FDA Recommends Hydrocodone Restriction to Schedule II

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FDA recommended stricter controls on hydrocodone medications on October 24th.  It is expected the DEA will concur.  Many people know them by name (Vicodin, Vicodin ES, Anexsia, Lortab, Lorcet, Lorcet Plus, Norco, Zydone).  In a move by the FDA that many people hoped would not happen, people with chronic pain have been dealt a strong blow.  In January 2013, an advisory panel of experts to the Food and Drug Administration FDA Safety and Risk Management Advisory Committee article voted to toughen the restrictions on painkillers like Vicodin that contain hydrocodone, the most widely prescribed drugs in the country.  Significant increase in pain research to discover better and more appropriate treatments would balance the unfair burden this decision makes on people with chronic pain conditions.  Congress, NIH, and the FDA cannot turn their backs on 100+ million people with chronic pain conditions.  Increased effort to address addiction and abuse of medications containing opioids is needed as well as significantly more research to find appropriate and effective chronic pain treatments.

Rescheduling hydrocodones from Schedule III to Schedule II will have sweeping consequences for doctors, pharmacists and patients. Refills without a new prescription would be forbidden, as would faxed prescriptions and those called in by phone. Only written prescriptions from a doctor would be allowed. Distributors would be required to store the drugs in special vaults.

In preparation for this possible change, the National Fibromyalgia & Chronic Pain Association created the "National Pain Medication Survey" on Survey Monkey and sent out notices to more than 100,000 people with FM and/or chronic pain. Almost 6,000 people clicked onto the survey and more than 800 people completed it, meaning almost 13% of people had a pharmacist refuse to fill their prescription for an opioid medication.  If a participant was not taking opioid medications at the time of the survey, they could only fill out a portion of the questionnaire. Currently, a draft of the survey analysis is being completed with the intention to publish the  final results.  Statistics revealed that a stunning number of people have contemplated suicide without access to pain medication for pain relief.  The NFMCPA will notify their constituents when the completed analysis is published. 

If you were one of the many people who took the time to take this survey, the NFMCPA thanks you. The published results will help medical professionals, the FDA, and the DEA better understand the extent of problems surrounding denial of adequate pain relief for people who are suffering. 

To read the complete notice on the recommendation to reschedule hydrocodones on the Federal Register, click here.