More on Meds and Pregnancy: Adderall and Cymbalta
Saturday, January 27, 2007
Kenneth F. Trofatter, Jr., MD, PhD
More and more women in the childbearing years are on combination drug therapies, often antidepressants and antianxiety agents, and sometimes additional medications to treat the side-effects of these other drugs. The questions above arise on a daily basis in my practice and the simple answer is “I don’t have an easy answer.” Adderall is an amphetamine (stimulant) that is used to treat ‘attention deficit hyperactivity disorders (ADHD)’ and ‘narcolepsy,’ a condition associated with frequently and uncontrollably falling asleep. Cymbalta is a drug that is used to treat major depressions and is classified as both a selective serotonin reuptake inhibitor (an SSRI, like paroxetine) and as a selective norepinephrine reuptake inhibitor (SNRI).
The dilemma I face when counseling patients in this situation is the following: BOTH are classified as FDA pregnancy category C drugs. This means that at sufficiently high doses (many times the highest recommended doses in humans), teratogenicity (birth defects) and/or embryotoxicity (fetal death) were demonstrated in certain (not necessarily all) animal experiments. Although the safety, effcicacy, and typical side-effects in nonpregnant humans have been defined in clinical trials before the drugs were marketed, as with most drugs, no controlled or even observational studies have been done (and probably never will be) in pregnant women with either of these drugs to look for deleterious effects similar to those found in the animal studies. Furthermore, even if each of these drugs turns out to be relatively safe by itself, the COMBINED effects are completely unknown. Herein lays my daily dilemma. Remember, as pointed out in my previous posts, it took years of human use before the problems associated with valproic acid and paroxetine were suggested by outcomes collected in voluntary pregnancy registries which are not the most efficient or scientifically rigorous means of gathering good data.
So, let’s get back to the patient query above. By 13 weeks, the baby has completed the embryonic period and almost all organ systems have formed their basic anatomic structures. If these drugs cause malformations of the heart, spine, kidneys, gastrointestinal tract, face, etc…there is nothing that can be done to prevent them at this point. In view of the patient’s concerns, I suggest counseling with a geneticist and a specialist in maternal-fetal medicine. Some fetal abnormalities can be seen by ultrasound even this early in the pregnancy. In addition, I would strongly recommend maternal serum screening at 16 weeks’ followed by a ‘targeted’ (sometimes referred to as a ‘level 2’) ultrasound at 18-20 weeks.’ If fetal malformations are identified during the pregnancy, or following delivery, these should be formally reported to the companies that distribute the drugs.
Even if no major fetal malformations are found, both of these drugs are in classes that are known to have potentially deleterious effects on the pregnancy and perhaps on both short- and long-term development of the baby's brain and nervous system. Whenever these circumstances arise, it is strongly suggested that the prescribing physician evaluate the need for continuing the drugs, the possibility of reducing doses to the least necessary to control the condition during the pregnancy, or perhaps suggesting alternative medications that may have a safer ‘track record’ during pregnancy. There are always risks and benefits that have to be weighed with regard to continuing and discontinuing therapy and these require individualization that cannot be addressed in the ‘blogosphere.’ Ideally, this discussion between patient and provider should be held preconceptionally, but even now, with regard to the inquiry above, this is definitely worth pursuing. And, to offer some reassurance, despite the unknowns and the general tone of my comments, the overwhelming odds are that the baby will suffer no serious consequences of this maternal medication use.
In my next post, I will discuss some of my pregnancy concerns related to both Adderall and, as promised previously, the SSRI class of drugs. Until then, see y’all…
5 Comments:
At Sun Jul 27, 10:32:00 PM 2008,
Danielle M said…
Hi. I am interested in finding out all information that you may have in regards to Adderall or Add. XR & pregnancy..... I understand due to research there are many questions that are going to go unanswered, however it would be nice to know trimester wise how these drugs could pose problems and what too. - etc.
I am a 31 female with my third pregnancy and have been taking Adderall XR most of my pregnancy. Out of seven days in a week on average I do take it 4 to 5.
Thank you in advance for any advice you may give me.
At Sat Aug 16, 03:33:00 PM 2008,
Kenneth F. Trofatter, Jr., MD, PhD said…
Danielle: I am sorry it has taken me so long to get back to you, but I just found your query. In all honesty, I don't think we know enough about Adderall to say anything about its long-term safety for babies when taken during pregnancy. It is a FDA Category C drug which means it has beeen shown to have deleterious effects on animal fetuses during implantation and pregnancy, but these studies are always done at much higher doses than are used in humans. I do have concerns because the drug is a mixture of amphetamines and there is certainly the potential for fetal 'addiction' and abnormal 'wiring' of the brain as the result of chronic exposure early and throughout gestation. Unfortunately, it will be many years of monitoring known exposures in people like you before we have the final answers. Best wishes and thanks for writing. Dr T
At Wed Nov 05, 06:41:00 PM 2008,
Anonymous said…
Hi, I have a follow up to this question. I am 28 and planning to start trying conceive with my husband next month. I have taken all the vitamins for several months DHA and Folic acid. I've done everything by the book and thought I perfectly prepared. I then spoke to my doctor about our plan and she informed me that i needed to stop taking Adderall before we even conceive. I work in finance in a high pressure, fast paced environment. I've accepted the fact that I will have to stop it once i do get pregnant but the thought of having to go med-free while we're just trying is really overwhelming. It takes an average of 6 months to conceive so I'm having a hard time accepting this situation. I've read in all my books that nothing is really exchanged with the mother and the fetus until 5 weeks. I have monitored my cycles I would test early and often. Do you think there is a high risk of having complications if I am only taking Adderral during the first two weeks or less post conception?
Thank you for this blog. I have been researching for weeks now and just came across your blog. There is limited information out there on this topic so it is much appreciated!
Kind Regards,
Kate
At Fri Dec 12, 10:31:00 AM 2008,
sunny_wells said…
Hi - I am a 36 year old mom of 4 children and currently pregnant with my 5th. My two older children were diagnosed with ADHD about 7 years ago and I followed with my own testing and diagnosis. I have been on Adderall XR ever since. I generally take 30mg./ day. My last pregnancy, which began in December of 2006, I was also concerned about my Adderall intake. My doctor gave me the same song and dance that I find everywhere on the web "it's an FDA category C drug; if the benefits outweigh the risks, then keep taking it. If not, then don't". Well.... this didn't answer my question. I decided during the first trimester to decrease my dosage to 10mg./ day. towards the end of my 1st trimester, I went up to 15mg. and during my last, I went up to 20mg. My baby was born very healthy with no weight issues whatsoever. He was born premature, but this had nothing to do with the adderall. He had the cord around his neck 3 times and I was experiencing decreased fetal movement; they did an emergency c-section at 32 weeks. Even at that early delivery, he was almost 5 lbs and only had to stay in the hospital 2 weeks. He is now an active, incredibly smart and intelligent 16 month old. Needless to say, I'm very happy with the outcome. I'm currently pregnant again and I've decided to follow the same regimen and I'm sure I'll get the same outcome. But I'll keep you all posted. Being a high risk pregnancy, they tend to follow me pretty closely anyway, so if we start to see anything, then atleast we'll know early.
At Tue Mar 17, 11:03:00 PM 2009,
Anonymous said…
Hello - I'm 32 & have been on ADD meds since I was 18. I'm currently taking Adderall XR. I know it's Category C, so I would try to go off of it while trying to get pregnant. But, I've gotten different feedback from MDs about how far in advance I'd need to be off to have it out of my system. How long does it stay in your system? I've heard I should stop 3 months ahead, and then another MD said I could just stop when I get pregnant. What are the deciding factors? I take 20mg/day and weigh 130. Also, another MD suggested switching to something that has a shorter lifespan, like Ritalin. Would switching to something that is not an extended release med make a difference? I have a high pressure job and of course a pregnancy would come first, but I also need to keep my job! I'm looking for any info I can find on when to stop taking it, and whether anything else could be used before I'm actually pregnant that would not put the baby at risk. Thanks in advance for any info you can provide.
-Sara
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