Comments on: Generic Lamictal (lamotrigine) for bipolar disorder

By: Neil Stegall

Neil Stegall — Fri, 13 Nov 2009 17:53:59 +0000

Over 14 patients in our mental health practice have developed irritability, depression and mood instability after being forced by insurance to switch the generic lamotrogine. Contrary to what some think, generics are different in terms of bioavailability- absorption- and bioequivalence. The dose is required to be only 80-quite low- to 125% of the plasma concentration of brand name drugs, which must consistently be within the 5% range. There are no clinical studies or random controlled trials for any generics. They can be dangerous. I am working with a lawyer to see if a case can be developed against insurance, pharmaceutical management and pharmacy companies as this constitutes the practice of medicine- making a clinical decision without prescriptive authority, etc. Post if you are interested in considering participation in a possible class action suit. This is for all people on maintenance medication, not simply Lamictal. BTW seizure patients are having difficulty- sometimes life threatening- as well re: generic lamotrogine.

By: Admin

Admin — Sun, 18 Oct 2009 00:32:30 +0000

Hi Susan,

I am SO VERY HAPPY you saw this post. I literally got better in a few days when I went back to my brand Lamictal. I had to call my insurance and explain what happened. My doctors were also willing to support my need for Lamictal. I now have to pay a $70 copay instead of $5, but it’s better than being sick. Good luck- I suggest that you go to the right of the blog and read the entries under Lamictal- there are many that truly explain generics and how the information we receive is often skewed to generic use as it’s less expensive for insurance companies. Please know that I am NOT against generic medications- I know many who take them with no problem- but I do feel that we don’t receive the information needed when we are switched without a list of warning signs the drugs aren’t working. Please keep me posted on this. I hope that you get relief ASAP. Hang in there! Things can get better! Julie

By: susan

susan — Sat, 17 Oct 2009 23:43:40 +0000

I notice that the date for this was months ago. I am glad I saw this. I thought I was losing it. I am on the max of 300, and have been for over 3 yrs now. I am a single mom with gov insurance. I went back to school and have been doing great, just had midterms and bombed them… They switched me last month, and it is the teva… I don’t care about anything right now
Anyways… thanks for the post- I plan to call my doc on Monday

By: Aisha

Aisha — Tue, 07 Jul 2009 03:27:35 +0000

Hi, Julie -
I sure wish I’d seen your newsletter before I let my doctor switch me to lamotrigine. I don’t know if what I’ve been taking is made by Teva, but it’s been awful, just like what you experienced. When I called my doctor for an “emergency” appt last week, and described what had been getting progressively worse over the past month,he clearly didn’t credit the generic with the profoundly negative changes I’ve been having, saying these types of responses to generic Lamictal are “very rare.” That’s not what my research (including your newsletter) shows, though. I managed to get him to give me a script for Lamictal, and I hope it doesn’t take long to kick in. How long was it for you? I’m just relieved that, once again, it’s NOT ME, but the bipolar. I wholeheartedly agree with what Lindsay wrote in February. The following blog entry gave addresses and phone numbers to report experiences with the FDA: “Did you know that you can report these problems (called “adverse events”) directly to the FDA? Go to “http://www.fda.gov/medwatch/” ;

Ask your doctor to report this. If he/she is reluctant to do it then you can report it yourself. Reports can be made by healthcare providers or by consumers (patients). You can submit a written form or online form.

The written form is at:
http://www.fda.gov/medwatch/safety/FDA-3500_f...

The online form is at:
https://www.accessdata.fda.gov/scripts/medwat...

They say it’s for serious adverse events including “therapy inequivalence/failure”. I’d say that’s exactly the problem with the generic forms of this medication. The doses are not “equivalent” to the brand-name.

Generics are legally required to be equivalent to the brand-name in both the active ingredient and the dosage. There is an acceptable range (in other words – no pill is going to be 100.00% accurate), but from the symptoms people are reporting it sounds like a lot of the time the generics are not within the acceptable range. Or else the FDA’s range needs to be re-set so people aren’t having these problems.

Several different companies make the generics, so be sure to report the name of the generic company (if that’s listed on your bottle) or copy down all the numbers and/or letters on both sides of the pill, give the shape and color of the pill, etc. That way maybe the report will be linked to the company who actually made the pill. By the way, here’s the FDA’s phone number if you have questions: 1-888-INFO-FDA (1-888-463-6332)”

Hello Aisha,

WOw, this is great information. I am going to put it on a regular blog tomorrow. I just wrote an article for a NAMI newsletter on this topic. It’s very clear that the NEW generics can be very dangerous- if I didn’t have my treatment plan- I would have gone to the hospital- it was that bad! I was immediately better when I got back on the brand Lamictal. It only took a few days for me to at least start feeling like myself again- the terrible twitching went away within a few days.

But, as I say in my blogs- others have taken the generics without problem- but we do need to be super careful- The generic lamotrigine is a reality that won’t go away- the insurance companies will make sure of that. What matters is that the FDA gets it regulated. There needs to be a list of facilities that are putting out the bad generics! I am going to pass on your information to everyone I can. I will send it to my mailing list, etc. You have helped a lot of people. Julie

By: Lindsay

Lindsay — Sat, 21 Feb 2009 04:22:44 +0000

I had the SAME experience and am extremely angry about the lost time and depression I suffered because of generic Lamictal. I started taking Lamictal last January and switched to the generic last August. I didn’t know that the medications could act on my system differently, and by the time I figured it out, I had lost five months of my life racking my brain for answers as to why I was so depressed. I hope people are aware of this and be extremely vigilant about getting the medications that they need.

By: Rachel

Rachel — Fri, 20 Feb 2009 23:08:16 +0000

I was prescribed generic Lamictal 9 days ago and started to not be able to function 3 days ago. I had headaches, nausea, and labile mood swings. Thank you for your post because it confirmed what I already thought, which was that the generic Lamictal was not working for me. After going to see my Dr. today that suspicion was confirmed. The manufacturur that is, at this time, making generic Lamictal has been making a lot that people have been reacting to. They are allowed to only have a certain percentage of active drug ingredients in their formula. Anyway, I hope that people with reactions to the generic will read this site. It came up for me when I googled “generic lamictal” and I’m really grateful! Thanks!

Hi Rachel,

wow, there are SO many different sides to this story. I have heard from people throughout the industry and most say that the formula has to be the same, and yet too many of us are having trouble! I can’t seem to get an exact answer as to why this is happening- but it’s happening. I will keep getting more info and put it on the blog! Thank you for your story and I’m glad you found an answer! Julie