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FDA Proposing Tighter Restrictions on Hydrocodone Products — Physician’s First Watch

Medical News |
October 28, 2013

FDA Proposing Tighter Restrictions on Hydrocodone Products

By Kristin J. Kelley

The FDA is recommending that hydrocodone combination products (e.g., hydrocodone plus aspirin or acetaminophen) be reclassified from Schedule III to Schedule II to address concerns over "epidemic proportions" of misuse.

The regulations would increase controls on drugs like Vicodin and Lortab by reducing the number of refills patients can get and preventing doctors from calling in prescriptions over the phone. In an interview with the New York Times, the director of the FDA's Center for Drug Evaluation and Research said the changes could take effect as early as next year. According to the Times' report, the number of deaths from narcotic painkillers has quadrupled since 1999.

The FDA also approved a new hydrocodone product (hydrocodone bitartrate extended-release capsules, marketed as Zohydro ER) for long-term treatment of severe pain. The drug, the first single-entity (i.e., not combined with an analgesic), extended-release hydrocodone product, is a Schedule II substance.

Reader Comments (8)

Daniel Plaisted, Pharm. D. Other Healthcare Professional, Pharmacology/Pharmacy

It is interesting to me to read the comments and see how worried people are about the masses being without pain meds. Maybe it would interested you to know that the U.S. (4.6% of the worlds population) consumes 80+% of the worlds narcotic pain meds. How are other countries able to treat diseases without the use of narcotics, but the U.S. can't? Seems like a great idea to restrict all these medications as much as possible.

ROXANN SANGIACOMO Physician, Psychiatry

Guess this should help drive up ER and URGENT CARE visits on nights, weekends and holidays for folks who need a little pain help...recent post ops puking on their Percocet, dental pts, slip n sprain weekend warriors, unless we just say screw our personal lives and drop everything to meet them in the office in said nights, weekends n holidays...oh yeah, then they'll have an office visit charge.

These government employees at the FDA are just so enamored with how brilliant they are. But I think they are alone in their opinions. These so called physicians are government workers, that's right, 8am to 4 pm M-F, no nights, no call, no 60 hour weeks, no malpractice. If you can't make it in academia, can't take it in private practice, work for the government.

I'm still ticked off about Darvocet. I'll bet that started the run on Vicodin. I personally swapped a handful of pts off Darvocet to Vicodin when they pulled that off the market.

The squeeze for middle ground and doing the right thing gets tighter. Pts have a RIGHT to have their pain managed. We get gigged for doing just that. Ok so somebody figure it out n let me know when they do.

By the way...is all the commotion over RX'd Vicodin or scammed, stolen or otherwise illegally or fraudulently obtained?

Roger Felix, MD Physician, Family Medicine/General Practice

Upgrade of hydrocodone to DEA schedule 2 is long overdue. Don't know if it will help much, but it should be done. I can't understand why oxycodone would be schedule 2 but hydrocodone would remain schedule 3. While we're at it, why isn't carisoprodol scheduled AT ALL? Our New Mexico state board of pharmacy is careful to include carisoprodol in its monitoring program, but this highly addicting more-or-less-barbiturate with a known withdrawal syndrome flows in sedating waves across our state without being listed as a controlled substance. I'm not sure how these categories are determined, but it makes me skeptical about the whole process.

Bruce Alan J.D. Other, Health Law/Ethics/Public Policy

If it is hydrocodone deaths which the FDA seeks to lower, it could start by requiring manufacturers to make a freestanding version without Tylenol or an NSAID. As it stands today, given that the FDA bases its estimates of overdose deaths upon death certificate statements (not autopsy findings), it is literally impossible to tease out deaths caused by hydrocodone from deaths caused by the toxic effects of the acetaminophen that inevitably accompanies it.
A typical Rx of 40 mg of hydrocodone includes the outermost allegedly safe dose of acetaminophen - 4 grams total. There is a very narrow line between an acceptable dose of acetominophen and a toxic dose.
But setting that aside, the obvious intent of further "Scedulizing" hydrocodone is to force more people to turn to OTC medications. In so doing, the number of people who will develop ulcers and cardiomyopathies from NSAIDs will skyrocket as will the death rate, which today is vastly underreported because physicians typically have NO idea how much OTC medication a patient was taking when he/she died.
The other alternative brings us back to Tylenol and the intrinsic and toxic risks to the liver already mentioned.
It's the FDA which is moving its lips but it is the DEA which is actually doing the talking here, and the fact that the FDA has permitted itself to become a drug enforcement mouthpiece instead of a protector of the best interests of patients - ALL patients - is detestable in the extreme.

ANNE AVRAM Other, retierd

I THINK IT IS A GOOD IDEA TO RESTRICT HIDRO AND OTHER LIKE IT ,SURE NOT IN CASES WHERE THE PAIN IS MORE DAMAGING THEN MEDS .

STEPHEN DENNIS Physician, Emergency Medicine

This is like saying, because 4% of the population speed when driving, we are going to put a governor on all cars so no one can go over 35 MPH. Let's punish the many because of the few!

Barry Smith, Ph.D Other, Neurology, Univ. of Maryland

Restrictions on narcotics are certainly needed. However, many patients have chronic pain syndromes (e.g., in cancer) and cannot use NSAIDS due to bleeding. In addition, acetaminophen is the primary cause of liver failure in the U.S. Hence, both physicians and patients need ready access to pain control alternatives, most of which are narcotics. We need to be careful to allow and even encourage physicians to prescribe narcotics when there are no good alternatives, and rules like those proposed by the FDA will leave many patients in pain, once their refills run out. What can we do for those patients? This issue needs to be more fully addressed than it has been so far in order to ensure that patients are not in pain that could be controlled by appropriate narcotic drugs. Note the evidence that addiction is unlikely as long as the patient is in pain.

To clarify, my work is in neurophysiological research.

VIRGINIA CAMPBELL Physician, Emergency Medicine, Emergency Department in rural Alabama

This proposal might sound reasonable at first glance, but I think it will be less effective than hoped and it will lead to unintended consequences for patients that are using hydrocodone properly, especially for those with chronic pain.

Can you imagine having to go to get a written prescription for your anti-hypertensive medicine every month?

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