... produced. Is this true? Who is the manufacturer and why did this happen? What is the name of the generic of Mebaral. I've been on these drug since I was twelve.
All of a sudden my doctor changed discontinued my Mebaral and said that Mebaral has stopped being?
- Posted:
- 15 Dec 2009 by awergjklpjfnmhdcwedd
- Topics:
- mebaral, epilepsy
Details:
Answers (1)
19 Dec 2009
I have done a lot of research about mebaral recently. Here's what I have found. Yes, Mebaral will be available. Only in 50 mg or 32 mg tablets. No 100 mg. at least for a while. The generic form--mephobarbital has been discontinued by the manufactuer. A little interesting history about the drug makers. Sanofi- Synthelabo Inc was the sole maker of mebaral before 2003. In August 2003, US company--Ovation Pharma bought the rights to make Mebaral from Sanofi. Ovation was purchased by the Danish company H. Lundbeck A/S in March 19, 2009. Lundbeck decided to stop production of Mephobarbital (the generic) summer 2009. Then, they claim to have a production problem making the 100 mg of Mebaral this fall. I talked with a rep. of Lundbeck and she said they will continue to make the 50mg pill and hope to have the 100 mg available in early 2010. No definite date was given. Lundbeck has a US office in Paramus NJ--phone # 201-261-1331.
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Today my doctor gave me a letter he had received from Lundbeck stating Mebaral would not be available after 2011. Due to government regulatory restrictions the company would no longer be able to manufacture Mebaral. I have used this since 1963 to adequately control seizures. I am distressed to learn it will no longer be available.
Same here, Lundbeck does not care. They will not be making it period. The generic is no longer made. I pay $200 per month for the Mebaral, and Medicare does not cover a thing. Help me if you can.
Mebaral is a victim of the FDA approval process and age. It's rarely prescribed anymore, and I (at age 50) am apparently on the young end the patient spectrum that use it. Between that and the FDA process, Lundbeck has opted to discontinue manufacturing it. Supposedly there is enough to finish out the year here in the US. I am also a longtime user, since age 16 or so, with no seizures since 1989 (as long as I take the meds!) so I am now finding a new med. Supposedly there are tons of great new meds out there, improvements on the old Dilantin and barbiturates used up til now.
I am also checking out the Epilepsy Foundation site for more chatter. Good luck!
I too have done my research, and the us gov. says it will not allow Mebaral to be made. It was approved prior to any strick testing requirements. I know it works very well. We are living proof on the human testing. I don't mind being a ginny pig, just make sure I don't have any more of those terrible seizures, and that I remain the "person" I am. Please!
I have applied for the individual drug use application through my doctor to try and acquire Mebaral through a distributor out of the country. I am now researching pharmaceutical companies in other countries who may still make the drug, but with out the help of my doctor. You have to do as much research as you can and if possible we need to put group together to stop this or find an alternative plan. I spent the last year trying to change drugs. I tried both Keppra and Topamax but both made a very controlled situation, worse. Mebaral is a drug I've been taking since I was a baby and it has worked. I have spent the past year and 1/2 researching the possibilities. I am now talking to the Epilepsy foundation to seek help because it is life or death at this moment for me and I'm sure many others. I would love to know what everyone else find out about this.
I too would love to research to maintain the mebaral. We should have enough people from different sites to maybe do something. I "FEAR" trying to go to any other drug. Caroloski
I too would love to be a guinea pig for the FDA, as I have been on this medication for over 45 years with no seizures (if I am on the medication). I just called Lundeburg and they said it was a corporate decision not to manufacture Mebaral anymore. They also stated that at this time no one else has purchased the rights to manufacture, therefore they are not aware of any other way to purchase mebaral at this time once "there supply is depleted". Talk about frustrating! I called a different #-1-888-514-5204. Good thoughts to everyone. Please keep in touch re: successful transitions to other medications. Thanks!
Please let me know if anyone has any success in an alternate drug , or a pharmacy over seas that may make this drug. My Dr . Suggested I contact 2 pharmacy's in Canada to no avail. Like the rest of you - I have been on this drug for over 25 yes and seizure free. Tried phenobarb a yr ago , in anticipation of this and had disastrous results .
I have made the transition to Zonegran. It took about 10 wks. I have the shakes yet, but that is expected, been on Mebaral for 42 yrs. The Zone is cheaper, not a barbituate, and have not had a seizure yet, knock on wood, say a prayer for me. pls. Carol
Please keep us posted as to how your transition continues. I will send good thoughts your way. I am so fearful to try and transition that I am really trying to find out from you brave souls that have ventured into this scary zone. I think it is horrible that Lundebeck flicks at us to move on over and update our medication. I too would love to be an FDA guinea pig for mebaral. Thanks for your updates.
Here is a copy of the email I received from Lundbeck:
Thank you for contacting Lundbeck Inc. (Lundbeck) regarding the Mebaral®. Please note that Mebaral has been discontinued.
Mebaral was introduced in 1935, prior to the Food and Drug Administration’s (FDA) New Drug Application (NDA) process that was introduced as part of the Federal Food, Drug and Cosmetic Act of 1938. Recently, the FDA informed Lundbeck that Mebaral can no longer be made available without the submission of an NDA followed by FDA review and approval. This process takes several years. Unfortunately there is not a large enough Patient Population that uses Mebaral to meet the study requirements necessary to file an NDA. Because of this, Lundbeck cannot meet the FDA’s requirements and we are unable to continue manufacturing Mebaral.
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We appreciate the very difficult situation you face with regard to the upcoming Mebaral discontinuation and we regret that, due to regulatory changes, we will be unable to continue to make Mebaral available in the U.S.
We know that some patients have received Mebaral for many years, which is why we’ve communicated this situation to wholesalers, physicians and patient advocacy organizations well in advance of our expected stock depletion at the end of 2011. Lundbeck notified Physicians and Pharmacies of the discontinuation as soon as we received the FDA’s decision in January 2011.
Due to the limited remaining Mebaral supply, we encourage patients to work with their physician to transition to alternative therapies rather than starting a new course of therapy with Mebaral. Your Physician would be the best resource to discuss a medication equivalent to Mebaral or other potential alternative therapies currently available, and we encourage physicians and their patients to discuss these options so that patients can be transitioned to an alternative therapy before stock is depleted.
Again, we deeply regret the trouble this development may cause you. Please don’t hesitate to contact me if you have additional questions at (866) 402-8520 from 8:00 a.m. to 5:00 p.m., CST, Monday through Friday.
Sincerely,
Priscilla Cervantes
Medical Information Coordinator
Hi Kgate: you mentioned that you had problems using phenobarb. Can you explain? How did you transition--dosage--milligrams mebaral to phenobarb? Symptoms--seizures?? It seems that going to phenobarb is a likely transition strategy but not if it doesn't work. Thanks for you comments.
So ... I am in the transition "weening" off period from Mebaral. Primadone. Is anyone on it ? Do you have to feel stoned if you're an epileptic , or is this just my body's way of transitioning. Not liking the feeling.
Like most of you, I have been on this medication for many years. Clearly, we have all taken it with no adverse effects, and at one time it was certainly taken by thousands more people who are taking it now. It was apparently on the list of "grandfathered" drugs until recently, according to the letter received from the manufacturer previously posted here. So I'm wondering who at the FDA made the decision at this time to discontinue it from the grandfatethered drugs and cause all these problems for us. Although I'm not optimistic about any positive results, I'm going to try to find out from the manufacturer how many people, nationwide, are still taking this medication. Then I'm going to contact the FDA and see how this decision was made. And then I'm going to write to the head of the FDA and copy my congressmen, the surgeon general, and anyone else I can think of regarding this decison.
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I feel like this is important to us, that it's a decision that shouldnt have been made, and that it's important to stand up for ourselves. I'll keep you posted on anything I learn.
Have you had any further luck since your post in Dec 2009? Please advise if you have transitioned to any other drug and its effects? Thanks!
Planning to try to transition to phenobarbital--has anyone done this and why did it not work, if it didn't? My doctor seems to think it would "feel" about the same as Mebaral, since it is chemically similar.
Google the name Ovation and you will be surprised at what you see. I have taken mebaral since 1975 in the 32 mg dosing 2ea BID and as of 12/19/2001 I am now on Primidome at 250 mg cut in half at BID. I managed to find some Mebaral 90 miles away and I am keeping it in reserve just to see what happens with the Primidome.
I too have been taking Mebaral with great sucess for over 40 yrs. I cant believe the FDA or whoever can do this. I think its time for some legal action.
are they nuts or greedy? i was toldonly 800 people use this drug. it works for me and now i am told in december 2011 too bad by lundbeck. only enough until february2012 and they will be no good after march. how does this happen in the united states? what about people seizure free for 30 -50 years. this is cruel we were the research and now some of us may die but lundbeck will not lose money. the fda better start looking at aspirin. first doctor do no harm. where are the physicians in our fight were we just car payments to them?
are they nuts or greedy? i was toldonly 800 people use this drug. it works for me and now i am told in december 2011 too bad by lundbeck. only enough until february2012 and they will be no good after march. how does this happen in the united states? what about people seizure free for 30 -50 years. this is cruel we were the research and now some of us may die but lundbeck will not lose money. the fda better start looking at aspirin. first doctor do no harm. where are the physicians in our fight were we just car payments to them?
Well, I mentioned earlier, I was trying Phenobarbital--that seemed very very sedating (strange, since Mebaral is supposed to be similar). Now I'm going to try weaning off Mebaral altogether, since I only have ever had one grand mal seizure (in 1981) and my problem is mostly myoclonics--I am not sure that is a big problem, since I don't lose consciousness during those. I have JME.
Thank you all for this very useful information. I am writing because my great uncle who just turned 93 has had his seizures under control since the 1940's with mebaral. 2 years ago, he was hospitalized because the levels of his 2nd medication was too low. While in the hospital, his sister discovered the staff had not given him his mebaral dosage for about 5 days even though each day she asked and they told her yes. Consequently, he suffered seizures he hadn't had in almost 50 years. He was immediately given phenobarbital because the hospital didnt have any, although his sister ran and got his supply from home. His condition worsened and it took getting him off the phenobarbital and back on mebaral. He was suffering seizures for 7-8 months, then night shaking. Finally, his condition is better and now is faced with this situation. If anyone has any follow up information about either obtaining mebaral, lobbying the FDA for grandfathering, please post.
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I am deeply concerned for my great uncle who is otherwise in great condition and his 80 year old sister who takes care of him as a change in seizure medication is delicate for anyone, much more for a 93 year old.
Okay! We are all in the same boat. No MEbaral. From what I have read, there are about 800 of us who are still alive and have survived from this unholy drug. It seems as if this should have been grandfathered in by the fda. I am 72 and have been taking this drug since 1958. You do the math. It is about time we do something about this unfair practice of the fda and Lundbeck... I don't like the idea of getting kicked to the curb. I think we should make our doctors aware of our plight and the Epilepsy Association in both our towns and states... They are supposed to working for us... well lets see if they can put there good intent where their mouths are?
I am 54 y/o and just found out yesterday that mebaral was being discontinued. I have been on this drug since 1971 and have been seizure free since 1989. I am "scared" about having to work with another drug since I finally got the right dosage. Any suggestions?
lundbeck told me only 1 other person called! call lundbeck and the fda. we do not desrve this. WE were the research and it went well. let's start sending our medical records to both and hold them legally responsible for what they are doing in court.
I too use Mebaral to control my seizures and migrain headachs. I have used this medication since 1967 and now 72 years old. It is a living hell to have to live with seizures. Why is the FDA giveing those who use this medication to live normal and productive live a death sentecense basicly by stopping the manufacture from producing it? That is an infringement on our right to live a better life. It is still made in the 50 and 35 mg., so don't give up on receiving this medication. When I spoke to the manufacture it is not that they who want to discontinue it, it is the distributers of the drug store who do not want to stock it but if your doctor insist on you having it and the your drugest is willing to request his distributer to get it for them, you still will be able to get it in the lower dosage as of 2012. Don't give up on this.
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Let everyone who use this medication wirte to manufacture Lundeck, in Paramus , NJ and let them know we need this medication and maybe it will make a difference and get it back on the market. Or better yet call them the phone number is 201-261-1331, also request that your doctor call this number. Let me know what you find out please just put Mebaral in the subject line and I will know it is someone else who needs help. The first time you email me it will go in the Junk box but with the subject line I will move you to the inbox and you will not be deleated. Thanks.
I think we all need to get a petition going with signatures and send to the FDA plus open some kinda forum online where we all can chat about latest developments. Anyone interested?
Ratig, yes I am.
Ratiug, please contact me. Apadams@me.com
See my user name for site info. We have dedicated this site to all of you that have been affected by the discontinuance of Mebaral.
For more info or to continue discussions on this topic visit www.mebaraldiscontinued.com.
None of us can make a change by ourselves... we must all come together and be heard. Please!!
We were told that Lundbeck still has some Mebaral in stock, if you need it, your Dr. will need to write a prescription and call Lundbeck's Specialty Pharmacy (Mebaral Support Center): 800-310-5308. When he/ you call, it will probably go to voicemail. They will call you back the next day. Talk to Ja Tam (not sure how to spell her name, my dad talked to her). They will not ship anymore Mebaral after March 15th.
I was just contacted today, 3-12-12, that Mebaral will be discontinued and will not be able to get anymore after 3-31-12. My pharmacist apparently called my Family Practice Doc today to notify. My daughter has been on meboral for over 20 yrs with no increases needed. Meboral in combination with 2 additional antisiezure drugs have been her saving grace. She has been siezure free for 20 yrs. I am in panic mode. I have to come up with a neurologist, as my dtr's retired, and wasn't replaced due to being seizure free. Meds/labs were monitored by The Family Practice Doc. Why such short notice? Does anyone know where I can get more Meboral? I don't have enough of the med to properly wean her... Thanks for any advice!
My Grandmother was given mebaral since she was a teenager and Lundbeck discontinued her medication. We only found this out when we went to fill her perscription, the pharmacist said that this medication was discontinued without any knowledge or way to know of this. The neurologist had perscriped phenobarbital and now she feels drunk all the time and is afraid of having a siezure and she is 63 years old. When we confronted the neurologist about this he said that he had knowledge of the medication being discontinued (the mebaral) and he never informed us until just the other day when we were trying to find an alternative medication. Why doesn't anyone say anything or post a sign about this and why do doctors never tell the patients until the last minute?
I know someone who has been on this drug for 40 yrs. Well he is off from it now due to no longer making it. He is on somethingelse and is haveing a rough time with seizures. This is terrible for someith that has been there for people and now it is not. Bad Bad.
will this drug become available and if yes how can we get it. We need it.