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28-01-2013 | Article

FDA panel majority views a need for hydrocodone restraint


Meeting information

medwireNews: A majority of members on a Food and Drug Administration (FDA) advisory committee voted for stricter regulation on painkillers after a 2-day discussion about the public health benefits and risks, such as the potential for abuse, of drugs containing hydrocodone.

The panel voted 19-10 to reclassify hydrocodone combination painkillers - a policy change that has yet to be approved by the FDA. If the policy amendment were to be accepted, it would significantly curtail doctors' ability to prescribe the drug with the hope of stemming the current, rampant addiction to painkillers that began in the late 1990's.

The advisory meeting took place in Silver Spring, Maryland, and was ultimately set in motion by a Drug Enforcement Administration request to the Department of Health and Human Services to conduct a scientific and medical evaluation that would guide recommendations to address accruing reports of misuse, abuse, and addiction.

"We've seen the terribly serious consequences of poor prescribing practices stemming from obvious misclassification of hydrocodone combinations," said panelist Mary Ellen Olbrisch (Virginia Commonwealth University, Richmond, Virginia) at the meeting.

Specifically, the vote could change hydrocodone's current Schedules ranking from 3 to 2, which pertains to prescription drugs that contain a controlled substance, and would consequently lessen the number of prescribers who can sign off on patients getting the drug.

Numerous opponents to the change thought it would be fruitless in ridding abuse. Some painkillers, such as oxycodone, are in a more restrictive category yet are still highly abused, they said at the meeting.

Advocates for nursing home patients and representatives from groups such as the American Academy of Pain Management expressed concern about how regulatory changes would affect access to painkillers, pointing out the obstacles that chronic pain patients would suffer if refills requiring new prescriptions were no longer attainable via fax or phone. The rule change would also disallow nurse practitioners and physician assistants from prescribing this type of drug, which they warned would inconvenience patients who reside in underserved rural areas - and legitimate patients altogether.

Currently, painkillers cause more death in the USA than heroin and cocaine combined. A 2010 Centers for Disease Control and Prevention report noted a parallel between a jump in overdose deaths and a 300% increase in prescription painkiller sales.

By Peter Sergo, medwireNews Reporter