MILWAUKEE — The U.S. Food and Drug Administration this week will consider a request from federal law enforcement officials to tighten restrictions on Vicodin and similar narcotic painkillers.
For years, the FDA has balked at stricter controls on the drug hydrocodone, which is used in Vicodin, saying that doing so could limit patients’ access to pain medicine.
But the U.S. Drug Enforcement Administration has again asked the FDA to consider tightening prescribing and other rules on hydrocodone drugs, as addiction and overdose deaths have soared throughout the country.
Beginning Thursday, the FDA will conduct a two-day hearing in Bethesda, Md., on whether hydrocodone products should be more controlled, as are narcotics such as OxyContin and Percocet.
Stricter controls means patients would be allowed fewer prescriptions at one time and pharmacies would have to secure those drugs in locked cabinets or safes.
Previously the FDA has suggested hydrocodone stay classified as a Schedule III drug, stating that it has less potential for abuse than drugs like OxyContin, which are Schedule II drugs.
The FDA’s failure to make this change in the past has frustrated doctors who are trying to reform the widespread use of opioids in American medicine.
Hydrocodone, they say, is addictive, destructive and easy to access.
Annual surveys taken over the last decade show that between 8 percent and 11 percent of high school seniors have used Vicodin illicitly in the previous year, compared with about 5 percent for OxyContin.
In a briefing document filed before this week’s meeting, an analysis by FDA researchers said that while chronic pain patients taking hydrocodone products might develop moderate or low physical dependence, they would not be expected to develop addiction. It said that hydrocodone products have lower potential for abuse than oxycodone, the narcotic using in opioids such as OxyContin and Percocet.
“That’s just not true,” said Jane Ballantyne, a professor of anesthesiology and pain medicine at the University of Washington. “They really don’t have the evidence for that.”
Stricter Schedule II status means that fewer prescriptions can be written at one time. For each visit to the doctor a patient can get up to six months of prescriptions of Schedule III opioids such as Vicodin, compared with up to three months for Schedule II drugs. Schedule II drugs also have stricter handling and storage requirements.
Ballantyne and other doctors say the abuse potential of an opioid is directly related to how quickly it produces a euphoric feeling. Studies show that there is not much difference between hydrocodone and more strictly controlled opioids such as oxycodone.
Douglas Throckmorton, deputy director of the FDA’s Center for Drug Evaluation and Research, said the internal analysis done by FDA scientists does not represent the official stance of the agency.
He said the FDA will not make an official recommendation until after hearing from experts and an advisory panel at the two-day meeting.
“It’s important to give everyone a voice,” Throckmorton said.
At the heart of the controversy is a question that has defied a good answer: Are hydrocodone combination products any less capable of causing addiction and abuse than more strictly controlled opioids such as morphine or oxycodone?
The two-day advisory panel hearing will help determine whether hydrocodone products should become more strictly controlled Schedule II opioids rather than the current Schedule III.
Wilson Compton, a physician and division director at the National Institute on Drug Abuse, said there is not good data showing that hydrocodone products are less addictive than oxycodone products.
Compton said the institute has not taken a stance on whether stricter controls should be put on hydrocodone products. He said it is not a simple decision and the FDA must weigh the abuse potential of the drug against the inconvenience and expense of that will result if it is changed to a Schedule II.
Research done on drug users shows there is relatively little difference in how quickly they experience those positive feelings when given hydrocodone, oxycodone and another opioid, hydromorphone.
“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.”