Product Liability

FDA launches program to help reduce risk of opioid abuse

The Food and Drug Administration (FDA) has launched a new program designed to help cut down on the abuse of long-lasting opioid painkillers, a move that goes against the recommendation of the agency’s advisory panel.

Opioids are potent painkillers used to manage pain, but because they also cause a euphoric sensation, they are easily abused and are often subject to criminal diversion. Long-lasting or extended-release versions of opioids are particularly dangerous when abused.

Over time, individuals have learned effective ways to tamper with these medications by cutting, chewing, breaking or dissolving them, allowing high levels of the active ingredient to be released at once. This can cause overdoses and death. This practice has been performed not only by abusers, but also by healthcare practitioners who administer the drug to patients who are unable to swallow tablets.

The FDA’s new program seeks to educate patients and doctors about how to reduce the risk of these types of abuses.

The FDA is creating a risk evaluation and mitigation strategy, or REMS, for long-lasting opioids that goes beyond the usual package insert. It includes a medication guide and a plan to communicate risk information to both patients and doctors.

While the FDA’s intentions appear noble, the advisory panel voted 24-10 against the plan, recommending instead a stronger plan that would also include shorter-acting opioids. The FDA is not required to follow the advice of its advisory committees, but it usually does.

Drugs covered by the new plan include the following opioids:

• Avinza
• Butrans
• Dolophine
• Duragesic
• Embeda
• Exalgo
• Kadian Capsules
• MS Contin
• Opana ER
• Oramorph
• OxyContin
• Palladone
• Fentanyl extended-release transdermal system
• Methadone
(all versions, as methadone remains in the body for extended periods)
• Morphine extended-release tablets
• Oxycodone extended-release tablets