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New FDA Opioid Pain Killer Label Change Category: Pain Management by - October 19, 2013 | Views: 29408 | Likes: 4 | Comment: 4  

FDA Opioid label changes

Opioid abuse, misuse, addiction, overdose and death is a crisis. According to the Centers for Disease Control (CDC) about 3 of 4 prescription overdose deaths are caused by prescription pain killers. In 2008 14,800 deaths resulted from opioid overdose, higher than the number of deaths from cocaine and heroin abuse. 

The Food and Drug Administration (FDA) recently introduced changes to the risk evaluation and mitigation strategy (REMS) program for extended-release (ER) and long-acting (LA) opioid medications such as Oxycontin (oxycodone). This program was originally introduced by the FDA in 2011 and approved on July 9, 2012.

Adam M. Kaye, Pharm.D., FASCP, FCPhA, a Clinical Professor of Pharmacy shares his views about the new FDA guidelines for use of long-acting and extended-release opioids. 

The FDA unveiled new opioid guidelines on Tuesday, September 10, 2013. What is the new guidance for prescribers? 

The indication for long-acting and extended-release opioids was modified from “for moderate-to-severe pain” to a confusing new indication that states “to be used for pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatments have failed.” 

The FDA did not add any restrictions preventing “off-label prescribing.”

Do you think these labeling changes will do much to prevent the million of people who abuse these opioids and the thousands of overdose deaths as estimated by the CDC?

The program is more of a compromise than any kind of policy that has any teeth. Leaders of the FDA hope that new drug labeling guidelines will prompt physicians to prescribe our most powerful opioid painkillers in a more responsible fashion. 

  • How can these label changes help reduce opioid abuse? 
  • Most patients have already tried an alternative treatment such as NSAID or hydrocodone product. 
  • Many prescribers are not familiar with opioid warnings, side effects and drug interactions. 
  • Prescribers may not even notice the new labeling changes in a crowded package insert? 
  • Insurers do not have a way of restricting the use of these agents after only one or two short courses of short-acting opioids?  
  • Prescribers are looking for sustained pain relief for their patients that often have only subjective complaints or chronic injuries that surgery is not expected to relieve. 

What prompted these new opioid guidelines?

I believe that pressure from the media and organizations including Physicians for Responsible Opioid Prescribing have continued to push for stronger warnings and limitations on these powerful and often misused pain treatments.      

What is a possible solution for treating patients with intractable pain without increasing the already skyrocketing level of narcotic overdose deaths?

A warning label hidden inside a package insert is not going to reduce this epidemic of drug addiction and senseless deaths. Around-the-clock pain treatment is very difficult to manage. Pain management with narcotics should probably require consultation of an interventional pain physician. Opioid-induced endocrinopathy is still a relatively new idea. Consider that insomnia, mood, stress-response, libido, and even thyroid function are affected by long-acting opioids. Opioids and all the other adjunct therapy need to be used cautiously in chronic pain patients. 

Which medications interact with opioids and contribute to opioid misadventures?

Patients treated for pain often receive benzodiazepines (hypnotics), muscle relaxants,   and a few short acting pain killers in addition to  one or two long-acting opioid tablets or long-acting topical patch. All these drugs can cause can compromise breathing and increase sedation. Diphenhydramine (Benadryl) and promethazine with codeine also interact with opioid pain management therapy. Promethazine with codeine is often abused and seldom necessary in patients already taking medications like hydrocodone or oxycodone. Use of an additional opioid increases the risk of potential serious additive respiratory depression. 

When will drug manufactures complete revising their labeling?

The FDA expects manufacturers to complete revising their labels by December 2013. 

What are some additional measures for the FDA to consider that will help curb opioid abuse? 

According to Lynn Webster, president of the American Academy of Pain Medicine, “to reduce harm from opioids is going to take a lot more than a label change.”

The FDA should consider tougher prescribing procedures. For example, prescribers and patients should document that they know the “risks and benefits” of use and abuse of these powerful agents.  

Computer based risk management programs similar to iPLEDGE may help limit the distribution of all opioids. This may seem extreme but it may help with documentation of education about benefits and risks of opioid use and may provide additional clarity to patients that these medicines are powerful and should not be abused. 

Better partnerships between physicians and pharmacists will help. Physicians and pharmacists can sign a simple pain contract or agreements that the patient will see only one doctor for their pain management and long-acting C-II medications. These pain contracts or agreements should be transmitted by fax or with the hard copy prescription to the dispensing pharmacy to create a partnership between patient, prescriber, and pharmacist in the patients pain management.


FDA announces the elements of a risk evaluation and mitigation Strategy (REMS) for extended-release and long-acting

FDA risk evaluation and mitigation strategy (REMS) for extended-release (ER) and long-acting (LA) opioid.

Policy Impact: Prescription Painkiller Overdoses


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