iheartcats

I've seen several business and pharmacy blogs about this. This is one of the business blogs from today:

On Monday, the US Food and Drug Administration announced a proposition to pull ProAmitine (Midodrine) from the market due to Shire (SHPGY) not conducting post-approval studies to prove that the drug has a benefit.

Midodrine is currently the only FDA-approved drug for Orthostatic Hypotension. It was approved in 1996 as part of a shorter approval process under the condition that Shire conduct post-approval studies. Midodrine never was a big seller for Shire, and post-approval studies were never conducted. Midodrine was bringing in around $60M/yr as of 2005. FDA stated that around 100,000 patients filled prescriptions for brand or generic Midodrine in 2009. Take note that if the FDA withdraws the medicine's approval, generic companies including Mylan Pharmaceuticals (MYL), Impax Laboratories (IPXL), and Novartis (NVS) unit Sandoz must stop selling their generic versions of Midodrine.

The company that benefits from this decision is Chelsea Therapeutics (CHTP). Chelsea is developing Northera (droxidopa) for the treatment of Orthostatic Hypotension, with pivotal phase 3 trial results due in September.

Furthermore in Chelsea?s favor, Needham & Co analyst Alan Carr said the FDA action could help:

"The potential removal of midodrine may create a greater market opportunity for Droxidopa in the U.S.," said Carr in a research note.

If Midodrine is removed from the market, and Chelsea?s Northera study (Study 302) succeeds, the stock should most definitely be higher than it is now (if stock price rises to market potential, $6-$7 is very possible).

There is a lot of chatter and several news articles about dwindling supplies for dialysis patients and nursing homes. I don't think stockpiling is going to help.

Firewatcher - I'm borrowing your information for the Consumerist comments (about Chelsea)...I looked it up on Google and it's legitimate information! Thank you for posting. I'm not naming you or anything, just sharing the information.

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

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

Yeah! It has some coverage, at least.

I have a feeling many insurance companies won't cover a drug on clinical trial (the expanded access program). It also says if there is not enough supply it can go into lottery.

http://www.fda.gov/ForConsumers/ByAudience...s/ucm176098.htm

Basically, it's gamble if anyone can get it at that point or not so yet another stress for many of us.

The letter from Shire:

Dear Ms. X:

Thank you for your recent medical information inquiry regarding ProAmatine. We understand that you have requested information on ProAmatine discontinuation.

Shire will be discontinuing the sale of the branded drug, ProAmatine, in September 2010. Shire has made a business decision to discontinue the sale of ProAmatine. This action is not the result of any safety or efficacy issues regarding these products.

We are sorry that this action may be affecting your treatment plan. Please talk to your physician as he/she is most knowledgeable about your medical condition and can provide you with the most appropriate medical advice and guidance.

This information is supplied as a courtesy in response to your inquiry. It is not intended to recommend any indication, dosage or other claim that is not covered int he ProAmatine package insert(s).

Please discuss further questions with your physician or health care provider. He or she knows your medical history ans is in the best position to give you appropriate information about your medications.

Sincerely,

Shire Medical Information

I just wrote the FDA. From my understanding, there is no other drug that really does what Midodrine does!

It's so costly I can't afford it outside of insurance - and my refill isn't due until in September. I guess I'll get as much use out of what I have. I don't know any alternatives yet but maybe others can share what they do (if they don't use Midodrine) and talk to my original doctor who placed me on Midodrine.

My message directly from Shire says they will be discontinuing ProAmatine in September 2010 as a business decision. It goes on to say they are sorry if it is affecting my treatment plans.

Does this mean generics will be discontinued, also?

I am having an anxiety attack.

You can contact them here: medinfoglobal@shire.com

Would you mind posting their original message--the one saying that they are discontinuing ProAmatine-- here? Or can you send me a private message if you don't mind? I think I want to talk to my doctor about this... Tks.

The PDF they sent doesn't allow copy and paste. I will type it out later tonight or in the morning for everyone.

My message directly from Shire says they will be discontinuing ProAmatine in September 2010 as a business decision. It goes on to say they are sorry if it is affecting my treatment plans.

Does this mean generics will be discontinued, also?

I am having an anxiety attack.

You can contact them here: medinfoglobal@shire.com

The LA Times has a write-up too:

http://www.latimes.com/health/boostershots...6,0,53066.story

It says the FDA will revoke approval if it does not hear from Shire in 15 days and the generic manufacturers in 30 days.

Devastating to us POTS folk...I really won't know what to do!

I would appeal, too.

I haven't had a TTT as I was warned insurance companies like to deny them.

Well this is bad and scary news.

This one really helps me function and get going in the morning. I really thing it's integral in me being able to work, too.

Any ideas how long this could take to be 'pulled?' I can't believe they'd pull a drug out from people who really need it. It's only used by 100k people? Then of course it's very small and going to be used for very specific conditions in a small amount of people.

Thanks kindly everyone. I feel much better about the results now and will continue on my Seasonique.

What kind of doctor is this???? You can not measure estrogen levels while the woman is taking BCPs. I am a nurse midwife - geez. Please tell me this is not an ob/gyn!!! Tell him you will consult with a gyn - who will laugh their head off!!

Louise

I talked to my doctor and he said it could be menopause (I am really young for that - but it's not unheard of) or it could be the Seasonique.

To do another blood test, I'd have to go off Seasonique and I don't want to - my POTS is somewhat behaving and I'm not shaking the boat as the low Estrogen isn't a 'huge deal' at this point.

Has anyone experienced really low Estrogen because of Seasonique? I was on Mirena and went right to Seasonique and don't really have a period anymore.

Not an OB/GYN - just my primary. So that's what it is? My Seaonique?

I talked to my doctor and he said it could be menopause (I am really young for that - but it's not unheard of) or it could be the Seasonique.

To do another blood test, I'd have to go off Seasonique and I don't want to - my POTS is somewhat behaving and I'm not shaking the boat as the low Estrogen isn't a 'huge deal' at this point.

Has anyone experienced really low Estrogen because of Seasonique? I was on Mirena and went right to Seasonique and don't really have a period anymore.

Hello everyone,

A recent batch of blood tests came back (fairly normal, metabolic panel/CBC/etc. is OK).

The person who read my results said the Estrogen (I believe it was testing my estradiol) was 'undetectable.' He paused for a minute and I said what does this mean? He said it looks like it was below 20 so listed as 'undetectable' - I asked if this was an issue but he said it just said 'undetectable' but it wasn't highlighted as out of range.

So I left a message with the Doctor and went online. It looks like a normal range can be 50-400...but it should be detected in a woman in her 30s. It usually doesn't drop to below 50 until around age 50 (this is all 'in general' of course).

Does anyone have experience with this? I am not underweight (in fact I'm a bit opposite of that!), I eat decently, and I take Seasonique Lo-Dose Birth Control which is Estrogen/Progestin. Can it be affecting my POTS at all?

I feel better on the BCP then I did on Mirena (Mirena just was bad for me).

In general, my POTS has been better on my meds lately, but I do have more fatigue than usual.

I get them on occasion and it's so annoying. No idea what triggers it - out of no where I'll wake up all yucky and sweaty and then it won't happen for days (even weeks).

But it's not like 'exercise' sweat...it seems different, if that makes any sense!

I remember having insomnia issues as a kid. I don't know how normal that is...or if it could have anything to do with this.

Can these heal or if you had sleep apnea as a kid are you pretty much forever damaged?

Is it worth getting tested now for apnea?

Thank you everyone!

I will contact my prior doctor about this. Hopefully we can get something worked out soon.

Ladies and Gents - I'm still job searching and interviewing. The market seems to be picking up as I've had more nibbles lately.

Many of the places I talk to are 'downtown' so I'd have to drive and park. I can't do the train in my current location because it is always full and if you can even get on, it's standing. That's much harder on me- crowded and standing in the morning would do me in. Driving is fine for me as I'm sitting down and that keeps my POTS under control.

I had disability plates for work in my prior state. I get the feeling that doctors where I live now don't like to give out placards. But. There are bad mornings for me with POTS (as you all know) that to make it to work, I need to park close to avoid a long walk. For my health, for my safety, to have an income, etc.

I don't use the placard when I don't have to. I rarely use it on errands (unless I'm feeling awful). It's for my safety and security to be able to make a living. I don't run errands in the morning...but you don't have a big choice when you have to be at work.

I'm overweight (working on it) and I really want to emphasize to my PCP I'm not lazy. Any tips on approaching this with him when I get a job (or close to getting a job - I know it takes a bit to get the placard)? I assume I could have him call my prior doctor in the other state to verify it is crucial in helping me work. Even if I don't have to always use it, it's there if I need it. POTS isn't predictable.

Thanks kindly.

Sometimes it's like a night of partying without the fun of partying! ANS Hangover!

I am going to buy a case of V8 cans at Costco and try the morning trick of gulping that down and taking my meds. Currently, I take my meds with milk, lie back down for 30 minutes, and get up about 30% better than I was feeling.

That at least allows me to plod around and get ready in a bit better state. It'd be lovely if the V8 could help a bit more. You guys understand how a 30-50% 'improvement' in symptoms can make or break you sometimes.

I just tell myself middle-aged is over 40 now. Mine hit in the 20s so I can keep hope alive!

So far I'm just going to my PCP for 'maintenance.' The thought of looking for a local Cardio makes me anxious, so I know how it can be.

You seem happy with who you found so far...I'm glad you kept the hair!

Dana - I'm glad someone understands how I feel...I am annoyed with myself for acting like that (and I knew crying would be no good for POTS!) but I just couldn't hold it in any longer!

Maybe we reach a tipping point and just have to vent. You never learn how to deal with a chronic illness in life, do you? I guess we do as best we can, at least I try to tell myself that to feel a bit better.

I've just felt extremely frustrated and angry about having POTS (on top of a few other things as many of us deal with).

I didn't mean to pick an argument with my loved ones, but it ended up that way. Then I was just so frustrated and upset I took a shower and just cried and cried...like I was an angsty teenager or something. I just felt so mad that I have a condition like this and there isn't a lot I can do to get rid of it. To the point of yelling at it to 'go away, just go away.'

I just never felt that strong about how much I dislike being ill, if that makes sick. And then having a good cry in the shower makes me feel like I'm 15 and can't control my emotions.

Of course today I'm getting over the 'flare' a shower plus crying caused. Thanks POTS. Sometimes I just feel so alone dealing with this and I can't believe I got that out of whack.

Maxine,

I'm glad you are feeling better about the bite. Samantha is a doll...she was just scared. Poor kitty. At least you know the cat who bit you (she's 'clean', has her shots, etc).