Legislation aims to revoke FDA’s approval of new opioid Zohydro

fda logo Legislation aims to revoke FDAs approval of new opioid ZohydroA group of lawmakers concerned about health risks and a growing epidemic of prescription drug abuse has introduced legislation to revoke the Food and Drug Administration’s approval of the new, highly potent opioid painkiller Zohydro ER.

“I have tried reasoning with the FDA, and I’ve repeatedly requested the agency change its course on this dangerous drug. Their refusal to budge forces me to introduce legislation,” Sen. Joe Manchin, D-W.Va., said in a statement. He teamed up with Rep. Stephen Lynch D-Mass, and Rep. Hal Rogers, R-Ky., on the bill.

Zohydro ER is the first pure hydrocodone drug to be approved for sale in the United States. Other drugs such as Vicodin and Lortab contain hydrocodone but in combination with other less potent painkillers, such as acetaminophen.

Acetaminophen, the same medication as the over-the-counter Tylenol, has been linked to liver damage when administered in high doses. The FDA says it approved Zohydro because there was a need for the painkiller as a single ingredient medication without other ingredients that may be intolerable to some patients.

Opioids, which include codeine, morphine, fentanyl and oxycodone, deliver a feeling of euphoria that make it a choice recreational drug, thus they are easily abused and misused. Zohydro contains between five and 10 times more hydrocodone than most other opioids. It also lacks abuse deterrents that have been incorporated into similar drugs in its class such as OxyContin. Such abuse deterrents are designed to help prevent the drug from being crushed, where it can then be injected or snorted for an even greater high.

Zogenix, the maker of Zohydro, says it has an abuse-resistant version of the drug in the works but it is still years from reaching the market.

The legislation follows protests from citizen groups, drug addiction groups, and several attorneys general, as well as a Congressional call for an investigation into potential “pay-to-play” claims in which drug companies allegedly paid high sums to participate in private meetings between the FDA and medical professionals in order to influence the approval of Zohydro.

Source: Law360