Product News and Recalls

Zohydro lawsuits predicted after controversial FDA approval

In October, the FDA approved a new hydrocodone-containing pain medication known as Zohydro Extended Release. This approval has caused some controversy among doctors, pain specialists, and addiction organizations, because, according to CNN, it is five times more powerful than other pain medications. If the predictions that Zohydro will cause injury come to pass, then Zohydro lawsuits are likely in the future.

Doctor Concerns about Zohydro


According to CNN, pain medication abuse is the leading cause of preventable death, responsible for more than 16,000 deaths in 2010.

Over 40 healthcare groups wrote an open letter asking the FDA to reconsider its approval, and predicting Zohydro would cause additional deaths. And 29 states attorney generals have asked the FDA to reconsider its decision.

Meanwhile, one FDA advisory committee voted 11-2 to not approve Zohydro, and the FDA has stated its increasing concern “about the abuse and misuse of opioid products, which have sadly reached epidemic proportions in certain parts of the United States.”

Zohydro lawsuit risk


From a Zohydro lawsuit perspective, the key question is whether the risks and benefits of the drug are adequately described in the label. All drugs require a risk-benefit analysis, but only with full information can doctors and patients make an informed decision about whether the benefits outweigh the risks.

According to the open letter, two Zohydro pills could cause a fatal overdose, while just one pill could kill a child. Indeed, prescribing information states on page 5 that: “Accidental consumption of even one dose of Zohydro ER, especially by children, can result in respiratory depression and death due to an overdose of hydrocodone.” There are other warnings concerning the potential for overdose and abuse, but we do not know whether San Diego-based Zogenix provided all of the information that it has, and whether it conducted appropriate studies before marketing the drug.

It remains to be seen whether Zogenix properly described all of the risks associated with Zohydro. If people are injured because the benefits were overstated or the risks were understated, then a Zohydro lawsuit might be a good way to ensure proper warnings.