Johnson and Johnson Under Scrutiny by DHH for Nucynta
According to the Wall Street Journal, Johnson and Johnson has received a subpoena from the Department of Health and Human Services (HHS) requesting documents and information concerning their opioid painkiller, Nucynta.
The subpoena comes after increased reports of painkiller abuse and overdose.
Johnson & Johnson and Nucynta Subpoena
- Nucynta comes in two forms: an immediate release tablet and an extended release tablet.
- The immediate release form of Nucynta was approved by the FDA in 2008. The extended release version was approved in 2011.
- The subpoena is seeking any studies, reports and complaints regarding the study of the tablets on the subject of actual or potential side effects.
- This includes company documents and information on promotional practices, marketing and sales of both forms of Nucynta.
- The subpoena came from the HHS Office of Inspector General – a department that normally focuses on allegations of fraud and abuse in federal health programs.
Side Effects and Adverse Events Related to Nucynta
For complete list, click here.
- Weak Pulse
- Weak Breathing
- Slow Heartbeat
- Respiratory Depression
Of 1,156 adverse events reported through the FDA, 67 (5.8%) resulted in death. Reports of deaths peaked in late 2011 after the launch of Nucynta’s extended release tablet.
Current Precautions Taken with Nucynta
Currently, extended release Nucynta carries a prescribing label that warns about respiratory depression and a potential for abuse.
Doctors must undergo training on how to prescribe the correct amount of extended release Nucynta to avoid over-prescription of the drug.
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