New FDA Painkiller Labeling Rules Seen as Good PR but Bad Medicine

Friday, September 13, 2013

In an attempt to slow down the growing problem of prescription drug abuse and overdoses, the Food and Drug Administration (FDA) has developed new rules targeting powerful painkillers like oxycodone and others that experts say are too frequently being given to patients.


But critics of the plan say the changes fall far short of what needs to be done to effectively curb the epidemic of painkiller-related overdoses in the United States.


The changes were prompted by the significant rise in prescription drug overdoses, which have been a leading cause of preventable deaths in the U.S. for the past four years. These types of fatalities, in fact, have surpassed those caused by auto accidents.


It is estimated that more than 12 million people abuse opioids each day.


In 2010 alone, 16,651 overdose deaths were attributed to overuse of these painkillers, according to a report this year from the Centers for Disease Control and Prevention. That number—a 300% increase from about a decade earlier—amounted to enough opioid painkillers to medicate every American every four hours for a month, claimed the Center.


The new FDA guidelines will advise doctors to be more cautious in prescribing certain opioids, which many people take in the form of OxyContin, Opana and other brand named drugs.


But such drugs account for less than 10% of all opioid prescriptions written in the U.S.


Another group of opioids, including hydrocodone, were not included in the new guidelines. Hydrocodone, along with oxycodone, was among the most frequently cited drugs involved in the nearly 4,000 prescription drug deaths that occurred over a six-year period in Southern California, which were studied in a recent Los Angeles Times analysis.


The rules will also require pharmaceutical manufacturers who make opioids to conduct new research to determine what doses and forms of these drugs are most likely to create problems for patients.


But, again, the FDA didn’t go far enough, critics said, because the guidelines don’t address the marketing of opioids by drug companies.


“This is just more hot air,” Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing, told The L.A. Times. “This makes it look like they are doing something. But they are continuing to allow opioid manufacturers to promote their products for conditions where the risks are likely to outweigh the benefits.”


Kolodny said his organization was considering suing the FDA to force it to impose tougher prescribing limits.


The drug industry’s marketing campaigns have intensified over the years, resulting in a quadrupling of opioid sales during the past decade. During that same period, the number of painkiller-related overdose deaths has skyrocketed.


“To reduce the harm from opioids is going to take a lot more than a label change,” Lynn Webster, president of the American Academy of Pain Medicine, told the Times. “People who are in severe pain often take more than is prescribed to them, so limiting the label indication is not going to prevent that from happening.”


Under current law, labels on long-acting and extended-release opioid narcotics indicate the medicine can be prescribed for “moderate-to-severe” pain. The new rules will remove “moderate pain” from the FDA’s list of approved uses for the drugs, replacing it with “pain severe enough to require daily, around-the-clock, long-term opioid treatment” for which alternative treatments have failed, according to the Times.


Additionally, the new FDA rules will not affect the labeling of fast-acting opioids, which are usually prescribed by doctors to address pain following dental work, surgery or injuries.


Vicodin was the most prescribed painkiller in the U.S. last year, dispensed by pharmacies more than 135 million times. It will not be affected by the FDA’s new rules.

-Noel Brinkerhoff, Danny Biederman


To Learn More:

FDA Orders More Stringent Labeling for Opioid Drugs (by Lisa Girion and Melissa Healy, Los Angeles Times)

FDA Announces New Labeling Rules for Opioid Painkillers, Including Oxycodone (by Brady Dennis, Washington Post)

FDA Orders Starker Warnings on Some Painkillers (by Matthew Perrone, Associated Press)

Goal of Label Changes: Better Prescribing, Safer Use of Opioids (U.S. Food and Drug Administration)

FDA Panel Advises Limiting Prescription Refills for Addictive Painkillers (by Matt Bewig, AllGov)

Florida: More Deaths from Oxycodone than Cocaine (by Noel Brinkerhoff, AllGov)


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