Sights set on striking a balance between the benefits and risks

FDA update on labeling rules for long-acting opioid analgesics

In April of this year, The U.S. Food and Drug Administration (FDA) has approved new safety-related changes for the class-wide labeling of extended-release and long-acting (ER/LA) opioid analgesics used for pain treatment.  In the fall of 2013, they also added new post-market study requirements for this class of drugs.

The FDA Commissioner Margaret A. Hamburg, M.D. said, “The FDA is invoking its authority to require safety labeling changes and post-market studies to combat the crisis of misuse, abuse, addiction, overdose, and death from these potent drugs that have harmed too many patients and devastated too many families and communities.”  Hamburg also stressed, “We must also recognize the medical value they have for many patients living with pain.  Therefore, the agency must strike a balance between their benefit in treating patients with pain and the risks associated with misuse, abuse, addiction, overdose, and death.”

The goal is to change the language to assist professionals in the healthcare industry to write prescriptions based on a patient’s own needs.  Previously, the labeling language focused on a patient’s condition or treatment for that condition.  Now, the focus is on the severity of the patient’s pain.

One parameter insists on the patient having moderate to severe pain.  The pain should be severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

There have been thousands of deaths every year due to addiction, abuse, and misuse of these opioids.  The most recent survey (from 2009) shows that around two million people in the U.S. are using pain relieving prescriptions.  This number is significantly higher than heroin or even cocaine.  According to the Center for Disease Control (CDC), more than 16,000 people died from overdosing on opiates in 2010.  Research in the last 10 years indicated a minimum risk for opioids.  Because of this, their use became rampant and available for treatment for much lower pain-related elements.

The most common ER/LA opioid analgesics is OxyContin, which uses oxycodone.  There are several other market and generic brands of these drugs.  “These labeling changes describe more clearly the risks and safety concerns associated with ER/LA opioids and will encourage better, more appropriate, prescribing, monitoring and patient counseling practices involving these drugs,” says the Deputy Director for Regulatory Programs at the Center for Drug of Valuation Research, Douglas Throckmorton, M.D.

Currently, labeling is the most effective way to inform users of these drugs of the risks and dangers.  Along with labeling changes, there will be better use of monitoring, and counseling when prescribing these opioids.  There will also be post-market studies and clinical trials to monitor results, and assess risks of misuse, abuse, hyperalgesia, addiction, overdose, and death.  The new label will include directions for dosage, administration, warnings, drug interactions, and patient counseling.

All containers will also include a boxed warning on ER/LA opioid analgesics warning against neonatal opioid withdrawal syndrome (NOWS).  Newborns can be exposed to the drugs before birth.  Symptoms of NOWS include tremors, rapid breathing, excess crying, and more.  The safety labeling changes have been finalized.

Another way drug companies are combating misuse of opioids is by making the drug more difficult to crush.  The powder turns into a gel and this in turn makes it more difficult to snort or inject.  This is used by the most common opioid, OxyContin.  They are also making it harder to extract or separate from the inactive ingredients.  The opioid Targiniq ER now has an anti-euphoria component to the drug when crushed, which counteracts the “high” experienced by the user.

Dr. Throckmorton stresses that these methods may deter misuse or death, but people can always find ways.  Simply increasing the amount taken is a perfect example of this.  While the measures being taken will likely change and be even further approved, it is a much-needed safety measure.


story by JO LYNN DEAL

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