Monday, May 28, 2012

Midrin for Migraine: What's Going On?

By Teri Robert, Health Guide Monday, December 13, 2010
For the latest update on this situation see Migraine Meds Epidrin, Midrin Update 1/28/11. For many Migraineurs, Midrin has been the best medication they've ever found for treating their Migraines. For some with a history of or risk factors for stroke and other cardiovascular issues, it's been the ...
Migraine Update: Harvin's Migraines, Midrin, Holiday Tips, More...
12/13/10 6:43pm

Teri,

 

I'm not in this situation, but I know that Midrin is some people's only option for relief. On those people's behalf, I want to thank you *so* much for investigating this. You continue to amaze me in the extent you go to to fight for us Migraineurs.  It really moves me how driven you are and how much you care. Thank you for pursuing this. You probably don't get told enough how much every single thing you do gets appreciated. Thank you.


With gratitude,

Kelly

12/13/10 7:28pm

When I filled my last prescription for Midrin I asked my pharmacist how their supply was doing and was assured they had their shelves full.  Sure enough six weeks later they are out. She is calling around for me to see if she can find any locally.

 

I had an appt with  my migraine specialist today and fowarded your wonderful article to her.  I echo Kelly's thank you.  I am sure you will let us know if our voices could be heard and where we should direct them.

 

Gratefully,

lisa

12/14/10 7:13am

Thanks so much for looking into this, Teri.  I don't take Midrin, but I wanted to say how much I appreciate all of your hard work and research.  We are so lucky to have you.  Jena x

12/14/10 11:40am

I really really appreciate the information, especially since I use Midrin.   Thank you so much for all you do for us! Smile

12/14/10 1:30pm

Hi Teri,

 

First let me thank you for all you do on behalf of all migraneurs; your devotion to our health and well-being is greatly appreciated!

 

The action of the FDA effectively bans Midrin.  If no one will manufacture it, you might as well call it gone.  This action is unconscionable, as I know from personal experience that it is a marvelous drug for occasional, acute attacks with few side effects.  Once again our "LOCO Parentis" Big Brother has done more harm than good in an FDA ruling, close on the heels of a ridiculous ban on Darvon and Darvocet.

 

In the link that listed...

 

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ucm118712.htm#carbinoxamine

 

...it was apparent that other migraine treatments are also under attack.  All ergotamine products are now being eliminated,  and that would include caffergot, which some people have found to be beneficial for acute episodes.  An anti-nausea suppository is being cancelled (useful for extreme migraine attacks.)  In addition, opiods of all types are under siege at various manufacturers; codeine sulfate, hydrocodone (Vicodin,) morpine sulphate, hydromorphone (Dilaudid,) and oxycodone (Percocet.) 

 

A phsician friend, when discussing pain management, told me this just this week:  "Earlier this year the morphine elixir that is the mainstay of pain control in hospice care was nearly pulled from the market (despite years of safe use) because the FDA stated it had not gone through the proper approval processes in the past.  Fortunately, a massive outcry from the hospice organizations were able to forestall this.  (Of course, no one makes much money on morphine elixir.)

 

The italic emphasis is mine, not his, but you get the idea.  No one makes much money from making time-tested, generic drugs.  The dough comes - for everyone - with the latest and greatest designer creations.  I'm not implying, of course, that there is any collusion between the FDA and the drug industry.  Why, that would be wrong, and illegal.  The thought never crossed my mind...

 

12/14/10 2:41pm

For someone in acute pain I'm starting to think the goverment is trying to thin us out as our pain gets so sever because we will no longer have effective medicines we will all just end our lives. Also as someone on medicare I can tell you the fight I have getting migrain drugs I was on midrin which for me was the best medicine but they would no longer cover it so I changes to fiocet which they will cover sometimes and sometimes will not I'm greatfull it is a low enough price I can afford to pay for it when they won't fill it. I wish all of you out there suffering my greatest hope and as everyone else here thank you Teri for all you do.

12/14/10 10:50pm

I am starting to wondering if there is nor a plot to leave us painers in the cold. So many medications are hard to get if not entirely off drug stores.

I was picking up some meds today and the pharmacist was telling me about the difficulty to get some brands. Some of our pills had to be changed for a comparable  scary

Marie

Anonymous
penina
12/15/10 1:28pm

Hi,

 

I read through the link R3 provided.  It seems that although some of this action is very recent, particularly about the opiates, but some of it is a few years old.  For example, the ergotamine letters date from 2007, yet I use three ergot products, DHE 45 (well the generic version), migrainol and methergine, and although my pharmacy has to order these products when I need them, I've never had any problems getting them.

 

Does anyone have any further information about this?  

 

I think if I couldn't use ergotamine products my treatment would be much less effective, since the best functioning triptans only partially abort migraines for me.

 

And the information about the opiate based pain-killers is ridiculous, what do they expect the ER (hospitals, hospice etc) to give people in extreme pain?  Shots of toradol for everyone?  Or people with severe chronic pain (other than things like migraines which get rebound...)?

 

Teri Robert, Health Guide
12/15/10 2:24pm

Penina,

 

The issue with the ergotamine medications is the same issue that we're not seeing with Midrin.

 

You might want to take a look at the post I wrote when the ergotamines were discontinued, FDA Orders 20 Unapproved Ergotamine Medications Discontinued.

 

Some ergotamine medications have gone through the current FDA approval process. That includes Migranal, D.H.E. 45, and Cafergot. You can find a listing of ergotamine medications that have been approved by the FDA by going to Drugs@FDA and entering ergotamine in the search box.

 

Hope this helps!
Teri

12/15/10 4:30pm

In response to the hydrocodone, Vicodin is FDA approved.  Apparently they are looking at cough suppressants that have added the drug into it that aren't approved.

 

From the FDA site:

"Today's action will have the most impact on consumers who use unapproved cough suppressant products that contain hydrocodone. It appears that the many currently-marketed hydrocodone pain relief products (e.g., Vicodin) that are listed with the agency have FDA-approved applications. Most of the hydrocodone cough suppressants on the market, however, lack FDA approval."

 

I do feel bad for everyone who uses any of these drugs successfully.. it's like a shot in the foot to all the pain sufferers who use these drugs SAFELY and EFFECTIVELY!  The FDA gets to say "we got the bad guys" while the good guys (the patients) have to suffer.. very frustrating.

12/16/10 11:46am

I just have to share my frustration here...

 

Am I the only person who thinks the FDA should spend a little more time on clinical review of new drugs and a little less time pulling drugs that have been safely used for years?  I mean, every year it seems some drug that was plowed through the FDA has to be pulled or black boxed b/c it's killing people, or causing strokes or some other awful side effect.  Uhm, Vioxx anyone?  What about Avandia? 

 

Not to mention these are the same idiots in charge of our food supply.  How many outbreaks of salmonella and e.coli where there last year?  Oh, too many to count.

 

Just saying, FDA's time could be better spent..... Sorry this is kind of a rant, but I'm frustrated and stressed.  I can't use triptans (they make my pain worse and abort nothing), so all I'm left with is DHE, which I've never tried and may or may not work.  After 3 years of chronic migraines, I finally find an abortive that helps, and now I'm back to square one. 

 

Anonymous
Judy J.
1/ 3/11 4:12pm

Never crossed my mind either...  never, ever....

12/16/10 12:54pm

My thanks also to Teri for staying on top of this and

for sharing the FDA letter with us.

 

Some excellent observations and information also

in the responses here:

 

1. "No one makes much money from making time-tested, generic drugs."

    So true.  So many times, it's all about the money. 

    What is sad here is that what does work well for

    some people has to be eliminated. What a definition of

    greed that is.

 

2. On a previous SharePost: "My neurologist told me that it is about

    to be off the market completely.  He said that it is an older drug

    that came around in the early 1960's and since it is older and

    affordable, big drug companies are wanting it off the market. 

    If they take it off the market we will be forced to pay ten times

    the price for something that doesn't work half as good."

 

    Time has proven this statement to be true.

 

3. "the FDA should spend a little more time on clinical review of

    new drugs and a little less time pulling drugs that have been

    safely used for years?"

 

    Amen to this.  Absolutely pure and solid common sense.

 

 

Well, now to add my comment ~

 

1. Please note the sentence in the FDA letter:

 

   "The products you are referring to are not generics,

    but rather other products that contain the same

    ingredients as Midrin."

 

   A very interesting statement, accurate and interesting.

 

2. Remember the compounding pharmacies.

 

   With a script from your doctor, you can go to a

   compounding pharmacy in your area and have

   them make up the prescribed medicine - Midrin.

 

   The downside of this is that they don't accept

   nor process health insurance prescription coverage.

   The cost has to be paid totally out of pocket.

 

   Affluent people use this resource to obtain the

   medicines that they need. 

 

   I have used it for meds for my kittens and luckily,

   so far, the cost has been no more than $30 per

   fill.

 

3. Remember the small town, 'Mom and Pop' pharmacy.

 

   Three years ago, the big pharmacy chains told me

   that Midrin is no longer available.

 

   In a small town nearby, the local pharmacy

   continues to fill my script.  Although, this may end

   soon.

 

 

Hope this helps.  And thanks for all your comments.

 

 

 

 

 

 

 

 

1/24/11 10:22pm

What about Prodrin?  A mom & pop pharmacy suggested this.  It is very pricy though.  I can't find out if it has been discontinued as well.  The pharmasist says he can still get the Prodrin.

Teri Robert, Health Guide
1/24/11 10:38pm

As far as I can tell, it too is discontinued. When current supplies are gone, no more will be available.

 

Teri

12/20/10 12:05pm

I just called four different compounding pharmacies, and no one will make it because it's supposed to be a manufactured drug.  The fact that no one is manufacturing it doesn't seem to make a difference.  I have one last Hail Mary to try, but I've pretty much given up hope.

 

I also tried finding it on online pharmacies, US and Canada, and no such luck.

 

Oh, and I found this on the American Society of Health System Pharmacists website.  It lists all the versions that are discontinued, which I think is all of them. 

 

http://www.ashp.org/Import/PRACTICEANDPOLICY/PracticeResourceCenters/DrugShortages/GettingStarted/CurrentShortages/bulletin.aspx?id=275

 

And now I think I'm going to go send a nasty email to the FDA.  It won't put any Midrin in my medicine cabinet, but I think it will make me feel better to yell at them. 

12/20/10 5:59pm

UPDATE ON COMPOUNDING:

 

If you can't find a pharmacy, keep searching.  I was tipped off to one in TX by a friend that will compound it.  Right now I'm trying a few closer to home first, here in the NYC area.  Don't give up if your neighborhood pharmacy won't do it.  I called 10 in my area, and no dice, but I've got a good feeling about a couple I emailed.

 

So fingers crossed!

 

I'm still sending a nasty email to the FDA tho Wink

 

12/22/10 8:29pm

Hey Kat, sure hope that you can find one that

will do the fill.  We, here in OH, are all rooting

for you. You NYC area'ers can do it!

 

Btw, the fellow on here who originally offered

this 'compounding pharmacy' suggestion, about

2 years ago, was from TX.

 

 

 

1/ 5/11 5:32pm

I just posted this on the forums too but I found a compounding pharmacy who is sending me my midrin prescription as I type this!  Don't give up looking if this is what you need. 

12/28/10 2:47pm

An E-Mail to the FDA is like Sissing into the wind, you may feel good but what did you accomplish?

 

Write to your Congress Person and take about the "Law of Unintended Consequnces".

 

Your republican will want to reign in these unelected tin despots and your democrat needs to hear it.

 

Thanks,

 

Springfield Rifle 

Anonymous
Judy J.
1/ 3/11 4:05pm

Thank you, Teri, for letting the people at the FDA know that there are a whole lot of us out here that depend on Midrin to stop our migraine headaches.  I am hoping they will allow this safe, effective, and inexpensive drug to continue to be marketed.  It really does work!  (P.S. I come from a family of migraine sufferers and family history of stroke so will not touch Triptans with a ten-foot pole). 

1/ 9/11 8:03pm

I just send this email to the FDA's Center for Drug Evaluation and Research, and will be sending something similar to the relevant government officials. It's not much but I hope it will at least present a somewhat compelling argument. Or, at very least, provide an opportunity for me to VENT.

 

~~~~~

 

To Whom it May Concern,

I am writing to express my great concern that Epidrin has been discontinued along with similar medications, indirectly (as I understand it) due to actions of the FDA.

I realize that the FDA has not directly pulled this drug, but to require additional testing of a drug to which no one owns a patent virtually guarantees that it will no longer be available to people who need it. For a drug that has been safely used since the 1960s (and safely used by me personally since 1995), additional testing seems needless, and requiring such testing will ultimately cause patients to switch to other medications (such as Imitrex) that *are* risky, especially for people like me who have a family history of stroke. Our only other alternatives are barbiturates and opioids, neither of which are safer for long term use compared to Epidrin (especially because of their addictive potential), and neither of which many have found to be as effective.

Moreover, many of the alternative medications are far more expensive, as Epidrin was inexpensive enough that even migraine sufferers without insurance could quite easily afford to treat their condition. Many will now not be able to afford relief.

In other words, by putting companies that manufacture Epidrin and drugs like it in this position, you are ultimately depriving people who depend on this medication of something they rely upon as well as making it more likely that they will have to switch to other drugs that are more dangerous, more addictive, more expensive, and potentially less effective. The potential increase in opioid addictions and cardiovascular events that could ultimately result from this discontinuance would be directly on the FDA's hands.

Migraine drugs like Epidrin allow certain people with migraines to lead more normal lives. Some of these people will now end up enduring great pain, and may now find that their migraines interfere with their ability to live and work in a way they did not when Epidrin was accessible. These individuals might find it hard to make a living or even make it through the day without the one drug that provided relief.

Regardless of the FDA's intentions, placing these stipulations upon the makers of a medication this old and this inexpensive, without providing a means of funding the additional research being requested, nearly guarantees that it will become unavailable to the people who need it. Who would conduct this additional research in order to sell a drug this inexpensive?

If the FDA is truly concerned about safety, this organization would not create a situation that drives patients from a drug known to be safe toward drugs that are known to have great risks. I am very upset about this and plan to contact as many organizations about this as I can.

There has been some speculation that the recent enforcement of these FDA requirements might be motivated in part to aid the pharmaceutical industry in marketing newer and more expensive migrine medications to patients who formerly used Epidrin and medications like it. Obviously, this possibility is particularly disturbing.

I would appreciate a response that addresses these issues, and I request that you provide the contact information for any individuals involved with such decisions so that I might contact them to voice my strong disagreement with how this situation has been handled.

Many individuals suffer from migraine and many of them find Epidrin to be their only hope at relief. I have written this message in hopes that their voices may be heard.

Thank you very much for your time. I appreciate your work to protect the safety of Americans, and I thank you for taking the time to consider the enormous problem created by the FDA's recent actions regarding Epidrin and medications like it.

Best Regards,
XXXXX

1/10/11 10:21am

I couldn't said better my self. I'm 100% behind you. I take the Generic for Epidrin(Acetaminophen/dichloralphenazone/isomethepthene) It gives me great relief and I'm very leary and the risk of other pain Med and other Med out there. I'v been on these Med since 2004. It's a Miracle Pain Relief for me. I have a History of Stroke in my family. I want to keep from getting a Stroke because I'm having a pain Med being discontinued by the FDA and switching to something else with risky side effects. I'm upset about the discontinued of Midrin,Epidrin and Generics. It helps my Migraine pain and I can afford it. I'm a shy person. I would get ahold of the news paper or media and voice your opinion about Migraines and what the FDA is doing about the Midrin Family of Relief. I hope this helps. You have my support.

1/10/11 10:46pm

Excellent, well-stated letter.  Thanks for taking the

lead on this.  Please let us know of any response.

 

 

Anonymous
MajorDistances
1/11/11 1:33am
Thanks for the kind and supportive comments, everyone.

I hope people reading this might take the time to write a similar letter. If you google "FDA Center for Drug Evaluation and Research" the first search result contains the email address. It need not be long or fancy...but for every email they recieve, they likely assume that many others are upset, so there is strength in numbers.

Today I recieved a very uninformative letter saying that the FDA could not respond further because it has not taken action on this medication. Then other information was provided similar to the content of the letter posted in the blog. Their assertion that they haven't taken action is arguably false depending on what they mean by "taking action", as I mentioned in my reply (below). However, it did appear that an actual person was responding, which is at least a good sign that these complaints aren't being sent into a total void.

Trying to think of who else to contact about this...



To Whom it May Concern,

It does not appear that anyone actually read this letter. As I stated, I am aware that the FDA has not discontinued the product, but it *has* required additional testing for a product that's been used safely since the sixties. Because drug companies can't make money keeping it around, the FDA's actions ultimately have the effect of depriving patients of a cheap, effective drug and leaving them to use more dangerous drugs in its place. In that sense, the FDA has indeed taken actions that have led to this situation, so your comment that the FDA has not taken action is problematic.

Does those at the FDA care about the patients who will be affected by these actions, who I described in my initial email? Are they taking steps to ensure that a safe, cheap, effective drug will not disappear because it does not make anyone enough money to defend it? Or are they perfectly comfortable letting a medication that people depend upon disappear?

There is no reason that the FDA cannot directly respond to my message.

Thank you again for your response and your service in protecting Americans.

Best,

XXXXXX

Anonymous
L.Colquitt
1/ 9/11 8:12pm

I am a Family Nurse Practitioner/Associate Degree Nursing Professor and work part-time in an after hours clinic; I prescribed Midrin the other day for a patient (I knew it was an old medication, but I checked my quarterly drug reference and it was still listed); I prescribed it for the patient and got a call from the pharmacy that it could not be filled. I do alot of continuing ed on meds and had seen nothing about it; I gave him BuPap instead; it is indicated for tension headache, but I have used it for some really bad headaches (I also have migraines, but don't take any of the triptans due to my blood pressure) and it really helps; you might try it....also another medication that is very similar in ingredients is Dolgic and there is another newer brand name, but it doesn't come to mind right now....startes with an "O".

Might talk to your healthcare provider about it.

1/ 9/11 8:24pm

As I understand it, both of the drugs you've mentioned are barbiturates, which are highly addictive and work quite differently than the ingredients in Midrin. They might an be effective substitute for some, but not for me.

 

My doctor recently prescribed me Fiorinol as an alternative to Midrin. Unfortunately, because of its addictive potential, I'm not supposed to take it more than twice a week, and I can't take very much when I do. Moreover, I have found it to be quite ineffective anyway. Somewhat like taking an Excedrin with a Benedryl, which makes sense since Fiorinol is essentially a sleeping pill with some Tylenol and caffeine.

 

Hopefully other patients fare better with these kinds of drugs as a substitute. Very disappointing experience for me.

1/13/11 7:54pm

I HAVE ALSO BEEN TRYING FOR THE PAST TWO WEEKS TO GET MY DR TO REORDER MY SCRIPT FOR MIDRIN. I TAKE IMITREX BUT DUE TO COST I ALWAYS TRY MIDRIN FIRST. WHEN THE NURSE CALLED ME TO SAY I NEED TO SEE THE DR AS THERE IS NO MORE MIDRIN AT ALL, I CRIED. HOW CAN THIS HAPPEN? MY WORLD IS CONSTANTLY GOING FROM BAD TO WORSE. SINCERELY A MEDICAL SOCIAL WORKER.

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By Teri Robert, Health Guide— Last Modified: 02/01/12, First Published: 12/13/10