Is the New Opioid Approved by the FDA Dangerous?

The U.S. Food and Drug Administration approved Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets), an extended-release/long-acting (ER/LA) opioid analgesic to treat severe daily pain that is long-term and for which alternative treatment options are inadequate. Targiniq ER contains Naloxone that blocks the euphoric effects of oxycodone, making it less likely abused than oxycodone alone.

Sharon Hertz, M.D., deputy director of the Division of Anesthesia, Analgesia and Addiction Products in the FDA’s Center for Drug Evaluation and Research said,

“Encouraging the development of opioids with abuse-deterrent properties is just one component of a broader approach to reducing abuse and misuse, and will better enable the FDA to balance addressing this problem with meeting the needs of the millions of people in this country suffering from pain.”

Targiniq ER is a strong opioid pain medicine that can put patients at risk for addiction, overdose and misuse that can lead to death, even the medication is taken as prescribed. It should never be prescribed for occasional pain and definitely not shared with someone else seeking temporary pain relief. Children and teens should not use the drug and it should be properly stored to prevent experimentation and accidental poisoning or death.

The FDA is requiring post-marketing studies of Targiniq ER in order to assess the serious risks of misuse, abuse, addiction, overdose, and death associated with long-term use beyond 12 weeks. Further assessment of the effects of the abuse-deterrent features is also ongoing. It is disappointing that a drug with known abuse potential is being offered to the public for post-marketing study. A longer pre-market trial period for such a strong and dangerous drug is warranted.

Development of opioids that are harder to abuse is important and needed in order to help address the public health crisis of prescription drug abuse and addiction. Holistic treatments are gaining in popularity with evidence of success in pain management, and should be considered when attempting to decrease dependency on medications. Patients need to understand the dangers of prescription painkillers before beginning use, including available alternative treatment options. Discuss any concerns with a health care professional.