Advocacy Group Warns FDA on New Hydrocodone Formulations

Chicago, IL, February 03, 2012 --(PR.com)-- A consumer advocacy group has warned the FDA that new single entity, extended-release (ER) formulations of the opioid painkiller hydrocodone could bring on the next tidal wave of overdose deaths and addictions if approved by the agency. Advocates for the Reform of Prescription Opioids, Inc. (ARPO), a nonprofit organization dedicated to ending the epidemic of death and addiction caused by the oversupply of prescription opioid drugs, is deeply concerned that several different drug companies are reportedly testing new formulations which contain much higher doses of hydrocodone than most current products on the market, including such well-known narcotic painkillers as Vicodin, Norco and Lortab.

ARPO has major reservations about the development of a “pure” ER form of hydrocodone. Vicodin was recently rated as the third most dangerous prescription drug in America (Gray 2012) based upon data on emergency room visits and has been implicated in the deaths of thousands of Americans each year (Florida Department of Law Enforcement 2006-2010) despite containing a relatively low dose of hydrocodone (5 mg). Because ER formulations are designed to enable the pain patient to take their opioid medication less frequently (once every twelve hours), the pills contain considerably more of the active ingredient (dosages between 10 and 50 mg are reportedly being tested). OxyContin, a notorious drug that has been at the center of an epidemic of prescription opioid death and addiction due to overprescribing and diversion, is a similar formulation. It is the popularity of hydrocodone combined with the increased dosages that concerns ARPO. “Approval of extended-release hydrocodone will lead to a surge in prescription drug deaths,” said Pete Jackson, President of ARPO who lost his daughter to a single OxyContin pill in 2006. “This could be the next OxyContin.”

Since the late 1990s prescription opioid sales have risen dramatically, a trend that has been paralleled by a marked rise in the number of deaths and addictions from these drugs (CDC 2011). The Centers for Disease Control (CDC) reports a four-fold increase in deaths to around 15,000 annually from prescription opioids to go along with a six-fold increase in addiction treatment over the past decade (CDC 2012). "The FDA and other government agencies have been unable to stop the soaring increase in deaths from prescription opioids because they have failed to implement policies that would reign in the relentlessly escalating sale of opioid painkillers. It makes absolutely no sense to continue approving narcotic drugs for sale in this country while a public health crisis that the Obama Administration has called ‘an epidemic’ continues to worsen. FDA should take a hard look at the lessons learned from OxyContin and not accept any applications for the new extended-release hydrocodone formulations. There are already multiple available treatments for pain. Let’s address the ongoing epidemic without throwing more fuel on the fire,” said Jackson.

Said Jackson, “Our government agencies, working with the medical profession, must fix what is wrong with the current opioid crisis before considering additional products that will offer more of the same risks without any demonstrable benefits over currently available opioid formulations. FDA needs to send a strong signal to the pharmaceutical industry that it will not entertain any NDAs for an extended-release formulation of pure hydrocodone.”

References:
CDC 2011. Vital Signs: Prescription Painkiller Overdoses in the U.S.
http://www.cdc.gov/vitalsigns/PainkillerOverdoses/index.html also see
CDC's Morbidity and Mortality Weekly Report, November 4, 2011:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6043a4.htm?s_cid=mm6043a4_w

CDC 2012. Policy Impact: Prescription Painkiller Overdoses. http://www.cdc.gov/homeandrecreationalsafety/rxbrief/

Florida Department of Law Enforcement. 2007-2011. Drugs identified in deceased persons by Florida Medical Examiners. Most recent report is for 2010: http://www.fdle.state.fl.us/Content/getdoc/9256e6e4-67bf-4a02-a7c6-3f1e93fde6c1/2010DrugReport.aspx

Gray, Kevin. 2012. The 10 most dangerous meds driving America’s pill crisis. AlterNet Personal Health, The Fix. http://www.alternet.org/health/153576

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Advocates for the Reform of Prescription Opioids, Inc. is a bi-national, nonprofit consumer advocacy organization operating in the U.S. and Canada. For more information, please visit www.rxreform.org.

Contact: Pete Jackson
(847)-577-4438 evening
(312)-886-3894 daytime