Lamictal and It's Generic Lamotrigine
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Q:  Lamictal and It's Generic Lamotrigine

Hi, Dr. Phelps,
 The question first:  On the medications page of your website you mention that Lamictal is going generic, and that "prices will fall by mid-2009."  Do you mean that the brand name Lamictal price will fall in 2009?  Right now a 90-day refill of brand-name Lamictal by mail from Medco is $450.  I'm looking into the Canada option, which would be cheaper if my insurance would pay their share.  But if the brand-name price will go down in 2009 I might just suffer for a little while.
 In case you want to hear my story, I'm extremely scared of switching to the generic lamotrigine.  I had a horrible, scary relapse into ugly mixed-state hypomania in October when I started taking the Teva generic version of Wellbutrin XL. Fortunately within a few days I realized that suicidality wasn't normal and got my doc to call in a DAW scrip to the pharmacy.  I'd taken the Anchen generic for a few months before that with no noticeable problems, but now I'm scared to take generics on any of my psychiatric meds. 
 By the way, a search of PubMed turned up a bunch of articles, mostly from Canada, not only showing that epileptic patients had problems when switched to generic lamotrigine but that medical costs per patient went up despite the reduced medication price.  Here's one:  Curr Med Res Opin. 2008 Apr;24(4):1069-81. Epub 2008 Feb 29; the URL would take half a page.  I haven't found any studies on the same scenario with BP patients, though I easily found individual posts on BP boards describing what you would expect if a generic didn't work.  
 Enough late-night chattiness.  I've just re-read your sleep-cycle article and am going to bed.  Thanks as always for your fantastic work.

Dear Lenore –

[Written 11/1/08; if you’re reading this more than a month or two after that, there may be new information. A version of the reply below has been posted on my website and will be kept up to date.  So for 2009 or later, go there rather than here.  But for November, here we go…]

Well, that was interesting.  Your question prompted a search for more information on this issue.  So far, I've simply been switching my patients over when no other medications are changing, so that we can see if just the switch to generic, that change alone, is associated with any worsening. (Granted, in people's real lives, other things which could influence relapse rates are always changing, so this is not perfect science here).  I have not had any problems so far, but as of October 2008 that amounts to about 20 patients.  I have also been starting patients on generic lamotrigine from scratch, and so far have not been struck that it wasn't working when I thought it should (as one might expect if the generic was not as effective as the trade name version).

A series of articles have been published on this issue now.   All this occurs against a background of concern, amongst both patients and doctors, that generics will not be as effective as the original trade-name medicationHaskins (no one seems to expect that the generic will be more effective).  In other words, there is an expectation that the generic won’t work. That means suggestive cases -- e.g. when seizures occur after a switch to generic -- are more likely to be remembered and reported than cases in which the generic worked as well as the trade-name version. 

One of the first major articles on this issue may include such a bias.Makus  The authors conducted a survey looking for doctors who’d had patients do poorly on generic lamotrigine.  Five percent of the doctors who responded (which was only 24% of those who received the survey) reported problems with the generic. In other words, 95% of those who responded had not seen a problem.  Overall, have of 544 doctors to whom the survey was sent, 6 physicians provided data on 8 patients who experienced adverse reactions on a brand-to-generic switch. However, interestingly, seizure control was regained in all but 1 case on a switch back to the branded drug.

One of the ways investigators have tried to compensate for observation bias is to compare rates of return to trade name switching amongst different medications. Another Canadian teamAndermann found that switch-back-to-generic rates were 20% for clobazam (akin to clonazepam/Klonopin); 20% for valproate/Depakene (which is akin but not identical to the divalproex/Depakote pair); and 13% for lamotrigine/lithium.  By contrast, another study found higher rates of switch back overall: 28% for lamotrigine, versus between 21% to 44% for other anti-seizure medications.LeLorier.1  One could interpret these data as suggesting that lamotrigine is no worse than other medications in terms of the generic working less well than the trade name version.  If anything, it might be a little better than average.

 However, another way to avoid observational bias would simply be to look at actual blood levels of medications before and after a switch to generic. Such a study was just published two months ago (August 2008), and indeed showed that in 21 out of 26 cases, blood levels were lower on the generic compound.Berg

Finally, after all that we come to the article you referenced.LeLorier.2  This is one of several articles published by this team, using the same statistical method.  Their focus in this article on the health care system costs of switching to generic. Interestingly, by their analysis, the money saved on generic lamotrigine was eclipsed in the slightly increased cost of care.

How to interpret all this?  Here's mine.  Whereas neurologists use lamotrigine to control seizures, psychiatrists use it to control mood stability.  For mood, lamotrigine seems to exhibit a "dose -response relationship": in other words, the higher the dose, the better the symptom control.  Whereas the difference between 50 mg and 200 can be substantial, the difference between 250 mg and 300 is often quite subtle.  So if there really is a lower blood level with the generic, and the consequences in terms of symptom control may not be very profound -- in psychiatry.  In  neurology, that could be quite different, because a slight difference in blood level could mean the difference between having no seizures, and having one -- and a single seizure can have terrible consequences. In other words, control of epilepsy may be much more sensitive to the absolute club level than control of mood symptoms.  That's good news for psychiatry.  Mind you, this is my speculation.

Moreover, if a patient has started on a generic from the beginning, and gets good symptom control, the whole issue is moot.  So it won't be long, if the generic continues to work as well as it has so far for me, before this whole issue is less concerning.  Nevertheless, based on the 2008 article by Berg and colleagues, I’ll be figuring that my patient might be losing a bit of her prior blood level when switching to generic lamotrigine. Occasionally that might even mean I will move the dose up a little when I switch, although I have not done that yet.

Thanks for your question.  That was an important bit of study.

Dr. Phelps

Published November, 2008

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