Health Advocates Lobbying FDA To Stop Sale Of Painkiller

The FDA has already approved the release of Zogenix manufactured painkiller Zohydro. However, health advocates and doctors have begun a campaign to lobby the FDA to reconsider their course of action. Zohydro is an opioid that is possibly lethal. The drug’s active ingredient can be deadly if consumed by patients who aren’t familiar with painkillers. The drug can also be lethal if ingested by children.

Health advocates believe that the drug simply isn’t safe. In a petition to the FDA, health advocates and industry experts wrote, “Someone unaccustomed to taking opioids could suffer a fatal overdose from just two capsules. A single capsule could be fatal if swallowed by a child.” The letter is currently under review by the FDA, per agency spokeswoman Morgan Liscinsky.

The healthcare community isn’t alone in pushing for the FDA to reconsider. Attorney generals from over half of the states in the country have also asked the FDA to rethink their position on the drug’s release. Zogenix has countered the growing opposition by releasing a statement saying their drug will be “subject to stricter prescribing and dispensing rules.” If there are no changes by the government agency, Zogenix will start selling the painkiller this month.

There has been talk of the FDA making painkillers more difficult to obtain. Many painkillers, such as Zohydro, contain hydrocodone. In October, the FDA voted in favor of rescheduling hydrocodone drug products. A recommendation was sent to the DEA, which this past week has proposed a new rule to officially reclassify hydrocodone drug products.