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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

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 highly 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.”

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.

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.

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.

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