• Categories
  • Archives

FDA Pushes Back Against Opioid Epidemic

Opioid

[DIGEST: CNN 1, 2, Philly, NBC, FDA, Opana]

For the first time, the Food and Drug Administration (FDA) is seeking to ban a previously approved opioid due to its addictive qualities. In this decision, the FDA specifically recognized the public health risk of the opioid epidemic and committed to making other similar evaluations with other drugs.

FDA Aims to Ban Opana ER

On June 8, 2017, in an unprecedented move, the FDA requested Endo Pharmaceuticals take one of their opioid pain medications—reformulated Opana ER (oxymorphone hydrochloride)—off the market because of its extreme abuse risk. The FDA rendered this decision, following its advisory panel vote in March of 18-8, based on an updated risk-benefit analysis of the drug.

Opioid
Credit: Source.

The FDA explained in a statement: “After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks. This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse.”

“My comment is ‘wow,'” according to Dr. Andrew Kolodny, co-director of opioid policy research at the Heller School for Social Policy and Management at Brandeis University. “This is pretty exciting. This is big news.”

Opana ER was originally approved in 2006 to manage long-term, round-the-clock, moderate to severe pain. Unfortunately, many people began to abuse the drug—achieving a quick, intense high by crushing, then snorting or injecting it. In fact, the drug is approximately two times more potent than OxyContin, which is also frequently abused.

In response to the abuse, Endo replaced the formula for Opana ER in 2012, seeking a label that described “abuse deterrent properties” from the FDA. The FDA approved the new version of the drug, but denied the new labeling because there was insufficient evidence to

To read more, please continue to page 2.

Pages: «   1   2   3   ...     »   View All

Tags:

  • Amy McElroy is a contributing editor and writer for Rewire Me. She has written for print, radio, and online publications such as The Bold Italic, The Billfold, Noodle, Cosmopolitan, BlogHer, and others. Her website, amyjmcelroy.net, lists her editorial services. She’s on twitter at @amyjmcelroy. Amy balances her work at the computer by teaching yoga and fitness.

  • Show Comments

You May Also Like

Add Scents to Your Messages with an Aromatic App

Proud of that beef bourguignon you're slaving over? Snap a pic, tag it with ...

Technologies That Could Enslave Humanity

While humans continue to mold and shape technology, it's just a matter of time ...