The Food and Drug Administration took an important step last week to curb an epidemic of overdose deaths from misuse of prescription painkillers that contain hydrocodone, such as Vicodin, Lortab and their generic equivalents, in combination with another painkilling drug. The only regret is that it took so long for the agency to make up its mind.
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The federal Drug Enforcement Administration first asked that the F.D.A. conduct a review to tighten restrictions on the painkillers in 2004 by changing the drugs from Schedule III, where restrictions on prescribing and using the drugs are only moderate, to Schedule II, where they are much more stringent.
But the F.D.A. resisted that change, until it reversed course on Thursday and announced that it would recommend that products containing hydrocodone be reclassified into Schedule II, which governs more powerful painkillers like OxyContin. The change is likely to go into effect in 2014.
The new regulations apply to combination pills that include hydrocodone along with a nonaddictive painkiller such as acetaminophen or aspirin. The rules would limit patients to a 90-day supply of the combination drug and would require patients to visit a doctor for a new prescription and to take a prescription to a pharmacy rather than have a doctor call it in. The regulations for Schedule II drugs also impose tight storage and record-keeping requirements on pharmacies.
Some doctors and patient groups are complaining that the change will make it harder for some patients to get the medicine they need. But the F.D.A. has struck a reasonable balance between patient access and restricting drugs that have contributed to an upsurge in overdose deaths and addictions.
On Friday, however, the agency announced a troubling decision to approve a pure hydrocodone drug without the protections that many experts deem necessary. It is a new medication (not combined with an analgesic such as acetaminophen) for extended relief for chronic pain. The drug is known as Zohydro ER, made by Zogenix, a specialty pharmaceutical company. It will be a Schedule II drug subject to the tight restrictions in that category.
The concern raised by critics is that patients might overdose on the high-potency opioid drug, either deliberately or accidentally, because it is not formulated in a way to deter abuse. An expert panel that advises the F.D.A. voted 11 to 2 against approval in December because panel members said that before approving this drug or any more like it, the products should be made more resistant to abuse or tampering and the current rules on monitoring of doctors and pharmacists and educating health professionals on how to prescribe them safely should be strengthened.
F.D.A. officials contend that the technology of abuse-resistance is in its infancy and cannot be applied to all products. They are requiring the manufacturer to conduct postmarketing studies of the amount of misuse, abuse and addiction associated with the drug. But that approach may not be enough to protect patients from potential harm.
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