States Battle with FDA over Powerful New Painkiller

Thursday, May 01, 2014

Political leaders from several states are challenging the federal government’s approval of a powerful new painkiller that critics say could exacerbate the problem of prescription drug abuse.


At issue is the Food and Drug Administration’s (FDA) approval of Zohydro, the first single-ingredient, opioid-based painkiller. Unlike other hydrocodone drugs, such as Percocet and Vicodin, Zohydro does not contain acetaminophen, making it more pure and more powerful.


Public health experts have warned that Zohydro could worsen the nation’s epidemic of overusing prescription drugs unless something is done to limit its availability. That’s why Vermont and Massachusetts are trying to impose restrictions on prescribing the drug in their states.


In the case of Massachusetts, Democratic Governor Deval Patrick attempted to prohibit Zohydro’s sale altogether. But a federal judge threw out the ban, saying federal law (or more specifically the federal authority of the FDA) trumps such state restrictions.


Now, Patrick is trying other ways to limit the drug’s availability through the state Board of Registration in Medicine. That body approved a rule that requires doctors to complete a risk assessment and pain management treatment agreement with patients before prescribing Zohydro. In addition, physicians who want to prescribe Zohydro would have to participate in the Prescription Monitoring Program, which keeps tab of how many times a drug is prescribed.


In Vermont, Democratic Governor Peter Shumlin has taken similar steps by mandating, among other things, that doctors determine whether other drugs can treat a patient’s pain before resorting to Zohydro.


Attempts to ban the drug outright within state boundaries are being made elsewhere, such as Ohio, where lawmakers have introduced legislation on the subject. Members of Congress from Kentucky and West Virginia as well as from Massachusetts have introduced bills to ban Zohydro. In addition, 29 state attorneys general have asked the FDA to reconsider its approval of the drug.


More than 6 million Americans abuse or misuse prescription drugs, according to a report last year by the Trust for America’s Health. Overdose fatalities involving prescription painkillers have quadrupled since 1999, making such deaths greater in number than those caused by heroin and cocaine combined.

-Noel Brinkerhoff


To Learn More:

Fearing Abuse, States Challenge FDA on Painkiller Approval (by Michael Ollove, Stateline)

Zohydro: Why This New Painkiller Could Spark Another Addiction Epidemic (by Loren Grush, Fox News)

Mass. Limits Use of the Potent Painkiller Zohydro (by Milton J. Valencia, Boston Globe)

Alarmed Healthcare Providers Ask FDA to Reverse Approval of Powerful Painkiller (by Noel Brinkerhoff, AllGov)

FDA Overrules Expert Panel to Approve High-Potency Painkiller (by Danny Biederman and Noel Brinkerhoff, AllGov)


autismepi 2 years ago
This is not a simple debate because the list of risks for acetaminophen is long and growing. The most serious concerns are two new studies which show adverse neurodevelopment in children whose mothers used acetaminophen while they were pregnant. The study in 3 year olds (Brandlistuen et al. 2013) found a 70% increased risk of motor and behavioral problems and double the risk of communication problems (autism phenotypes). The study in 7 year olds (Liew et al. 2014) found increased risk of ADHD behaviors and Hyperkinetic Disorders. This is in addition to close to 30 studies finding an association to asthma and allergic disorders, 4 studies finding an association to male congenital malformations (cryptorchidism) and additional studies finding associations to skin disorders and mind numbing (relief of existential dread).
anonamouse 2 years ago
It's ridiculous the lengths this society goes to in order to complicate the lives of the six million Americans cited above who might "abuse" prescription painkillers. Those six million comprise less than 2 percent of the population, yet the other 98 percent must forgo safe and effective pain relief (i.e., morphine), and instead use acetaminophen-laced drugs which pose the risk of serious liver damage or liver failure (it's on the label, folks) when used in dosages necessary to provide "equivalent" pain relief. As usual, lawmakers are gung-ho when it comes to limiting other people's options when they are in pain. (Despite Bill Clinton's bogus claim that "I feel your pain," he couldn't and didn't --- it's a metaphysical absurdity. btw, the article fails to mention the actual number of overdose deaths due to abuse, saying only that they exceed those of heroin and cocaine. How many people are we actually talking about here, and how does that number stack up against the numbers of people who die as a result of using the socially sanctioned drugs tobacco and alcohol?

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