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Experts Address Recent Opioid Changes by the FDA

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Kayla Rouser4 years ago

Due to recent troubling concerns of opioid abuse, overdose and death, experts in the field of pain treatment and medicaiton have taken it upon themselves to address the issue.

FDA Actions Send Mixed Message over Opioid Regulation

In September of 2013, the agency announced plans to tighten safety label restrictions on extended release/long acting (ER/LA) opioids.

They also announced plans to change the scheduling for hydrocodone combination medications like as Vicodin (AbbieVie) from Schedule III to Schedule II, increasing the security measures to prevent misuses.

In October of 2013 just one month later, the FDA approved a single entity ER hydrocodone product called Zohydro ER.

Produced by Zogenix Inc, it is a product that does not contain abuse-deterrent technology. The decision to release this product went against the FDA’s Anesthetic and Analgesic Drug Advisory Committee’s recommendation mainly due to concerns about its potential risk for misuse.

Since then, the decision has generated numerous letters and calls to the FDA calling for the reversal of the approval from 29 state attorney generals, and multiple group coalitions.

Zogenix has since released a statement that it has entered into an agreement with Altus Formation Inc., in Montreal, Quebec, Canada to develop an abuse deterrent formulation of Zohydro ER. The effect that these actions will have on the national issue of opioid addiction and overdose remains to be seen.  

Experts Address Opioid Regulation

According to many experts, addressing opioid abuse, overdose, and deaths must go beyond regulation and labeling change to also include educational steps.

In fact, Dr. Stuart Gitlow, president of the American Society of Addiction Medicine (ASAM) and executive director of the Annenberg Physician Training Program in Addictive Disease believes labeling changes will likely go unnoticed by many prescribers and the resulting decline in the numbers of prescriptions written will be slow.

Dr. Gilow claims that education led by medical societies and other organizations will also be necessary to be sure painkiller prescription issues are handled in a manner that is effective and efficient.

Dr. Mark Wallace, director-at-large of the American Pain Society also believes educational programs would greatly benefit current attempts to better regulate opioid prescriptions, but also states that restrictions on chronic opioid therapy for noncancer pain is also necessary.

Dr. Wallace acknowledges that a small group of patients do benefit from long-term opioid use; however, he states that such patients are the exception rather than the rule.


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