10 Jul The Battle Over Zohydro
Some are scratching their heads over the recent FDA approval of a powerful opioid medication called Zohydro ER. Zohydro is pure hydrocodone; the ER stands for extended release. The new drug will provide longer-lasting pain relief compared with others brands of hydrocodone, and some think this will render the new drug more addictive. Detractors of the FDA ruling include the agency’s own advisory panel.
As reported in a New York Times blog by Roni Caryn Rabin, the stakes are high. In 2010, there were 38,329 deaths due to drug overdose and almost 50 percent of them involved prescription opioids – the drugs most often prescribed to manage pain. The nation’s Centers for Disease Control and Prevention reports that opioids today are responsible for more American deaths annually than cocaine and heroin together, along with at least 420,000 trips to the emergency room every year.
Opioid drugs are most often prescribed in one of two forms: hydrocodone or oxycodone. Oxycodone is most recognized under the brand names OxyContin or Percocet. Hydrocodone is most often sold as Lortab or Vicodin. Both drugs are a mix of opioid plus acetaminophen, the active ingredient in the well-known over-the-counter pain reliever Tylenol.
Opposition to Zohydro
Many state officials are also unhappy with the FDA ruling. Massachusetts Governor Deval Patrick attempted to ban the drug in his state. Almost immediately Zohydro’s maker Zogenix challenged the ban in court. The federal judge in the case nullified the Massachusetts-declared ban.
Fellow New Englanders are also worried about the potential risk of Zohydro and are looking for legal means to limit the drug’s availability in their states. In addition, more than two dozen state-level attorneys general have formally requested that the FDA rethink its decision.
Makers of Zohydro say it is a needed alternative for chronic pain sufferers who currently must take shorter-acting forms of hydrocodone every few hours. Zohydro offers longer lasting pain relief with fewer pills. In addition, unlike shorter-acting brands such as Lortab and Vicodin, Zohydro contains no acetaminophen, which has been linked to liver damage.
New Dosage and Formulation Risky
Objectors to Zohydro point out that the drug trials required for FDA approval did not show the new drug to be much improved over current forms of hydrocodone. Further, Zohydro will be sold in 50 milligram doses – a dosage five times greater than even the largest available in faster-acting forms of hydrocodone. Compounding the problem, say critics, is the fact that the more potent pill is not crush-resistant, so abusers can easily pulverize the tablet for snorting or injecting.
FDA Defends Its Decision
In response to criticism the FDA says it must take into consideration the needs of chronic pain sufferers. The government agency says it has put protective measures in place designed to limit access to all opioid drugs and recently approved wider access to an overdose-reversing medication that could save lives imperiled by opioid abuse.
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