Testimony Before the FDA’s Drug Safety and Risk Management Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committee Regarding a Hydrocodone-Acetaminophen-Promethazine Combination Product
In testimony before a joint meeting of the Food and Drug Administration’s (FDA’s) Drug Safety and Risk Management Advisory Committee Anesthetic and Analgesic Drug Products Advisory Committee, Public Citizen urged the committee to recommend that the FDA not approve a hydrocodone-acetaminophen-promethazine combination product for the short-term management of acute post-operative pain severe enough to require an opioid analgesic and the prevention of opioid-induced nausea and vomiting in patients who are at risk for or have a history of nausea and vomiting because an unfavorable risk-benefit profile.
See Public Citizen’s other work on opioid drug issues.