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FDA Extends Warning Requirements for Opioid Painkillers

Jason Reese

Opioids are drugs used to relieve pain by acting on opioid receptors in the central nervous system. The drugs can be natural derivatives of opium, such as morphine, or they can be semi-synthetic or synthetic versions, including hydrocodone, oxycodone, and fentanyl. Opioids are intended for use by individuals who need round-the-clock relief of very severe pain, and they come in primary classes related to the release of medication into the body. There are extended release and immediate-release opioids, with immediate-release drugs carrying less opioids but needing more frequent dosing. Immediate-release painkillers account for ninety percent of human consumption.

In 2013, the FDA believed it was working to combat drug overdoses and addiction by requiring label changes on extended release opioid painkillers. The new labels will state the drugs should be used only when “alternative treatment options are inadequate.” The move was intended to create additional conversation between patients and doctors about how to most safely manage pain in the midst of an ongoing crisis of prescription drug abuse and addiction. The World Health Organization estimated more than 16 million people used opioids in 2012.

Unfortunately, the FDA’s move was largely unsuccessful in its hopes to decrease rates of abuse, so they have now gone one step further in addressing the problem, requiring a “black box” labeling for fast-acting or immediate-release opioids. Black box labels are the most stringent the FDA can require while still allowing the drugs to be available to those who need them. Black-box warnings are intended to clearly highlight a serious negative reaction that could be disabling, life-threatening, or fatal. For doctors and patients both, the warnings serve as notice that appropriate limitations on the use of a drug can prevent or reduce serious adverse reactions and are meant to influence the risk-benefit analysis that doctors undertake when prescribing pain relief medication.

Risks of Opioid Use

Many users of opioids find their body develops tolerance for the drugs over time and therefore, they need more and more of the medication to get the same amount of pain relief. Opioids also create physical dependence, which means your body learns to need the drugs and will go through withdrawal when deprived of them. These factors certainly have an impact on the development of opioid addiction and abuse, a serious problem affecting nearly every community across the United States and the world. There are, however, other very serious potential side effects, including:

  • Overdose or Death—especially since opioids are very dangerous to combine with alcohol and other sedating medications, such as anti-anxiety and seizure medications, muscle relaxers, and sleep aids.
  • Opioid-Induced Hyperalgesia—some patients develop this condition after using opioids for a long period of time. In short, the opioids cease to kill pain and instead cause pain and sensitivity in multiple areas of the body.
  • Lung and Heart Problems—these issues occur in relation to the sedation caused by opioids, which impact the brain’s ability to control breathing and potentially causing damage to the lungs and heart by providing a decreased rate of air and oxygen over time.

Are you or a loved one experiencing negative effects from the use of opioids to manage pain? Do you feel as if your doctor failed to warn you of the significant risks and provide safer alternatives? The defective drug attorneys at Wagner Reese are experienced in medical malpractice, product liability, and wrongful death and can provide you the knowledge you need to pursue a case against those who have wronged you and your family. Call now for a free consultation: (888) 204-8440.


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