The US Food and Drug Administration has issued an alert about Lamictal (lamotrigine) that suggests that babies exposed to the drug during the first trimester in pregnancy may have a higher chance of being born with a cleft lift or cleft palate. Additional research is needed to establish further evidence of this observation and this alert was issued from FDA’s preliminary data analysis for Lamictal. FDA will update its alert as further information becomes available. Lamictal is manufactured and marketed by GlaxoSmithKline and is approved for the maintenance treatment of delaying future mood episodes in patients with bipolar disorder type I. Lamictal is also approved as adjunctive (add-on) therapy for patients with seizure disorders.
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I am currently 7 weeks pregnant and have been taking Lamictal for the past three weeks. I am very concerned about the possibility of my baby being born with birth defects. My doctor put me on this medicine due to his diagnosis of possible bi polar disorder and complex post traumatic stress syndrome. I was also on several anti depressant medicines that did not work for me at all.
I agreed to take this medicine because he put me on a gradual doses. The first two weeks I was on 25 milligrams and for the next two weeks I’m on 50 milligrams and after that 100 milligrams and so on until I’m on 200 milligrams. Does the fact that I’m doing it gradually reduce the risk of birth defects, or if I feel this concerned should I just refrain from taking it until after my first trimester?
The only thing my doctor said was that there is no real medicine that is safe to take while I’m pregnant. He is concerned for my safety because I have extreme mood swings and get severely depressed. I have been feeling dizzy, short term memory loss, difficulty concentrating, short of breath, and very tired but it’s hard to tell weather these symptoms are caused by my pregnancy or the medicine.
Your feedback would be greatly appreciated.
Hi Glenda:
Your doctor is right – there is no “safe” medicine to take while pregnant. All antidepressants and psychotropic medications I’m aware of are at “pregnancy category C”, which according to the FDA means “Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.”
I looked up the prescribing information (PI) for Lamictal, which states the following:
You are currently on less than half of the actual highest human dose recommended (500 mg). Granted, the above pregnancy data is in animals and not in humans, and data on the effect of Lamictal on pregnant women may only be available from the company. You may either call the company’s medical information and inquire about availability of this information, or ask your doctor to translate some of the above information from animal data if you want to find out more.
Best wishes,
Jane Chin
Hi, When I read “highest human dose recommended (500 mg).” in the answer above, I get really worried. I now take 500 mg due to epilepsy, and my doctor said that if I will need to increase my dose in the future, 800 mg is the highest dose I can take of Lamictal. I am thinking of getting pregnant, but I guess that it is out of the question if I don’t decrease the dose?
Eva, if you are planning on becoming pregnant in the near future this is a crucial conversation you need to have with your physician.
I am now 12 weeks pregnant. I took Lamictal for the first five when I didn’t know I was pregnant. I was only on 150 milligrams and was on it for three years. I stopped immediately upon learning I was pregnant. Is there a possible chance that my baby could still be at risk or would immediately stopping lessen that risk?
Hello dee!
How are you? I just read your post and I see you are/were in the same exact position I am currently in (you are just farther along in your pregnancy). Will you be having all the fetal testing done and/or amnio? I am very scared? Thanks for your time! Hope to hear from you soon!
Hi there, I am 6 weeks pregnant and was on 250mg per day when I found out, I decreased to 225 for a week and then I’ve started on 200, seeing my psychiatrist 15th feb for advise, but my doctor said to take over 10 x the recommended daily does of folic acid due to the medication and this can really help reduce risks in the first trimester. So yes, 5g of folic acid required…..you can get these large ones on prescription here in England, usually one is advised to take 400mg per day.
I am not too worried, not as much as I was in the begining, after all the research I have done filtering through information to get a reliable picture, I can see that the risk of birth defects is very low, almost the same as someone who is not on medications. The things that concerns me the most though is behavioural effects on the child, as the drug hasn’t been around long enough to study this side of things as well. (my opinion).
One can’t help but be a bit concerned though so it will be good to be in touch with people who are going through the same worries…. *sticky vibes*
sorry I meant 5mg (12 400mcg tablets)….of folic acid, not 5g, I got confused by mcg’s and mg’s
Dee, Brooke, and Amie,
I just stumbled upon this website and saw that the three of you are concerned about taking Lamictal while you are pregnant. I wanted to tell all three of you that I have 2 beautiful, very healthy, very bright girls and was taking a large amount of Lamictal while I was pregnant with both of them. As a matter of fact with my younger daughter I was taking 1300 mg/daily by the time she was born. When I was initially pregnant I was on 750 mg/daily and as I grew with the pregnancy my levels and seizure activity dictated that I increase all the way up to 1300 mg. My children are both very healthy. I would encourage you to continue your medication while the doctor says that it is safe. In my case, seizure activity would have caused more problems with the pregnancy than the Lamictal itself. I do want to assure you that my babies (now 3 and 7) are wonderful and with the right pre-natal care yours will be too!! Good luck to all of you!
I take 300mg of Lamictal right now, and my husband and I will TTC this month. My OB said that it is ‘ok’ to take it during pregnancy since i’m a ‘rapid cycler’.
For anyone that has posted, is your baby monitored more? When can you find out about a cleft lip? I’ve heard that is the most common birth defect.