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Proposed FDA regs may hurt (literally!) myeloma patients

Home/News, Side effects, Supplements/Drugs/Proposed FDA regs may hurt (literally!) myeloma patients

Proposed FDA regs may hurt (literally!) myeloma patients

Most of you understand how important pain management options are for myeloma patients.  I know dozens of survivors (including me!) living with chronic and sometimes severe pain caused by lesion ravaged bones.  Broken legs, shattered ribs, collapsing vertebrae are all common.  So I’m always concerned when proposals are made to limit access to pain medication.

vicodin 2This week an advisory committee to the FDA recommended sweeping changes that would make Vicodin much more difficult to prescribe and use.

One of our regular “watch dog” readers, Steve, alerted me to this a few days back.  I did a little research and found an excellent article on about it.  Here is an excerpt.  I have highlighted arguments for the side of pain sufferers (US!) in BOLD:

To Fight Addiction, FDA Advisers Endorse Limits On Vicodin

By Robb Stein -January 25, 2013

A key federal panel Friday recommended placing new restrictions on Vicodin and similar prescription painkillers.

At the conclusion of an emotional two-day hearing, the Food and Drug Administration advisory committee voted 19-10 to recommend the agency change how drugs that contain the opioid hydrocodone are classified as controlled substances.

If the agency goes along with the panel’s recommendation, which is typical but not required, the drugs would be more stringently regulated, moving to so-called Schedule II from Schedule III.

The change would impose a variety of new restrictions on the drugs. For example, doctors could only write prescriptions for 30-day supplies and could no longer call in new prescriptions without patients coming back to the office. In addition, nurse practitioners and physician assistants would no longer be able to prescribe them.

The vote was praised by those seeking new restrictions. “I believe that this change will mark a turning point in the epidemic,” said Dr. Andrew Kolodny of the Maimonides Medical Center in Brooklyn, N.Y. “It will lead to less people becoming addicted, which is the most important thing that needs to happen to bring this crisis under control.”

But pain specialists expressed concern about the effect of new restrictions on patients struggling with debilitating pain. “If the FDA agrees with the advisory committee, the decision will have far-reaching impact on access and cost to pain care,” said Dr. Lynn Webster, president-elect of the American Academy of Pain Medicine. “I hope people in pain won’t suffer as a result.”

Top officials at the FDA will now consider the vote in making a recommendation to the Department of Health and Human Services, and the agency isn’t saying when that might happen. In 2008, the FDA rejected a similar request.

“We will pay close attention to everything we’ve heard as we proceed,” the FDA’s Douglas Throckmorton told the panel at the conclusion of the hearing.

Drugs containing hydrocodone are at the center of an emotional debate that pits the needs of pain patients against efforts to fight widespread abuse of these and other opioid painkillers.

More than 136 million prescriptions for these products are dispensed every year, making them the most widely used prescription drugs. Vicodin is probably the best-known hydrocodone medicine, but there are many others, sold under brand names such as Lortab and Norco.

The request for the change came from the Drug Enforcement Agency, which, along with others, argues these drugs are just as addicting and abused as frequently as other powerful opioids such as Oxycontin and Percocet, which are Schedule II drugs.

While powerful painkillers, opioids are highly addictive and are abused by millions. The number of Americans overdosing from these drugs has been increasing rapidly in recent years, and more than 15,000 now die every year, according to the Centers for Disease Control and Prevention.

But about 100 million Americans suffer from chronic pain, and many of them and their doctors fear the change would make it difficult, if not impossible, for these patients to get drugs they need.

The concern is that many people, such as the elderly and those living in rural areas, won’t be able to make the extra trips to the doctor to get new prescriptions, or afford additional visits. Doctors worried about getting into trouble with the DEA may also stop prescribing the drugs, and insurance companies may stop paying for them…

In addition to testimony from DEA and FDA officials and from pain and addiction specialists, the committee heard from several parents whose children died from overdoses after becoming addicted to hydrocodone products. Many of them broke down in tears or expressed anger at the widespread availability of the drugs…

Here’s the link if you would like to read more:

Vidodin 1I understand both sides of the argument.  And there is absolutely no question all types of powerful pain meds are over prescribed.  It’s too bad those of us that need these medications start to feel like criminals for using them.

More tomorrow.  Feel good and keep smiling!  Pat