FDA Requires Much Stronger Warning Signs on Widely Spread Painkillers

The U.S. Food and Drug Administration gave an annoucement that it will now require immediate-release opioid painkillers such as OxyContin and Vicodin to display enhanced warnings about addiction, overdose and death as a result of misuse of the drugs.

This enforcement came once again in a week due to increasing abuse and misuse of the drugs.

Now oxycodone and fentanyl will now have to have a "black box" warning regarding the risk of abuse, addiction, overdose and death.

"Opioid addiction and overdose have reached epidemic levels over the past decade, and the FDA remains steadfast in our commitment to do our part to help reverse the devastating impact of the misuse and abuse of prescription opioids," Dr. Robert Califf, FDA commissioner, said in a press release. "Today's actions are one of the largest undertakings for informing prescribers of risks across opioid products, and one of many steps the FDA intends to take this year as part of our comprehensive action plan to reverse this epidemic."

The "black box" warnings are the FDA's most powerful, and they're meant to teach doctors as they're prescribing medications to patients.

On top of the boxed warning, the FDA said it will add new information about the danger of opioid use for pregnant women and newborn babies as well as how drug affects the usage of antidepressants and other medications.

In Feburary, President Barack Obama suggested an additional $1.1 billion dollars to broaden treatment for prescription drug and heroin abuse. Obama will be attending the National Prescription Drug Abuse & Heroin Summit next week in Atlanta, NDCP Director Michael Botticelli announced.

FDA is planning to review label requirements as new research is presented on interactions with other drugs, including benzodiazepines.

"The FDA has taken an important step here," Dr. Bruce Psaty, a drug safety researcher at the University of Washington, told the New York Times. "This should help improve prescribing practices in the near term."

The FDA has been criticized for pushing hard enough to stem the opioid addiction crisis, especially by Sen. Edward Markey, D-Mass., who tried to postpone Califf's approval to pressure the FDA to do more to fight addiction.

"Today's announced changes to the labels of opioid products will finally reflect what we have known about these drugs for decades - they are dangerous and addictive and can lead to dependency, overdose and death," Markey said in a statement. "It has taken FDA far too long to address the grave risks of these drugs that have claimed the lives of thousands this year alone."

Markey said the FDA has to take action to protect patients. All new opioids should be checked by an advisory committee of apart from experts, for example. Doctors also needs to be educated about how to prescribe pain relief safely, he said.