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FDA to weigh tighter rules on Vicodin

Published on NewsOK Modified: January 23, 2013 at 11:39 am •  Published: January 23, 2013

“The data suggest that the relative potency of these three commonly abused opioids do not differ greatly from one another … ,” University of Kentucky researchers wrote in a 2008 paper in the journal Drug and Alcohol Dependence.

A similar finding was made in a 2009 paper in the same journal in which an oxycodone/acetaminophen product and a hydrocodone/acetaminophen product were tested on volunteers who had a history of drug use.

Most opioids are about the same in their ability to cause abuse, said James Zacny, a researcher at the University of Chicago and lead author of the 2009 paper.

“From a pharmacology standpoint, I don’t think there is a lot of logic to say one is different than the other,” he said in an interview.

Lynn Webster, president-elect of the American Academy of Pain Medicine, said the issue is complicated, and his organization will not be taking an official stand on whether to put stricter controls on hydrocodone.

Webster, a Salt Lake City pain specialist who will speak at the FDA hearing, says his personal experience with opioid abusers suggests they prefer Schedule II oxycodone drugs over Schedule III hydrocodone drugs, but he acknowledged there is not much good data supporting that belief.

In reality, there probably isn’t a great deal of difference between the drugs, he said.


He said his organization will not oppose stricter controls on hydrocodone but that may cause problems in delivery and access to care.

For example, if hydrocodone drugs are reclassified, more anti-inflammatory drugs, like ibuprofen and Celebrex, may be used, which could lead to greater risk of cardiovascular problems.

Some doctors may decide to prescribe more methadone, another opioid painkiller, but because many doctors are not well-trained in using that drug, there could be more methadone overdoses, he said.

Another possibility, he said, “Docs may choose not to prescribe at all.”

That could slow a trend that has been building for years.

As opioid use grew through the 2000s, so did U.S. overdose deaths, reaching 14,800 in 2008, the most recent year that death data was available.

Americans consumed 99 percent of the 39 tons of hydrocodone used in the world in 2009, as well as 81 percent of the 77 tons of oxycodone.

FDA researchers concluded that one of the reasons hydrocodone products were less likely to be abused than drugs such as oxycodone was because all hydrocodone products are combined with over-the-counter pain relievers. Adding non narcotic ingredients such acetaminophen lowers the abuse potential because it reduces the amount of hydrocodone needed, they said.

However, others have looked at FDA’s data and concluded there is no proof that hydrocodone is significantly less abused.

“It is a threat to the public health,” said Robert DuPont, president of the Institute for Behavior and Health, a nonprofit group working to reduce illegal drug use.

DuPont, a former director of the National Institute on Drug Abuse, co-authored a Jan. 16 letter to the FDA, showing that as sales and use of hydrocodone and other opioids have increased over the years, so too have unintentional overdose deaths and hospital admissions for opioid emergencies.

In his letter to the FDA, DuPont said a lot has been learned about the potency and abuse potential of hydrocodone since it first was classified as a Schedule III drug 40 years ago.

“Today, we know that this drug is both potent and highly addictive,” he and his co-authors wrote. “Updating the classification of hydrocodone … would be one of the single most important interventions the federal government could implement to bring this raging epidemic under control.”


(This story was reported as a joint project of the Milwaukee Journal Sentinel and MedPage Today. MedPage Today provides a clinical perspective for physicians on breaking medical news at


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