Critics are calling out to the U.S. Food and Drug Administration (FDA) to reverse its approval to the new narcotic painkiller, Zohydro ER as it could be addicting and abused.
FDA has approved the use of Zohydro ER (hydrocodone bitartrate extended-release) capsules for the treatment of severe pain in October 2013 for patients suffering from pain that is severe enough to require a continuing daily, round-the-clock treatment or when alternative treatment options are unavailable or inadequate.
The painkiller, which is the first FDA-approved single-entity and extended-release hydrocodone product, is categorized as a Schedule II controlled substance under the Controlled Substances Act. Single-entity means it is not used in combination with an analgesic like acetaminophen.
However, weeks before its scheduled release in the market on March, individuals and organizations, including attorneys general from 28 states and addiction treatment providers, appealed to FDA commissioner Margaret Hamburg, M.D., to stop it.
They believe that the drug could become abused and misused just like OxyContin -- an opioid used to manage severe ongoing pain, such as pain brought by cancer.
Andrew Kolodny, M.D., co-founder of the support group Physicians for Responsible Opioid Prescribing, told WebMD that this new painkiller will be available in doses as high as 50 mg per capsule -- a preparation five times higher that the immediate-release hydrocodone capsule. Even if it is meant to be released little by little over 12 hours, the drug could still be tampered with to release a large dose at once.
Opioids have similar properties to the opium. It is a synthetic narcotic pain medication that suppresses the central nervous system, relieves pain, and induces sleep. It can bring grave adverse effects if not taken properly.
"I firmly believe that the benefits of this product outweigh its risks," said Bob Rappaport, M.D., division director at FDA's Division of Anesthesia, Analgesia, and Addiction Products, to WebMD. "Many patients in the U.S. suffer from untreated or poorly treated chronic pain. Further limiting access to potential treatments is not the answer when new treatments are critically needed."
