Mytelase discontinued in US
 

My housemate has Myasthenia Gravis. She was diagnosed in 1989. Several years ago when Prostigmin lost it's FDA approval, we switched to Mytelase. She has had excellent results taking Mytelase vs Mestinon and Prostigmin. We got word today that Sanofi has decided to discontinue the production and sale of Mytelase in the US. This will be devastating for my housemate. Our pharmacy has been able to track down a few bottles to get her by for a while, but eventually she will have to go back on Mestinon, which doesn't work well for her.

My question, is Mytelase discontinued worldwide? I know it has been popular in France and other parts of Europe. I would appreciate any info. Thanks!

Mike J

I read that yesterday too ... my daughter is on Mytelase because Mestinon didnt work fine for her :(

we're from Slovenia, Europe and get Mytelase from Sanofi,France ...

don't know what we're gonna do if she has to go to Mestinon :confused:
if I get any information from her nevro, I'll let you know:hug:

You might want to contact some Canadian pharmacies.

I read a letter online saying only in US?
https://docs.google.com/viewer?a=v&q...UstXC5Fw7Rverg

It is unclear to me if this means EVERYWHERE?
Have you called Sanofi here for details?
Tel: 800-981-2491

Thanks. I did check a few Canadian Online Pharmacies, but since their source is Sanofi US, Mytelase is listed as "not available".

Mytelase was never widely prescribed here. (I wish I knew why. It seems to be far superior to Mestinon.) Her Neurologist was not even aware of it when she asked about it. Her pharmacy has always had difficulty getting it.

From what I researched online, it appears Mytelase is discontinued in Australia, Germany and the US, but is still available from Sanofi France, Hungary, Czech Republic, Poland, Sweden and from Ifet in Greece. (I have no way to verify this nor do I know what Sanofi plans to do in the future.)

The FDA would allow us to purchase 90 day supplies for personal use from outside the US, but I have found no sellers that would provide it. (Still researching that possibility. Most "online pharmacies" only deal with popular and generic drugs.)

I discovered Mytelase a few years ago when Prostigmin lost it's FDA approval here in the US. (My housemate took Mestinon with Prostigmin at that time.) While Prostigmin is still available here, since it is no longer "FDA Approved" insurance won't pay for it. Researching the history of Prostigmin, I discovered that Mytelase was basically a better version of Prostigmin. It has definitely been good for my housemate.

We will make some calls today and I have plenty of e-mails out. I will report back as I learn more.

If Mytelase is an OLD drug...it was probably grandfathered into the FDA approval process. What the FDA does is go thru old drugs now, and require them to apply with new applications to show efficacy and safety. Guaifenesin for example and even levothyroxine had to go thru this process not to long ago.

When a drug doesn't have the consumer use base, to provide the incentive ($$$) drug companies drop the product instead of applying. The link to Canada and Australia suggests and FDA thing since they typically follow the FDA, here.

This sounds like a bummer for you. I certainly hope you find
what you need. I'd still call Sanofi to find where to go next. They might help you or tell you more.

Mytelase is old but it is fully approved and has been kept current, just like Mestinon. Prostigmin was grandfathered because it came to market before the FDA was founded. The FDA has a mandate to remove grandfathered drugs or have them go through the current approval process. This is why Prostigmin is no longer approved. It would cost more to go through the approval process than they would ever make back in sales.

Actually in the case of Guaifenesin, the original formula was approved, but the time-release version was not and faced removal. The first company that filed for it's approval got the exclusive rights to make it.

My housemate did talk to the Office of the Deputy CMO at Sanofi this morning. She is hoping for a call back from the Deputy CMO. She also found a Canadian Pharmacy that regularly imports from France. They are checking on Mytelase.

Mytelase
 

I've been on Mytelase for about 60 years (or however long it's been available). I called Sanofi and didn't get much help except that it is being discontinued. I dread the prospect of switching over to ? Mestinon?
I'll watch this board for any news or actions that can be taken. I really didn't know whether I was the only one that still used Mytelase.

mestinon vs mytelase
 

I do not do well on mytelase and have taken mestinon for over 40 yrs. The cost of mestinon is astronomical in the U.S. I wish I could take mytelase, 1/3 the cost. Good luck, I'm currently looking for help with the cost of mestinon.

Just for your information, Mestinon (brand, no generic) is sold here in France or in Belgium for 0.40 US$ per tablet...
Maurice.

I would try and find a French pharmacy to order from and hope it makes it through customs. Just don't order too large a quantity lest they think you're dealing something and I've heard they don't tend to stop people's personal meds. My guess is the worst that'll happen is they confiscate it and you're out the money you paid (don't quote me on that--I'm not a lawyer and don't want to get you sent to prison).