Pharmaceutical

FDA chief defends agency’s decision to approve controversial painkiller Zohydro

fda logo FDA chief defends agencys decision to approve controversial painkiller ZohydroPeople in pain need more treatment options, Food and Drug Administration (FDA) Commissioner Dr. Margaret Hamburg said last week at a hearing of the Senate’s Health, Education, Labor and Pensions Committee, defending the agency’s decision to approve the controversial new painkiller Zohydro. Several activists groups, attorneys general and lawmakers have questioned the FDA’s approval for the opioid painkiller, saying the country doesn’t need another highly addictive and easily abused medication on the market.

Zohydro is the first pure hydrocodone drug to be approved for sale in the United States. Other hydrocodone drugs, such as Vicodin and Lortab, contain hydrocodone in combination with a less potent painkiller such as acetaminophen. The FDA has previously warned that acetaminophen in high doses can cause liver damage. Because it is an ingredient in both prescription drugs and over-the-counter medicines, many people inadvertently take higher than recommended doses of acetaminophen.

Zohydro is in a class of medications known as opioids, which also includes codeine, morphine, fentanyl and oxycodone (OxyContin). They deliver a euphoric high that makes them an ideal recreational drug. Zohydro, however, is between five and 10 times more potent than other hydrocodone drugs. It also was not formulated with any abuse deterrents, as some of the newer opioids have been. Thus, Zohydro can easily be crushed and snorted or injected for an even greater high.

Some critics argue that the FDA should have waited for a pure hydrocodone formulated with abuse deterrents rather than approving Zohydro. But Hamburg countered that claim. “I would love if we had abuse-deterrent formulation regulations that were actually effective,” she told the committee. “It does not do any good to label something as abuse deterrent if it is not actually abuse-deterrent.”

Hamburg said that the FDA and other experts need to work together to come up with better abuse deterrents that actually work. Until then, the millions of Americans who suffer from chronic pain deserve more options.

Zohydro was approved by the FDA last October despite a recommendation from its advisory panel not to approve the drug. The new opioid entered the market this month.

Source: NBC News