The following comment was received in response to one of my previous posts: “My friend has just discovered she was pregnant...at her yearly exam. The problem is she takes several meds…Adderall…(and) Cymbalta. She is around 13 weeks and is stressing due to meds. She has not had a complete ultrasound yet. What are her options? This child could have some serious issues correct?”
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…