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