FDA Requests Label Changes To Boost Opioid Safety

Posted on September 11, 2013

In order for a patient to safely take a medication, he or she must be properly informed as to what the medication does and what risks are inherently involved in the intake of a drug.  That’s why labels are so important.  They inform patients of the proper dosage instructions and illustrate the potential side effects to watch out for that should send an individual right back to the doctor.

To boost safety even further, the Food and Drug Administration is altering the requirements of the labels for opioid pain relievers that offer extended release or long acting therapy.  They explain the necessity for such a move and what the next steps are going to be in a new report.

The FDA is concerned about opioids in particular because they actually alter the brain so that pain isn’t perceived in such a way as to cause us, well, pain.  The agency worries that the extended relief forms of such medications might expose patients to stronger forms of the active ingredients and that the effects of the drugs would last longer than a short-form medication’s effects.

The organization hopes to change the labels on these products to reflect the need to look into the viability of less addictive treatments prior to relying on a long-lasting opioid.  To that end, the current label relating how patients who experience moderate or severe pain requiring 24 hour treatment for an extended period of time will be altered to emphasize the severity of the pain necessitated for such a drug and the fact that other treatments failed to do the job, leaving opioids as the only remaining choice.

That’s not all that the new labels will seek to inform consumers of.  The language will reflect the inadvisability of using an opioid to treat pain as it pops up.  Labeling will also explain the possibility of addiction associated with the drugs, yet another reason why alternatives to extended release opioids need to be sought prior to investing in such a drug.

The move is intended to help doctors make a more informed decision when prescribing these types of drugs.  For instance, healthcare professionals should conduct a more thorough evaluation of a patient’s susceptibility to around-the-clock pain rather than just ask the person how much they hurt at a given moment.

The final labeling alteration being made by the FDA will see the directive to pregnant and nursing women and their children to use caution extended to a boxed warning, thus putting that label in a place of prominence.  Companies are now being tasked by the FDA with conducting studies into the longterm ramifications of opioid use so that there will be a greater understanding of risks associated with the drugs.

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