The FDA’s approval of the hydrocodone drug Zohydro ER has been met with criticism from health care professionals and lawmakers alike, and members of Congress, including Rosa DeLauro (D-CT), Harold Rogers (R-KY) and Stephen Lynch (D-MA), have requested an investigation into the matter from the Office of the Inspector General.
Explore This IssueACEP Now: Vol 33 – No 06 – June 2014
Zohydro ER, approved in October 2013, contains five to 10 times more hydrocodone than any other drug on the market and lacks safeguards to prevent immediate release through the snorting or injecting of the drug’s easy-to-crush form. The FDA’s Anesthetic and Analgesic Drug Products Advisor Committee displayed overwhelming opposition to Zohydro ER, with an 11-2 vote against its approval. This recommendation, combined with efforts to reclassify hydrocodone from a Schedule III drug to a Schedule II drug, has led many members of Congress to question why Zohydro ER was approved at all.
Media sources, including Milwaukee’s Journal Sentinel and The Washington Post, claim that pharmaceutical companies influenced FDA officials during their participation in pay-to-play initiatives set up by professors at the University of Rochester and the University of Washington. Opioid misuse is becoming more frequent across the United States, with opioid overdoses accounting for an average of 15,000 deaths per year. In an effort to reduce opioid misuse, Massachusetts attempted to ban the sale of Zohydro ER, although a federal judge denied the request.
Congressional leaders are not the only ones taking notice of Zohydro ER’s controversial approval; many emergency physicians are aware of the questions surrounding the new prescription painkiller. While the investigation into Zohydro ER’s approval continues, it is up to individual emergency physicians to choose whether they prescribe the controversial drug or not.
Jessica Kinsella is a writer based in Hoboken, New Jersey.