Wednesday, December 29, 2010 Migraines for 38 years asks

Q: Is it legal to prescribe a medication with a black box warning to NOT use the medication for headaches or migraines?

Specifically, I am asking about Actiq (Fentanyl lozenges).

I have used Actiq for a couple of years to relieve the pain of extreme migraines, so that I would be able to do things, such as open Christmas presents, spend time with my family, eat Christmas dinner. I have missed so many special occasions because of migraine and tried so many treatments, to no avail. Occasional use of Actiq allowed me to spend more time with my family. Early this year, my physician said that he could no longer prescribe Actiq because of this black box warning. I have a 14 year old daughter who believes that I am totally undependable because of the many activities that I've had to cancel due to severe migraine.

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Answers (2)

Teri Robert, Health Guide

12/30/10 1:24pm

Migraines for 38 years,

-:¦:-•:*'""*:•.-:¦:-•*Welcome to MyMigraineConnection!*•-:¦:-•:*'""*:•.-:¦:-

Once a medication is approved for human use, it's legal for doctors to prescribe it for any condition they feel appropriate, despite black box warnings. So, the answer to your question is, "Yes."

That said, there are very good reasons for the black box warning, and there are good reasons why most doctors will not prescribe medications like Actiq for Migraines and headaches. These medications are intended for use for breakthough pain by people who are already taking opioids 24/7. They are not intended for "as needed" use or for acute use.

Opioids, including Actiq, can actually make Migraines worse. There are multiple reasons why they're not recommended for Migraine. You can read about this in Opioids for Migraines - Why Not?.

PLEASE know that I understand your situation, having been there myself, and I'm not being at all critical of you. I really want you to feel better and be able to have a good quality of life.

The best suggestion I can give you is to find a real Migraine specialist. That was the first step back to a real life for me when I was in bed all day five or six days a week with Migraines. It's important to note that neurologists aren't necessarily Migraine and headache specialists. Take a look at the article Migraine and Headache Specialists - What's So Special? If you need help finding a Migraine specialist, check our listing of Patient Recommended Migraine and Headache Specialists.

I'd love to help you if I can. Please let me know if I can do anything for you?

Welcome again,

Teri

PMer

12/30/10 8:15am

There is no "black box" warning on Actiq. Many insurance carriers won't cover it because it is approved for cancer patients only and is very expensive. My insurance covered it just fine until the price got really high, then they pulled out the "cancer only" excuse, when it was really a cost issue.

However, Drs can prescribe any Drug for any reason....Legally. I take Actiq for migraines and have done so for over 10 years. I am lucky in that I have a compassionate, understanding Doc. I can definitely relate to everything you wrote. I would suggest you either push back with your Doc, or find a new one. Is this Doc a PM Doc? What med did he replace the Actiq with? I hope he didn't put you into horrible WDs.

Moderator's Note: Please see Teri Robert's reply to this answer. Parts of it are incorrect.

Teri Robert, Health Guide

12/30/10 1:33pm

PMer,

-:¦:-•:*'""*:•.-:¦:-•*Welcome to MyMigraineConnection!*•-:¦:-•:*'""*:•.-:¦:-

Yes, there is a black box warning on Actiq. It was added in 2009. Here's a copy of it:

WARNING: IMPORTANCE OF PROPER PATIENT SELECTION, DOSING, and POTENTIAL FOR ABUSE See full prescribing information for complete boxed warning.

Must not be used in opioid non-tolerant patients. (1)
Life-threatening respiratory depression could occur at any dose in patients not taking chronic opiates. (5.2)
Contraindicated in management of acute or postoperative pain including headache/migraines. (4)
Contains fentanyl, a Schedule II controlled substance with abuse liability similar to other opioid analgesics. (9.1)
Contains medicine in an amount that can be fatal to a child. Keep out of reach of children and discard opened units properly. (5.3)
Use with strong and moderate CYP450 3A4 inhibitors may result in potentially fatal respiratory depression. (7)

It's also important to read this section of the prescribing information:

----------------INDICATIONS AND USAGE---------------

ACTIQ is an opioid analgesic indicated only for the management of breakthrough cancer pain in patients 16 and older with malignancies who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients must remain on around-theclock opioids when taking ACTIQ. (1)

I hope you'll read my reply to Migraines for 38 years. Migraine treatment has advanced a great deal in recent years, and there are more ways than ever to manage the disease.

Welcome again,

Teri

Q: Is it legal to prescribe a medication with a black box warning to NOT use the medication for headaches or migraines?

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