Discover your next big idea for life sciences at PACK EXPO Las Vegas
Experience a breakthrough in life sciences packaging—explore solutions from 2,300 suppliers spanning all industries, all in one place this September

FDA Tells Endo to Pull Opioid Opana ER From Market

The FDA says the benefits of Opana Pharmaceuticals’ extended-release painkiller no longer outweigh the risk of abuse.

Opana ER / Image: Rich Pedroncelli
Opana ER / Image: Rich Pedroncelli

A recent Philly.com article provided an update on a topic we touched on earlier this year regarding the safety of Endo’s Opana ER. Back in March, an FDA advisory panel voted 18-8 that the drug was more often used for harm than good. Injection abuse of the drug has been linked to outbreaks of both HIV and hepatitis C, and a severe blood disorder called thrombotic microangiopathy.

A statement from the FDA declared, “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.” According to The Centers for Disease Control and Prevention, opioid overdoses have hit record highs, killing more than 40,000 people in 2015.

Break out of the ordinary: see what’s new in life sciences packaging
<strong>At PACK EXPO Las Vegas, you’ll see machinery in action and new tech from 2,300 suppliers, collaborate with experts and explore transformative solutions. Join us in September to experience a breakthrough for life sciences products.</strong>
REGISTER NOW & SAVE!
Break out of the ordinary: see what’s new in life sciences packaging
FDA warning letters surge - is your team prepared?
New guide reveals expert strategies to prevent regulatory issues and respond effectively to FDA enforcement actions in pharmaceutical and medical device manufacturing.
Read More
FDA warning letters surge - is your team prepared?