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FDA Demands Warning Labels on Opiate Pain Relievers

medicine 2520463 640

medicine 2520463 640

Recent studies show that Americans face more difficulties and adverse scenarios from prescription drugs than they do from illegal street drugs. Studies show that substance abuse is a rapidly growing crisis for a lot of people, and studies even go another step to showcase that rampant death from opioid pharmaceuticals now exceeds all other drug deaths combined. In the last fifteen years, Americans’ addiction to these substances increased dramatically, causing massive difficulty and crisis for millions of Americans.

Recently, the Food and Drug Administration released instructions to pharmaceutical companies to write warning labels on all of their opioid prescription pain reliever products. This order came on the coattails of 2016’s report of highest-ever deaths from opioid prescription pain reliever drugs. In 2016, more than thirty-thousand people died because of opioid pain reliever pills, more than half of the total number of deaths from drugs.

Drug companies now have to write warnings on their pill bottles to inform patients of drug abuse risk. Drug companies also must write warnings on such bottles to caution pregnant women consuming such drugs that such consumption may lead to withdrawal in babies that could be fatal.

After years of turning a relative “blind eye” to the opioid epidemic, the death toll from 2016 was finally the “last straw” for the FDA. This step towards making warning labels on pill bottles was only the first of many steps the organization planned to make, with many other steps on the docket for later down the road.

A “Black Box” Warning

The warnings insisted upon by the FDA in 2016 are called “Black Box” warnings, meaning that the warnings are the most serious possible for prescription drugs. As prescription opioid drugs come in two different classes, extended release and immediate release, it is important for consumers to know exactly what they are getting and what risks they are taking by consuming such pills.

The “Black Box” warning is the strongest warning the FDA can give. It is meant to educate consumers about the pills they are getting, whether they are immediate release or extended release, the relative risk of abuse, how much to take, how much is too much, etc. A black box warning is also meant to educate doctors on the risks of prescribing these drugs to their patients, an education that has been severely lacking recently.

Too Little, Too Late

One senator, Ed Markey of Massachusetts, spoke out about the FDA’s ruling and said it was, “Too little, too late.” He insisted that the FDA should have acted on the opioid addiction epidemic far sooner.

While President Obama was still in office, he made moves in the direction of funding more treatment centers for opioid dependence, and he had some limited success in doing so. Again, however, hundreds of thousands of lives have already been lost and it will take a considerable amount of time and energy to fully remove this problem from existence.

A Problem Turned Epidemic

By the end of 2016, opioid pain drugs hit the top of the chart for causes of accidental and preventable death. More than sixty percent of all drug deaths in the U.S. was because of prescription opioids, a death toll that claimed more than thirty-thousand lives in that year alone.

Opioids now kill more Americans than breast cancer does, with provisional charts for 2017 showing just under seventy-thousand people dying from opioids by August of 2017. When the rest of the numbers are tabulated as to the total death count for 2017, it is likely that the count will be more than seventy-thousand. That’s another highest-ever.

The problem that we face with opioid addiction is not one that will be solved by simply putting black box labels on pill bottles. We need to completely restructure and re-educate the American populace, doctors and patients alike, on how we address pain. As long as pharmaceutical giants are making money off of pain drug-addicted patients, it is unlikely that we will ever fully break free from the pain-drug epidemic that we now face. We need to reform how we as a nation confront and treat pain to make addictive pain drugs a thing of the past.

There was a time when heroin and cocaine were once legal and encouraged in the United States until we all realized how dangerous these supposed “miracle cures” were. Shortly after that, they were outlawed and now heroin and cocaine are completely taboo in our society. We need to take the same approach with opioid pharmaceuticals. We need to branch out and break free from our own self-made shackles of pharmaceuticals and innovate different and healthier ways of treating pain. There is a way out of the trap that is opiates. We just have to make the commitment to finding it and to start on it.

Sources:

https://www.usnews.com/news/articles/2016-03-22/fda-to-require-warning-label-of-abuse-or-death-on-prescription-painkillers

https://www.cnn.com/2016/03/22/health/fda-opioid-black-box-warning/index.html

https://www.markey.senate.gov/news/press-releases/markey-to-fda_warnings-on-prescription-opioids-too-little-too-late

https://www.cdc.gov/nchs/data/health_policy/monthly-drug-overdose-death-estimates.pdf

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