FDA Acknowledges America’s Drug Epidemic, Requests Stricter Warnings on Opioid Painkillers

by Sokolove Law

WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) announced plans earlier today (Tuesday, March 22nd, 2016) to change some prescription opioid painkiller labels to include their toughest possible warning. Federal regulators have made today’s announcement in direct response to America’s prescription opioid epidemic.

Just how serious is America’s addiction to prescription painkillers? The “opioid epidemic”, as it’s been dubbed, is so severe that it claims the lives of nearly 50 Americans per day.

The agency first signaled that it would be toughening its stance on labeling requirements last month, when Dr. Robert Califf, Commissioner of the FDA, announced a series of measures to be taken in 2016. Certain members of Congress, including Senator Edward Markey (D-MA) have for years now been putting pressure on the FDA’s commissioner for allowing more opioid painkillers into a U.S. drug market already saturated with opioids and rife with evidence of abuse.

What Today’s FDA Mandate Means for the American Public

Opioids are the most widely used prescription painkillers in the U.S., with over 135 million prescriptions filled every year. As such, they also happen to be the most abused. In fact, more U.S. deaths are due to overdoses than car crashes. This latest move by the FDA is part of a multi-pronged governmental effort to stem the abuse and addiction problem of opioid medications such as OxyContin®, Percocet®, and Vicodin®.

The FDA’s new warning will require a boxed label – the toughest-yet label in the U.S. – to be placed on immediate-release opioid painkillers that contain the semi-synthetic compound oxycodone. Today’s announcement comes 3 years after the FDA’s bolder warnings were placed on long-acting opioid drugs, such as the well-known OxyContin®, which, counter to immediate-acting opioid painkillers, releases its dosage steadily over a 12-hour time period.

It also comes one week after the Centers for Disease Control and Prevention (CDC) announced new standards for opioid prescribing.

What today’s label-change requirement means is that a majority of opioid-based drugs will now bear a label that provides information about addiction, abuse, overdose, and death. Opioid drug labels will also include language that warns about the potential risks for a serious central nervous system condition called serotonin syndrome, serious adrenal gland disorders, and decreased sex hormone levels.

One Small Victory in a Giant, Ongoing War against Prescription Drugs

Today marks a minor victory for an embattled American public suffering from an incredibly serious and deadly epidemic – but there is still a long way to go. With some of the largest pharmaceutical and medical device companies lobbying our government’s politicians at the rate of $240 Million a year (in 2015), it has been – for a while – difficult to make any sort of meaningful dent in the war against prescription opioids. And with each passing day, while profits for these companies grow larger and larger due to unscrupulous sales tactics and lack of change in federal regulation, more and more lives are lost to addiction and overdose.

Many criticize the government for being slow to react to the epidemic, but the American public has learned nothing if not that changes at the federal level come at a snail’s pace.

When it comes to prescription opioids, some critics of the FDA remain unimpressed with measures taken by the CDC and the FDA, claiming that none of it goes far enough. Senator Markey wrote in an email statement to the New York Times that, “[the changes] will reflect what we have known about these drugs for decades – they are dangerous and addictive and can lead to dependency.”

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