Food and Drug Administration to examine opioids, chronic pain
The Food and Drug Administration is holding meetings this month and next to consider reclassifying some narcotics and the use of opioids to treat chronic pain.
"These meetings will be used by FDA to inform their decision-making," said Dr. Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing. "If they make the right decisions, it could help bring the epidemic of opioid analgesic addiction and overdose deaths under control."
PROP has filed a petition with the FDA to change the labels on opioid pain medications relating to when opioids are used for non-cancer pain. Kolodny, who is chair of the Department of Psychiatry at Maimonides Medical Center in Brooklyn, N.Y., is asking addiction treatment professionals, researchers, and those who have been harmed by opioids to attend and possibly participate in the upcoming sessions.
"For the past decade, FDA meetings on opioid therapy have been dominated by physician 'thought leaders' who work as spokespersons and consultants for drug companies and by drug company-funded pain organizations," Kolodny wrote in a letter to members. "They have been guiding FDA in the wrong direction and we are all too familiar with the devastating impact this has had. FDA needs to hear from us."
On Jan. 24 and 25 the FDA's Drug Safety and Risk Management Advisory Committee will discuss "the public health benefits and risks, including the potential for abuse, of drugs containing hydrocodone either combined with other analgesics or as an antitussive," according to the agency's website. "Currently, these products are Schedule III drugs under the Controlled Substances Act and Drug Enforcement Administration is considering whether to reschedule the products to Schedule II, which would subject the products to more stringent requirements regarding storage, record keeping, and prescribing, such as limitations on oral prescriptions and refills." The meeting was rescheduled from October because of Hurricane Sandy.
Next month, the FDA plans a public hearing on "diagnosis and understanding of patient pain, understanding and adhering to the labels of pain-treating products, limiting opioid prescriptions and use, and abuse and misuse of opioid medicines."
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February 4, 2013
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