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Myasthenia Gravis For support and discussions on Myasthenia Gravis, Congenital Myasthenic Syndromes and LEMS. |
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06-21-2012, 03:33 PM | #1 | ||
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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. |
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"Thanks for this!" says: | Mytelase_Alliance (12-25-2012) |
07-13-2012, 03:07 PM | #2 | ||
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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. |
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"Thanks for this!" says: | Mytelase_Alliance (12-25-2012) |
07-30-2012, 10:58 AM | #3 | ||
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New Member
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We are searching for other alternatives. Will keep you posted. |
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"Thanks for this!" says: | Mytelase_Alliance (12-25-2012) |
08-08-2012, 05:37 AM | #4 | ||
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Its a shame that they take known working drugs off the market, but do no research to replace them with better drugs.
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"Thanks for this!" says: | Mytelase_Alliance (12-25-2012) |
09-01-2012, 08:15 PM | #5 | ||
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I have never posted anything online. But, I have been searching the internet for my mom. She has been taking Mytelase also for 60 years. She thought she was the only one. Two days ago she attempted to refill her prescription and was told Mytelase was discontinued. She feels she has only 40 days to live. Has anyone heard of EN101 or Physotigmine? Scared.
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"Thanks for this!" says: | Mytelase_Alliance (12-24-2012) |
09-24-2012, 10:34 AM | #6 | ||
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I am also on Mytelase. Fabulous drug, changed my life. I am so miserable on Mestinon. I was finally diagnosed with gluten intolerance and my pharmacist pointed out that Mestinon is a bromide and it agrivates my gluten intolerance. Since Mytelase is a chloride it does not bother me. I wonder why doctors don't offer Mytelase to their patients having gastro issues with Mestinon/
Not only did my issues clear up but the medication works so much better. None of that roller coaster up and down. It just works all the time. Wonderful stuff. Okay. So the year supply Sanofi said was in the market is already used up. I did find a few bottles through Kmart a couple of months back You could try filling your prescription there. At the time I got my bottle they had some bottles left in their warehouse. It's always been hard to get that medication in my area. Luckily the medication is still being made in France. which means you can import the drug for your own personal use. I have investigated this. So far I have a verbal agreement from the FDA for an Investigational New Drug acception. (yeah, I know it's not new, it's a long story.) And I have a verbal agreement from Sanofi to accept the IND and import the medication. Currently I am waiting for my doctor and the pharmacy department at the hospital he works for to submit the IND and get all the formal approvals. Government and paperwork, I don't have to tell you how long that is going to take. My IND will only cover me. You will need to contact your doctor and ask him/her to submit an IND through the FDA on your behalf. I don't understand why the Myasthenia Gravis foundation isn't helping on this. I tried to get some help from them. they told me to just switch to Mestinon. When I told them I could't take it they recommended Prostigmin. I told the woman the FDA made that drug illegal three years ago. And that was all the help I got. I hope this helps you. I am only sorry I can't get a general IND for all the MG patients on this. I bet there aren't more then 20 of us in the US. |
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"Thanks for this!" says: |
09-24-2012, 01:22 PM | #7 | ||
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Junior Member
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Your message regarding submitting an IND to have Mytelase imported is extremely interesting. I have referred my doctor's office to it. Perhaps you could expand on your efforts & give some help.
-Should each person having an IND application submitted talk to the FDA to get their verbal agreement to accept it? Is there a particular dept or person to contact? -Should Sanofi be requested to accept any shipments? Would they hold it only for a certain person and/or pharmacy? -If your application is accepted is there a possibility of getting a general idea of the language your doctor's office used in completing the application? This could be quite helpful to others in their filings. Thank you for all your work, for sharing it and for giving some of us a ray of hope. PS-I will speak to my local MG chapter & see if they can get the national foundation to help in this matter. Quote:
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"Thanks for this!" says: | Interested (03-09-2013), Mytelase_Alliance (12-24-2012) |
09-27-2012, 08:59 AM | #8 | ||
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Junior Member
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I contacted the National MG Foundation today to see if they had made any response to Sanofi regarding the discontinuance of Mytelase. They have made no response and indicated that they have not heard from any Mytelase users expressing concern about the discontinuance. They took my information and noted my concern. I would urge other Mytelase users to call the foundation amd make their voices heard. Their phone number is 800-541-5454. I would also suggest that if you belong to a local MG Chapter to ask them to lend their support by contacting the National Foundation on our behalf.
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"Thanks for this!" says: | Mytelase_Alliance (12-24-2012) |
12-24-2012, 08:35 PM | #9 | ||
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Junior Member
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I am just beginning to work on this with my father, who is in need of Mytelase for his MG. We will also be following up with Sanofi directly and will share what we learn here. The IMD may prove to be the most reliable avenue, so we look forward to hearing more about your effort, and perhaps we can work together on this. I agree that the Myasthenia Gravis Foundation should get behind this effort with us and help facilitate this process. Let's continue to organize here and together perhaps we can have some leverage with the Foundation to request assistance with this effort. As you express, there are others such as the elderly who are not able to advocate for themselves. Hopefully our efforts will benefit not only ourselves, but those and others who rely upon this medication. Uniting our efforts, may be the best way to insure access to this critical medicine for us all. |
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01-22-2013, 01:42 PM | #10 | ||
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Junior Member
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Today I received a call from Santofi. At 2pm today, January 22, 2013 they are meeting to try and find a way to import the drug for all the patients who need it. So what do you need to to? CALL SANTOFI!!! 1-800-981-2491 They need your name. they need to know how many patients need the drug so they can import enough drug. This is NOT a done deal. Your call saying you need the drug will help those in charge see there is a need for this drug. So please get on the phone and add your name to the list. Or the name of your loved one. You need to say you need Mytelase, it seems many people are on it because they are allergic to Bromides, so no mestinon. that is my problem. And make sure you give your name and a contact number. I probably made that as clear as mud. Ask if you have questions. |
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"Thanks for this!" says: | AnnieB3 (01-23-2013) |
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