The FDA is expected to tighten restrictions on painkillers containing hydrocodone, like Vicodin, following Friday’s vote by an advisory panel. Under these controls, only written (not faxed or called in) prescriptions from a doctor would be filled, no refills would be allowed, and nurse practitioners and physician assistants could not prescribe the drugs*. These same restrictions already apply to drugs containing oxycodone (including Oxycontin and Percocet). Reducing addiction to prescription painkillers is the goal of the recommendation, though experts debate whether this is an effective approach. Patient advocates argue such constraints will be an enormous burden to those who rely on these drugs for chronic pain.
Prescription drug addiction is not a trivial problem. One hundred people die every day in the US from a drug overdose and the CDC attributes most of those deaths to prescription painkillers. In 2010, about 12 million Americans reported using prescription painkillers recreationally in the previous year.
No one should have to live with the unrelenting misery of chronic pain. Because opioids can make the brain more sensitive to pain and make migraine more difficult to treat, I no longer advocate broadly for the use of opioids for headache or migraine management. In fact, the long-term efficacy and potential harmful effects of opioid use for any type of chronic pain are in question. If opioids aren’t the answer, then patients must have access to other effective therapies, drug or otherwise. Unfortunately, alternative solutions aren’t always available. Pain patients may have to pay the cost — financial as well as physical — of dragging themselves to the doctor each month for medication to manage their pain.
Is there a way to prevent drug abuse without increasing the suffering of people who live with horrible pain?
*States differ on how they implement these restrictions. Some allow doctors to write prescriptions to be filled at a future date. Some allow physician assistants and nurse practitioners to write prescriptions with the approval of a licensed physician.
Have you told the FDA how important it is to include migraine in their new program? Tomorrow’s the final day to do so. Your participation is so crucial that I’ll beg you with lots of exclamation points and all caps: PLEASE, PLEASE SUBMIT YOUR COMMENT TODAY!!!
How? Just go to the FDA’s Prescription Drug User Fee Act Patient-Focused Drug Development Public Meeting and Request for Comments page and click the blue button that says “comment now.”
Add punch to your comment with these statistics and facts that Teri Robert compiled. In her in-person comment at an FDA meeting, she also included this startling information:
- According to a World Health Organization analysis, migraine is responsible for more lost years of healthy life in the U.S. annually than epilepsy, multiple sclerosis, ovarian cancer, and tuberculosis combined.
- Also according to that analysis, severe, continuous migraine is as debilitating as quadriplegia.
Migraine is unlikely to kill those of us who have it, but it sometimes feels like death would be a better alternative. Whether chronic or episodic, migraine wreaks havoc on our lives and our families. It deserves to be recognized and studied with the same resources as any other life-changing illness.
Please, please, please help get migraine included in the FDA’s exciting new patient-focused program by telling them how desperately migraine needs their attention. Inclusion would mean way more time and money spent on — and research and drug development for — this life-altering illness that is typically dismissed as “just a headache.” The deadline is next week, so don’t delay.
In this new program, the FDA will choose 20 illnesses and host a meeting on each illness for patients, caregivers, physicians and other interested parties to cover an “in-depth review of the needs related to treatment, the current state of treatments, disease burden, the human side of living with the disease, and other issues of possible relevance to reviewing treatments that may come before the FDA for review,” according to patient advocate Teri Robert.
What You Can Do
The FDA is currently accepting public comments to help decide which illnesses should be included in the 20. This is where you come in — I beg you to submit a comment highlighting the importance of studying migraine. For most impact, it should be concise, focused and not overly emotional. Comments are due by next Thursday, November 1, so please don’t wait.
Topics to Address in Your Comment
The FDA is specifically looking for the following criteria when deciding the diseases to include in the program. Please address as many as are relevant to you in your comment.
- Disease areas that are chronic, symptomatic, or affect functioning and activities of daily living
- Disease areas that reflect a range of severity
- Disease areas for which aspects of the disease are not formally captured in clinical trials
- Disease areas that have a severe impact on identifiable subpopulations (such as children or the elderly)
- Disease areas that represent a broad range in terms of size of the affected population
- Disease areas for which there are currently no therapies or very few therapies, or the available therapies do not directly affect how a patient feels, functions, or survives.
Facts and statistics you may want to include in your comment, which Teri Robert put together.
Where to Submit Your Comment
Submit your comment at FDA’s Prescription Drug User Fee Act Patient-Focused Drug Development Public Meeting and Request for Comments page and click the blue button that says “comment now.”
A Final Plea
Putting together your comment may take a little time, but it might make the difference in getting migraine recognized as a real and debilitating illness. This will lead to more funding for research into treatments and causes of migraine. Such discoveries could benefit you in the future and will certainly help your children or other young loved ones who have migraine.
Midrin (and all other Midrin-like drugs, including Epidrin) have really, truly been discontinued. I’ve tried to hide from the truth, but can no longer deny that the ONE medication that allows me some semblance of a life has been discontinued for bureaucratic reasons. While there are no similar medications on the market to replace Midrin, having a pharmacist compound the medication is an option.
What are compounded medications? Quite simply, they are medications that pharmacists mix up from their component materials. You can locate a compounding pharmacy in most US states. All you need is a prescription from your doctor. Insurance companies generally pay for compounded prescriptions, though there may be additional costs that you pay for up front, then contact your insurance company for reimbursement. (I found this answer online and have no first-hand experience. If you know more, please leave a comment.)
But there’s a catch… the individual ingredients may be difficult to obtain. Midrin is composed of isometheptene mucate, dichloralphenazine, and acetaminophen. One pharmacist reported that she is unable to obtain dichloralphenazine and my headache specialist said that isometheptene mucate is backordered many places. However, these are only a few reports. It’s up to you to share what you learn!
If you’re a Midrin devotee, keep calling pharmacies — some still have a stash. I found mine at an independent pharmacy. Have your doctor call in a prescription for as many as possible. Insurance will probably only cover one month; if you pay cash, you can probably get a three-month supply. They cost about $1 per pill. Also try your mail-order pharmacy for a three-month supply that insurance should cover. (FYI, Costco and BioScrip are out.)
Read Teri Robert’s post for the politics of Midrin’s discontinuation. She has also found that Prodrin is available, though it doesn’t contain dichloralphenazine.
UPDATE: The Midrin equivalent is being manufactured again! Contact your local pharmacy for availability and pricing. Near me, it’s available at CVS, Walgreens, Walmart and a local independent pharmacy. My insurance covers it with a generic copay.
When I tried to fill my Midrin prescription today, the pharmacist told me that all formulations of the drug have been discontinued. Migraineurs throughout the US have heard the same news over the last three years, though the trouble has become more acute in recent months. Migraine advocate Teri Robert researched the issue and confirms the reports. Midrin, Amidrine, Duradrin, Epidrin, Isocom, Migquin, Migrapap, Migratine, Migrazone (all brand names of meds with the same ingredients as Midrin) and the generic isometheptene mucate/ dichloralphenazone/ acetaminophen have been discontinued.
Midrin appears to be a casualty in FDA’s attempt to subject all medications to current approval requirements. Teri explains,
“Midrin was first made and marketed before the current FDA drug approval process was in place. It was never reviewed by the FDA for efficacy and safety. Nor were any of the other similar products. And that’s where the problem lies.” …
“The loss of Midrin as a treatment option isn’t good news for us. The likelihood of any company investing the time and research dollars necessary to apply to the FDA for a drug equivalent to Midrin is slim. Yes, many people are still using it, but far fewer than before the triptans were developed, and triptan usages is up. The cost of triptans is down since two of them are now available as generics.”
Read all of Teri’s article, including her correspondence with an FDA official, on Help for Headaches & Migraine. Many thanks to Teri for her excellent sleuthing and dedication to helping migraineurs.
I’m crushed to learn that one of the few drugs to provide me with any relief is no longer available.
Update: The Midrin equivalent is once again available as of late 2011. Not all doctors and pharmacists are aware of this. If you are told Midrin isn’t available, tell them that Macoven Pharmaceuticals makes a generic equivalent and ask them to look into it.