronic pain, which affects 20% to 30% of adults and is twice as common in women as in men.

The FDA is pushing for new limits on drugs containing hydrocodone, a highly-addictive painkiller present in Vicodin and some of the most widely- prescribed medicines in the country. In 2011, U.S. doctors wrote over 131 million prescriptions for drugs containing the opioid.

The agency said in an online statement Thursday that hydrocodone should be regulated to the same extent as other narcotic drugs like oxycodone and morphine. The new restrictions would prevent doctors from prescribing more than a 90-day supply of painkillers, patients would not be able to get refills without a doctor’s visit, and prescriptions could no longer be phoned into to pharmacies. What’s more, according to the Associated Press, the drugs could not be prescribed by nurses or physician assistants.

Prescription painkiller overdoses result in around 15,000 deaths per year — more than cocaine and heroine combined. The DEA has long recommended tougher restrictions on hydrocodone, and wants drugs containing hydrocodone to be reclassified as Schedule II, which are the the most strictly regulated legal drugs. The Drug Enforcement Agency defines a Schedule II drug as one with “a high potential for abuse” and “potentially leading to severe psychological or physical dependence.”

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

But studies show that the majority of people who abuse painkillers don’t even have a prescription. Instead, most hydrocodone abusers get the drug from a friend with a prescription. Of all the fatal overdoses in West Virginia — where abuse of the drugs is particularly prevalent — only 44% had prescriptions.

Some worry that the new restrictions would make it harder for those who legitimately rely on the drugs to treat chronic pain  — such as those with fibromyalga and multiple sclerosis — to obtain them. As TIME’s Maia Szalavitz noted earlier this year, “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.” What’s more, those who live in rural areas who do not have regular access to a doctor might wind up going months without needed medication.

Once the DEA approves the recommended reclassification, the FDA’s recommendations could go into effect as early as next year.


Correction: The original version of this post misspelled the name of the chemical hydrocodone


I understand from another article in Time that 47 million patients get prescriptions for this drug every year. There are 15,000 deaths each year from OD or improper use of this drug. That 44% of that 15,000 don't even have a prescription for the drug. That leaves 8400 people who get prescriptions every year die most as a result of illegal use of the drug. So the solution to the problem is to inconvenience 46,985,000 patients, their doctors, their caregivers, and their pharmacies to try and prevent these unfortunate deaths. Think of the added costs to millions of suffering people who's only sin is to be inflicted with some disease that can't be cured.  Would not that money be better spent on well designed easily accessible mental health, and drug treatment programs? You give no comparison of the drugs being prescribed as a substitute. How many people OD or die from misuse of these drugs? Did you subtract from the 8500 deaths for a comparison? Are the side effects of the replacement drugs more dangerous? Costs higher? Will pain patients suicide rates go up due to poor pain management? We may be jumping from the pot to the frying pan with this solution. Medicine should use good data to make decisions.  I feel for the families who loose someone to drug abuse. I would gladly agree to some tax to help pay for proper treatments, or to use the savings from eliminating all the expensive regulations on the legal users to help pay for treatment programs. I also feel for those 47 million people in pain. This will only bring more humiliation and suffering to them, and unfortunately nothing in the article shows it will fix the problem. 



 I absolutely concur with your point. Since the point you make is so obvious I have been trying to figure out what is the real problem? Surely the pharmaceutical companies don't mind making the extra money.( By the way opiates are not that expensive to make.) Most overdoses are a combo use problem not just someone taking a 7.5 vicodin for chronic pain as prescribed. I worked as a detox nurse for 10 years and the average person who I detoxed off of narcotics were not on any kind of dose the average person could obtain. How about 30 vicodins a day or 15-20 percocets! The average abuser was on a high dose way above the average prescribed dose from pain clinics. Thus involving street acquiring and illegal gains. This is not who is going to be affected by this ban on narcotics. It will be the poor woman in a nursing home who has to wait 24 hours for a single v icodin to help offset the pain of her fall. It will be the person in the dentist with a cracked tooth who is told to take motrin until it can be repaired.

 It seems like America wants the rebels because it always sets laws to attack the good people, the ones trying to live right and work hard. Its like gun control, soon only criminals have the guns. Prohibition never worked. The minute you start controlling and regulating is the minute you create a counter revolution for people to obtain what they want, then only the weak and truly infirmed suffer.