News Feature | March 17, 2014

FDA Encouraged To Withdraw Its Approval Of ‘Supercharged' Painkiller

By Liisa Vexler

A number of health care agencies would like the U.S. Food and Drug Administration (FDA) to reconsider its approval of Zohydro, a painkiller described as ‘supercharged’. A petition has been sent to the FDA by 40 watchdog groups and related addiction treatment organizations.

Public Citizen, a consumer advocate group has expressed concern over the strength of the drug, maintaining that it has the ability to kill a child. The drug is being considered too dangerous as a prescription narcotic considering the significant problems of opioid addiction in the U.S. The drug, manufactured by Zogenix and Alkermes pharmaceutical companies’ was approved by the FDA even after negative feedback from the advisory committee. The drug will be available for sale in March of this year and is being described as the first ‘single-ingredient hydrocodone drug’ approved by the FDA. U.S. senators have also voiced opinions over the drug, expressing concern over the proposed management of potential addiction problems. Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing, has stressed that “"too many people have already become addicted to similar opioid medications and too many lives have been lost", in a recent statement for the Public Citizen news release.

There are those in favour of the drug for individuals battling issues of pain management, considering that for many the easing of pain is what allows them to have some fulfilment in life, and that there will always be some that abuse medication. Zogenix is said to be working with a specific group of doctors, experienced in prescribing pain killing medications for patients suffering chronic pain. These measures however are not subduing attempts of opposing groups who worry about future attempts to market the drug for more straight forward pain issues. Prescriptions for narcotic painkillers have spiked in the U.S. in the past few years, as have addiction. The approved release is considered one that may fuel an ‘opioid addiction epidemic’ in months/years to come.

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