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Beyond the Headlines: What the FDA Decisions on Extended-release and Long-Acting Opioids Mean for People With Pain
Date:9/17/2013

CHICAGO, Sept. 17, 2013 /PRNewswire-USNewswire/ -- The physicians of the American Academy of Pain Medicine (AAPM) hailed long-awaited labeling changes and other steps taken by the U.S. Food and Drug Administration (FDA) last week to enhance safety in the prescribing of extended-release and long-acting (ER/LA) opioids. AAPM further supported the Agency's decision to deny portions of a citizen petition seeking dosage and treatment duration limits that would have applied to every patient regardless of individual circumstance. The Academy had previously argued that the proposed limits were arbitrary, lacked scientific substantiation, and could lull prescribers into solely focusing on dose, which could have led to ignoring additional risk factors.

The FDA considered thousands of comments and pieces of scientific literature to reach its recommendations, which were announced last week. Seeking today to provide perspective on what the FDA decisions mean for patient care, AAPM leaders praised the agency's careful, judicious review of the evidence and its move toward advocating individualized therapy.

"These were good moves for people who suffer the most intractable, severe pain and who find alternatives to opioids ineffective," said Lynn R. Webster, MD, president of AAPM. "It is important for us to put the FDA's actions in context and to make sure the clinical implications are understood. Incomplete or inaccurate reporting on what the agency did could influence a doctor's medical decisions, putting patients at risk."

One important development was adding a prominent boxed warning that babies born to mothers on opioids may experience opioid dependency and exhibit withdrawal symptoms.

The FDA further announced new requirements for holders of ER/LA applications to conduct long-term studies to assess risks of misuse, abuse, hyperalgesia (increased pain sensitivity), addiction, and overdo
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SOURCE American Academy of Pain Medicine
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