Tougher Painkiller Limits Needed by FDA?

Tougher Painkiller Limits Needed by FDA?

January 28th, 2013 // 7:13 pm @


After a widely anticipated two-day hearing late last week, an FDA advisory panel voted 19-to-10 to place Vicodin and other prescription painkillers that contain hydrocodone under greater restrictions. The agency is likely to follow the recommendation, but the debate over such a move is unlikely to have ended.

At issue is an increasing effort to find a midpoint that balances patient needs for pain relief with ongoing concerns over abuse and addiction associated with these medications. The meeting was held at the request of the US Drug Enforcement Agency, which maintains these prescription drugs need to be more tightly controlled.

As we previously reported, a 2010 report from the US Centers for Disease Control and Prevention noted that the rise in overdose deaths in the US paralleled a 300 percent increase since 1999 in the sale of prescription painkillers. The drugs were involved in 14,800 overdose deaths in 2008, more than cocaine and heroin combined.

Meanwhile, misuse and abuse was responsible for more than 475,000 emergency department visits in 2009, which nearly doubled in just five years (read the CDC report here). And emergency department visits related to hydrocodone totaled 115,739 in 2010, more than double 2004 admissions, according to a recent report from the Substance Abuse and Mental Health Services Administration (here is the report).

Such sobering data illustrates why the DEA has pushed to change combination drugs containing hydrocodone to Schedule II status, which is the same restrictive designation for drugs with only hydrocodone. Currently, combination drugs are listed as Schedule III. The FDA previously rejected the change in classification, according to FDA documents filed for the meeting (read here).

Most panelists agreed. “I’m appalled to see that hydrocodone is the most prescribed drug in the US and that has to be something very wrong with our health-care system and society for this to happen,” said Maria Suarez-Almazor, a professor of internal medicine at the University of Texas MD Anderson Cancer Center, who voted for more restrictions, according to Bloomberg News.

At the same time, the meeting also presented an opportunity for patient advocates, industry representatives and pain specialists to argue that restricting access to hydrocodone combination drugs would limit treatment for patients. In recent months, media stories have noted how some patients are finding it increasingly difficult to fill legitimate prescriptions as the DEA cracks down on pharmaceutical distributors and retailers.

“Many of us are concerned that the more stringent controls will eventually lead to different problems, which may be worse,” said John Mendelson, a senior scientist at the Addiction and Pharmacology Research Laboratory at the California Pacific Medical Center Research Institute in San Francisco, according to The New York Times.

Nonetheless, the FDA is likely to adopt the panel recommendation. Although the agency is not legally obligated to do so, FDA officials have been under pressure to address the issue. Earlier this month, the FDA issued a draft guidance that attempts to help drugmakers determine which studies should be conducted to develop medicines to thwart abuse and the labeling claims that the agency may approve (back story).

So what would the restrictions look like? The proposal would drastically alter current practices. Patients would not be able to refill prescriptions without an entirely new prescription for their physician. And faxed prescriptions and those that are called into pharmacies would be forbidden. Meanwhile, distributors would be required to store the drugs in special vaults.

This is clearly going to be a difficult balancing act. On one hand, the numbers show that abuse and addiction are worsening problems and efforts to formulate new types of medications may not mitigate concerns quickly or sufficiently enough. And on the other hand, patients who suffer from pain may, indeed, find it more difficult to fill prescriptions if doctors are dissuaded from prescribing certain drugs and pharmacies become more selective in dispensing. What do you think?

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