The FDA Just Slapped The Strongest Warning Label on Pain Pills

March 24th, 2016 | By Brittany Meadows | Posted in Blog

In its latest efforts to address America’s growing problem with prescription drugs – specifically opiates, the Food and Drug Administration (FDA) announced this week that it will now require its “black box” warning label on all immediate-release opioid prescription painkillers – including Percocet and Vicodin, and more than 220 branded and generic drugs. The boxed warning is the strongest and most serious type of warning.

Immediate-release opioid painkillers are among the most commonly prescribed and used in the United States. They account for 90 percent of all prescribed opioid painkillers.

This change comes nearly three years after the FDA approved similar warning to time-released opioid painkillers, such as OxyContin. Now, both immediate and long-acting formulations will have labels highlighting the risks of abuse, addiction, overdose and even death. The new FDA label specifications also spell out instructions to doctors on how to administer the drugs to patients.

The new label, however, does not include a maximum dose level – or recommend lower daily doses of opioids.

The Fastest Growing Addiction in America.

Prescription pill addiction is the fastest growing addiction in the United States. Families across the country are experiencing heartbreak and tragedy resulting from addiction: Damaged relationships, financial ruin, health emergencies, job loss, failed marriages, overdose and death. Addiction and overdose from opiates – specifically prescription painkillers – has become one of the most devastating public health crises facing our nation.

Roughly 48 million Americans – or 1 in 5 – report that they have abused a prescription drug at least once in their life. According to the Center for Disease Control, someone dies from a prescription drug overdose every 19 minutes.

Since 1999, the number of people complaining of pain has remained consistent across the U.S. – however, the sales of prescription opioid pain pills has quadrupled. Even worse? So has the number of deaths caused by opioid overdoses.

Overdose deaths are now the leading cause of death from injuries in the United States.

People who become addicted to prescription pain pills are roughly 40 times more likely to use heroin – as nearly 4 out of every 5 people addicted to heroin started with prescription painkillers.

Will Label Really Make a Difference?

We commend federal health regulators in their efforts to fight an epidemic of abuse and overdose death tied to prescription painkillers. However, it draws the question: Will it really make a difference?

The large uptick in the number of people prescribed and using immediate-release opioid prescription pills happened within the past 15 years. In 2012, the United Nations’ World Drug Report detailed the non-medical use of prescription painkillers “extremely problematic.” So why has it taken so long for these labels?

Not all prescription pill users are getting high on painkillers. In fact, there are many people using prescription medications to combat chronic pain. For those in chronic pain, the warning labels may come as a reminder as to the dangers of the drugs. However, for those using opioid painkillers to get high, it’s not likely the the warning labels will even be read – let alone effective. Most people in active addiction looking to avoid painful withdrawal isn’t likely to sit down and look over an insert that came with the pill bottle – They’re just going take the pill.

The new warning labels are not perfect, however, they are a start and an attempt to make a difference – even if that difference is very small. These labels won’t solve our drug overdose crisis or opioid addiction, but they’re a step in the right direction on a long road ahead.

Check out some of the other regulations, suggestions and funding federal officials have put into place in order to combat prescription drug addiction:

CDC Crackdown on Prescription Painkillers

President Obama Proposes $1.1B in New Funding to Address Prescription Opioid Epidemic

New Measures to Fight Nation’s Deadly Overdose Epidemic

Obama Administration to Seek $500M to Increase Access to Mental Health