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Lamictal - switch to generic lamotrigine?

Fri, 08/08/2008 - 18:27
Hi, everybody. I just joined this site yesterday. I saw a forum where a few people were discussing transitioning to generic lamotrigine (just released) from Lamictol. But now I can't seem to find the forum. I'm considering the generic switch and am wondering if anyone's done it yet, gotten advice on it, etc. Please help! (Or let me know where to find yesterday's forum! It's not coming up in the search.)

Comments

Re: Lamictal - switch to generic lamotrigine?

Submitted by apmast on Wed, 2008-12-10 - 06:38

Sorry to hear about it.  I have had nothing but success on generic Lamictal.  

Did you talk to your doctor about the generic before you switched?  If so, the decision includes HIM and is justified by his being aware that generics can be less effective.  This is especially true if he has other patients who took the generic and had breakthrough seizures.  In summary, it means that you should get your neuro to approve you to drive and he has the power to do that!!!  (especially based on a prior history of no seizures for 7 years).

However, If YOU made the generic decision without your doctors approval and that causes a seizure then you would probably not be approved by your doctor and would lose the driving priviledge.  I would advise ALL patients switching to generic to get their doctors "OK" beforehand so that they have some shared liability if  they do have a breakthrough seizure that would require a suspension for 6 months.

Cheers, Andrew

Sorry to hear about it.  I have had nothing but success on generic Lamictal.  

Did you talk to your doctor about the generic before you switched?  If so, the decision includes HIM and is justified by his being aware that generics can be less effective.  This is especially true if he has other patients who took the generic and had breakthrough seizures.  In summary, it means that you should get your neuro to approve you to drive and he has the power to do that!!!  (especially based on a prior history of no seizures for 7 years).

However, If YOU made the generic decision without your doctors approval and that causes a seizure then you would probably not be approved by your doctor and would lose the driving priviledge.  I would advise ALL patients switching to generic to get their doctors "OK" beforehand so that they have some shared liability if  they do have a breakthrough seizure that would require a suspension for 6 months.

Cheers, Andrew

Re: Lamictal - switch to generic lamotrigine?

Submitted by Dr. Roberts on Thu, 2009-08-27 - 19:23

After reading through some of the posts on this topic, I feel compelled to contribute, although I'm quite sure my comments will not be well received. Internet forums, after all, are the place where people with complaints tend to come together to comiserate. This is not remotely meant to be an insult to anyone here, the "internet forum bias" phenomenon exists for thousands of products, from medications to cameras. One must realize, however, that the information presented by lay people in these forums is heavily biased towards those who have had bad experiences with the product being discussed. People who love their camera (or medication) don't generally take the time to seek out an internet forum to find if others are similarly happy. However, those unhappy with their camera (or medication) will likely turn to these forums to seek out others with home they can share their problems. Forums are often the internet's "complaint department". 

In short, just be careful what you take away from here. You are not hearing from the tens of thousands of people who've had no problems with lamotrigine. You're only hearing from the vocal few that have (or think it's the drug).

I cannot think of another aspect of the practice of medicine that turns normally logical thinking physicians into illogical beings. That aspect is the concept of generic drugs and bioequivalence. There is more misinformation being propagated by healthcare professionals (even pharmacists) about this topic than I can sometimes bear.

The first is the concept of "generics can vary by 20% and more from brand name drugs." That is completely dead wrong. Generics vary by no more than brand name drugs vary among themselves from lot to lot, and that is about 2.5%. The 80 - 125% variance that's allowed is with regard to the 90% confidence interval. That's statistics, and since nobody understands statistics, they just relate what they think they heard, and that's the 80-125% variance. That does NOT mean the drug can vary by that much, it means the statistical test for bioequivalence at the 90% confidence level can vary by that much. That leaves VERY little room for the generic to achieve a different plasma level than the comparitor (brand) drug. Tablet press technology, normal handling, and the sensitivey of drug assays simple prevents drugs (brand to brand or brand to generic) of being any closer than that.

Think of this, however: miss one dose, take the medicine with food one day then empty stomach the next, smoke a cigarette, take interacting drug, or a myriad of other biological events and you'll get up to a 80% difference in blood level from day to day. Biologic variation is MUCH more likely to cause variance in plasma levels than who makes the drug. The FDA ensure that the drugs are very close, patient and enviromental biology will ensure the variance is more like 10-15% from day to day. This happens whether your're on brand or generic.

To make matters worse on the "generic vs. brand" front is the psychological effect (placebo effect) drugs have on patients. Every clinical trial reports headaches, sinus infections, muscle aches, etc. on placebo pills. The power of the mind. The perception the patient has on how (or if) a drug is going to work is a very powerful thing. If your physician has done you the huge injustice of suggesting that generics are inferior, then that's exactly what they'll be for you. Some disorders (depression, irritable bowel syndrome, fibromyalgia) have gigantic placbo effects, up to 50%. The active drug may only work 10% better than the placebo. If you think you're epilepsy drug isn't going to work or it's going to have side effects because it's generic, you may well fulfill that prophecy. Visiting this forum and hearing others confirm your belief just compounds the problem. It isn't the generic drug that's the problem, it's the misinformation and perception - a powerful weapon not unrecognized by pharmaceutical companies that pour money into agencies like the American Academy of Neurology and the Epilepsy Foundation to promote brand name drugs. Suggestions by these organizations that generic drugs may be unsafe are completely groundless and based on anecdotal information, not good science. Politics and money, however, have trumped common sense even for many physicians on this topic.

My intent was not to offend anyone, only to educate. Take this information like you should take anything you read on the internet, with a good dose of skepticim.  I'm happy to personally communicate with anyone and provide you with information from the medical literature and the FDA that makes my point here.

Thanks

 

 

After reading through some of the posts on this topic, I feel compelled to contribute, although I'm quite sure my comments will not be well received. Internet forums, after all, are the place where people with complaints tend to come together to comiserate. This is not remotely meant to be an insult to anyone here, the "internet forum bias" phenomenon exists for thousands of products, from medications to cameras. One must realize, however, that the information presented by lay people in these forums is heavily biased towards those who have had bad experiences with the product being discussed. People who love their camera (or medication) don't generally take the time to seek out an internet forum to find if others are similarly happy. However, those unhappy with their camera (or medication) will likely turn to these forums to seek out others with home they can share their problems. Forums are often the internet's "complaint department". 

In short, just be careful what you take away from here. You are not hearing from the tens of thousands of people who've had no problems with lamotrigine. You're only hearing from the vocal few that have (or think it's the drug).

I cannot think of another aspect of the practice of medicine that turns normally logical thinking physicians into illogical beings. That aspect is the concept of generic drugs and bioequivalence. There is more misinformation being propagated by healthcare professionals (even pharmacists) about this topic than I can sometimes bear.

The first is the concept of "generics can vary by 20% and more from brand name drugs." That is completely dead wrong. Generics vary by no more than brand name drugs vary among themselves from lot to lot, and that is about 2.5%. The 80 - 125% variance that's allowed is with regard to the 90% confidence interval. That's statistics, and since nobody understands statistics, they just relate what they think they heard, and that's the 80-125% variance. That does NOT mean the drug can vary by that much, it means the statistical test for bioequivalence at the 90% confidence level can vary by that much. That leaves VERY little room for the generic to achieve a different plasma level than the comparitor (brand) drug. Tablet press technology, normal handling, and the sensitivey of drug assays simple prevents drugs (brand to brand or brand to generic) of being any closer than that.

Think of this, however: miss one dose, take the medicine with food one day then empty stomach the next, smoke a cigarette, take interacting drug, or a myriad of other biological events and you'll get up to a 80% difference in blood level from day to day. Biologic variation is MUCH more likely to cause variance in plasma levels than who makes the drug. The FDA ensure that the drugs are very close, patient and enviromental biology will ensure the variance is more like 10-15% from day to day. This happens whether your're on brand or generic.

To make matters worse on the "generic vs. brand" front is the psychological effect (placebo effect) drugs have on patients. Every clinical trial reports headaches, sinus infections, muscle aches, etc. on placebo pills. The power of the mind. The perception the patient has on how (or if) a drug is going to work is a very powerful thing. If your physician has done you the huge injustice of suggesting that generics are inferior, then that's exactly what they'll be for you. Some disorders (depression, irritable bowel syndrome, fibromyalgia) have gigantic placbo effects, up to 50%. The active drug may only work 10% better than the placebo. If you think you're epilepsy drug isn't going to work or it's going to have side effects because it's generic, you may well fulfill that prophecy. Visiting this forum and hearing others confirm your belief just compounds the problem. It isn't the generic drug that's the problem, it's the misinformation and perception - a powerful weapon not unrecognized by pharmaceutical companies that pour money into agencies like the American Academy of Neurology and the Epilepsy Foundation to promote brand name drugs. Suggestions by these organizations that generic drugs may be unsafe are completely groundless and based on anecdotal information, not good science. Politics and money, however, have trumped common sense even for many physicians on this topic.

My intent was not to offend anyone, only to educate. Take this information like you should take anything you read on the internet, with a good dose of skepticim.  I'm happy to personally communicate with anyone and provide you with information from the medical literature and the FDA that makes my point here.

Thanks

 

 

Re: Lamictal - switch to generic lamotrigine?

Submitted by PaulF on Sun, 2009-04-19 - 14:31

I appreciate hearing of Marley's story, as I was switched from Lamictal to Lamotrigine this past August, 2008, without my prior consent. Nineteen days later I experienced two complex partial seizures within 12 hours of one another, something that had not happened since prior to my June, 2006 right temporal lobe resection. Fortunately, I was not driving at the time. However, I had just reached my six-month seizure-free mark and had asked my physician to complete the statement of examination form required for me to have my license suspension lifted.

In a little over two weeks, I will be addressing members of the Michigan senate and legislature about my experience being switched from name-brand to generic without proper notification as required by Michigan law. I would appreciate hearing from other individuals who, like Marley, experienced life-threatening situations after being switched from Lamictal to Lamotrigine.

Feel free to share your experience by responding to this post or by emailing me directly at fishback.paul@gmail.com .

 

 

 

 

 

"I live in this onl and abundant moment." --John Otterbacher, from his book "Sailing Grace"

I appreciate hearing of Marley's story, as I was switched from Lamictal to Lamotrigine this past August, 2008, without my prior consent. Nineteen days later I experienced two complex partial seizures within 12 hours of one another, something that had not happened since prior to my June, 2006 right temporal lobe resection. Fortunately, I was not driving at the time. However, I had just reached my six-month seizure-free mark and had asked my physician to complete the statement of examination form required for me to have my license suspension lifted.

In a little over two weeks, I will be addressing members of the Michigan senate and legislature about my experience being switched from name-brand to generic without proper notification as required by Michigan law. I would appreciate hearing from other individuals who, like Marley, experienced life-threatening situations after being switched from Lamictal to Lamotrigine.

Feel free to share your experience by responding to this post or by emailing me directly at fishback.paul@gmail.com .

 

 

 

 

 

"I live in this onl and abundant moment." --John Otterbacher, from his book "Sailing Grace"

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