Fda Withdrawing Proamatine/midodrine?!

[Stace915]

I am going to email them... I will wait until later in the evening so I am slightly less brain-foggy and I can write an email that makes sense and sounds intelligent.

[brownsea]

i get midodrine imported from the us, have enough till christmas. i really dont know what i will do without it, been on the pots concoction for just over a year now and i feel a lot better than i did at least i can function to some capacity each day.

fingers crossed everyone. xxxxx

[iheartcats]

http://consumerist.com/2010/08/fda-tries-t...ssure-drug.html

Yeah! It has some coverage, at least.

[iheartcats]

I just spoke to my original doctor in Chicago who put me on Midodrine and she knows it made a difference in my quality of life and how I function. She prescribes it to many patients.

There is no alternative and many people on it are upset and worried. I wonder what we can do? Should we contact news outlets? It is greatly going to affect quality of life for many of us and the drug is safe and effective for OI.

[Tuesday]

I'm not sure who to contact, but I am going to write letters to my congressional representatives, at a minimum. I have already contacted the FDA. I wonder if there are other consumer advocates groups that could be helpful?

[Tuesday]

Here is the message I am sending to my congressmen, in case anyone wants to copy or use something similar:

"I am writing regarding the recent decision from the FDA to withdraw the hypotension medication ProAmatine (Midodrine) due to failure on the part of the maker to prove its efficacy. This is the first time the FDA has enforced such a case. The drug maker has decided that the bureaucracy is too much and will be discontinuing the drug next month.

This medication is used to treat low blood pressure, and is the only drug available for this purpose. There are no concerns about the drugs' safety. I and many other patients rely upon this drug to live a normal life. Without it, we are unable to stand or walk without passing out, cannot hold jobs, take care of our families, or care for ourselves.

There is no question about the safety of this drug, and its benefits are life-changing. Whether the drug is effective for a given patient should be between the patient and their doctor, provided the drug is safe.

Without access to this drug, hundreds of thousands of patients are facing the prospect of losing their jobs, their ability to care for family, participate in hobbies, and function without disability.

I strongly urge you to help your constituents fight to retain access to a medical treatment that is vital to maintaining their independence.

Thank you for your service. "

[Rachel]

Wow. How sad! I hope the FDA changes their mind on this one. Midodrine is one of the very few medicines that improves my quality of life just a little bit. I know it helps so many of us! And from what I've read on side effects of the medication, it hardly has any! Compared to most of the meds out there, midodrine is pretty benign as far as side effects go.

Thanks to those of you who have posted ways to contact the FDA and and Shire regarding this.

Rachel

[Tuesday]

It's a long shot, but I used to work for several lobbying groups. I am contacting some of my former bosses and coworkers to see if they know of anyone else I can contact to get this issue out in front of people.

[potsgirl]

Ok, this may be a stupid question, but when I was first diagnosed, they put me on Florinef and Midodrine, neither of which worked for my OI. What about Florinef? Can it perform some of the same functions as Midodrine?

[desiree942]

I sent a note to Shire and the FDA BUT another thread posted a response from Shire that said they were going to discontinue the drug in September 2010 for business reasons. The generic companies would also have to cease manufacturing. So I'm wondering how much good lobbying the FDA is going to do if the drug company is saying they don't want to continue manufacturing the drug?! I remember Dr. Grubb told me there is no $$$ in low blood pressure, hence the lack of research and meds.

I'm super bummed. I was on Midodrine for a few years and now I take cymbalta and only use midodrne "as needed" which is about 1x a month for periods of extended standing. It has been a security blanket for me.

[mkoven]

I take both and believe their effects are synergistic. Florinef is more of a blood volume expander, though it might help constriction a bit. I am considering upping my dose of florinef if i can no longer get midodrine... not sure...i like how fast acting midodrine is.

[nmorgen]

I'm thinking about writing my Congressman, even though I don't take the drug. I think what they are doing is just wrong, and it doesn't make any sense.

[lalalisa]

Wow, this topic is raising my blood pressure. Too bad it won't last. I need Midodrine!!

[erik]

Hmm. As a long shot, one can hope one/some of the generic manufacturers sponsor the "phase 4" studies and thereby gain/share a 3 year exclusive period. That at least gives some incentive to try a study (or "find" supportive data somewhere). That 3 year exclusion is not available to the original company (who apparently already had their original 5 year exclusive period). It's not a huge market but at least they'd have a lock on it and might stand to profit overall. After that 3-year period, back to having generics (which aren't very cheap anyway) and continued availability. Only thing better would be if the FDA magically "looked the other way" and ignored these regulations designed to protect us all.

(It would be cool if Shire had some helpful info that they could sell to one of the generic makers to jump start their trial).

The "expanded access" or "compassionate use" status sounds very burdensome... and insurance coverage would be lacking... and who knows how liability insurance looks on such actions by a doctor!?!

Sounds like "orphan status" doesn't change the requirement for the same approval process, it just opens up tax benefits and/or outside funding for the study (provided fewer than 200K folks in the US have the condition... which is not the case for "OI" in general, but it is reportedly the case that only 100K patients are prescribed midodrine specifically).

[firewatcher]

Scott Hensley at NPR:

"Update: Shire said in a e-mail to us that it is "currently reviewing" FDA's proposal. The company said it "did conduct and complete the trials that the FDA required; the FDA viewed these trials as inconclusive."

Shire told the agency and doctors "earlier this year that it is withdrawing" ProAmatine and has offered to assist the makers of the generic versions "by providing them full access to Shire's data" if the companies want to conduct the studies FDA wants."

The generic companies have 30 days to respond. Shire told the FDA (and apparently the doctors) a year ago that they would stop making it, due to lack of profit.

[Noreen]

Thanks for the update.

I guess energy should be focused on generic mfg.

[Noreen]

You know it seems Shire either overestimated the market or we lost out by Shire not getting tax incentives for clinical trials by not applying for Orphan Drug status. According to Wikipedia the status applies when patients are under 200 thousand.

Anyway you look at it, we lost out as we lose generic availability and our insurance companies kick up a fuss. The Clinical trials for midodrine are available at http://clinicaltrials.gov/ct2/results?cond...+Orthostatic%22

[wareagle]

I contacted the generic company that supplies my Midodrine (Mylan) yesterday via e-mail. I have yet to recieve a response. At this point I guess that's the best thing to do....contact these companies that manufacture the generic and hope one of them will pick up the ball on this.

[Noreen]

The new drug Droxidopa

http://www.entrepreneur.com/tradejournals/.../159502891.html

was granted Orphan Drug status in 2007 guaranteeing Chelsa Pharm exclusive rights for 7 years.

We are left to wonder what financial impact this will have on us and the ongoing studies the VA is doing to study use of Midodrine in spinal cord injuries.

It will definitely be a money maker for the mfg. They completed Phase II research in June on use of it in fibromyalgia termed promising . Yet with the orphan drug status they willl guarantee sole use of the drug for 7 years, have had their clinical trials paid for and had FDA fees waived. You have to admire the chutzpah to get a drug approved for one disease entity while haveing a huge potential market in your other pocket.

How many people in Japan have OI to account for a 50 million dollar business?

[iheartcats]

I'm loving how Pharma is blatantly more about profit than helping people.

Anyway, we'll have to see if the generics will do anything. I emailed TEVA and haven't heard back from them yet. They are a very large generics company.

Has anyone noticed how costly the generic is? I've never seen such a costly medicine before. You think the generic manufacturers would be making some profit.

[mkoven]

I left a message with Dr. Fouad-Tarazi's nurse at the syncope clinic in Cleveland. I haven't seen them in a couple years, but I am technically still a patient. I imagine the withdrawal of midodrine will be an issue for many of her patients, and as a high-volume center, they must be strategizing. Curious to hear what they say.

[cnm1]

I emailed the FDA, Shire, and Mylan (the generic my daughter does best with). I will also contact my congressman. I can't tell you have much this scares me. My D was home bound for 5 years. With a cocktail of many drugs, she starts her PhD at Harvard next week. She can not function without it.

Louise

[MightyMouse]

Calling your POTS specialist doc is probably not necessary at this point--I can tell you definitively that, YES, they are strategizing. I have read numerous emails from most of the names you'd all be familiar with. Rather than clog up their phone lines, your time might be better spent contacting the FDA, if that's something you're inclined to do.

As to the specialist in the US who've been emailing with each other about this issue, when I get info on what they have collectively decided to do, I will share that information with you, to do with what you will. There are already wheels in motion with regard to some special committees working together to try to either pool data that may already exist or lobby the FDA to keep proamatine around using other means. There's no more yet, but I can tell you that certainly within cardiology circles, there's loads of POTS savvy physician's working on this.

It's possible that the generic makers may be able to take over, and they have longer than Shire to get data together (until at least some time into the end of Sept according to some of the emails I've gotten). Additionally, there are also special circumstances for what are called "orphan" drugs, where the FDA may let them continue in the market. It's possible that proamatine may end up there. Lastly, it may be available from overseas or Canada even if not here in the US, such as some of you do with domperidone aka motillium.

Seriously, clogging up your POTS specialist's phone line at this point doesn't have much value with regard to keeping the drug available--and uses up resources in their office that could be put to better use. If you're calling, however, to try to switch meds now in the event that the drug does leave the US market, that's another story.

[DancingLight]

This is devastating news for those of us who rely on this medication.

Nina, that is excellent advice and I am sure that our doctors are just as frantic as we are to find a solution!

I hope that something will be worked out...as I know so many of us benefit from this medication.

[Noreen]

Nina-

The new drug, droxidopa, has already been given orphan drug status in 2007. Makes it much easier for Chelsea pharm to pay for required clinical studies when the gov't foots the bill. It remains to be seen whether it will be released in Sept.

Would another drug for the same condition be granted that status? Unknown. The real problem for us is how long it takes us to get a drug that works and at a dosage that works. Droxidopa may prove to be an excellent drug given its mechanism but the studies are still ongoing as to dosage. How will it interact with other drugs is another question docs need to become familiar with.