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Dr. Goldberg : Abilify and Pregnancy
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An_189166 posted:
Just diagnosed with BPII and prescribed Abilify 5 mg daily. I told my doctor that we are trying to conceive and he said Abilify is safe in pregnancy. I have not read anything on the internet that supports my doctor's comment. Everything I have read is either inconclusive or says you should stop taking Abilify if pregnant or breasfeeding. What should I do ??????
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Joseph F Goldberg, MD responded:
Dear Anon,
Most psychiatric drugs have no known risks in pregnancy -- that is, FDA "category C." A few exceptions are Depakote and Tegretol (both Category D -- known to cause defects in the developing nervous system), and lithium has a low but
possible risk of a specific heart malformation called Ebstein's Anomaly (about 1/2000). Paxil, also, has a known risk for causing pulmonary hypertension and heart valve defects.

That said, some category C medicines have been around much longer than others and are simply better studied, so that even though there are no known risks, we tend to favor those that have more years of experience and known exposures to better reduce the uncertainty. If someone is already on a particular category C drug and is stable, there's little justification in chagning to a different drug of unknown risk just for the sake of picking something that's better studied (and now exposing someone to multiple unknowns)...but, if one has the opportunity to pick something from the start before pregnancy begins, it makes sense to choose the best-studied drugs in pregnancy. We try to minimize the number of exposures to different drugs in pregnancy for obvious reasons (additive unknowns increase the number of unknowns...)

Abilify, like all atypical antipsychotic drugs, is a category C drug that has no known risks...but that doesn't mean it is known to be safe and has NO risks....it has no KNOWN risks. Doctor and patient need to have a frank conversation about the known and unknown risks of all available relevant drugs and then together decide what's the most reasonable course of action. It is not correct to say Abilify has no risk. It has no KNOWN risk.

Among atypical antipsychotics, Zyprexa and Seroquel both have more extensive published studies of use in pregnancy from what's called post-marketing surveillance than does Abilify (the newest kid on the block, with the least experience)...but, Zyprexa and Seroquel also may be more prone to cause weight gain or changes in blood sugar and lipids...so there is no simple answer. There needs to be a careful discussion of the risks and benefits and what might be called an informed "shared risk" by doctor and patient.

- Dr. G.
 
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Joseph F Goldberg, MD responded:
Also....for what it's worth....Abilify has never been studied in bipolar II disorder so it may be worth asking your doctor to explain more clearly the basis for picking that drug over ones that have been studied for bipolar II disorder, and what exactly it is he or she is trying to treat. If it's depression, Abilify has been shown in 2 controlled studies not to treat bipolar depression. If hypomania, it's probably OK, but a "big gun" drug for hypomania. Have the doctor go through all the options for your specific condition so you can together make the best decision for what will work (and not likely need additional medicines added) given the unknown risks.
- Dr. G.
 
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Tristesa replied to Joseph F Goldberg, MD's response:
He did prescibe abilify for hypomania. I spend most of my time in a hypomanic state. Only bouts of depression once or twice a year for about a week or so. I am very functional, very good career. I never miss work. I also appear to be a perfect housewife. I have so much energy, I am always cleaning and cooking. Abilify seems to be working for me, although I was having some pretty nasty side effects on the 5 mg. I cut the tabs in half and am having no probs. I do not want to take any meds when I get pregnant. I seemed to have gotton better during my first pregnancy and stayed well mentally for 8 to 9 months after the birth of our daughter! Is that possible?
 
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Joseph F Goldberg, MD replied to Tristesa's response:
Yes, certainly. The concern would be if a relapse were to occur. This is why medication decisions during pregnancy must be made on a case-by-case basis. If someone has had hypomanias but not manias and no recent depression, and is stable, then it may be quite reasonable to try to get through at least a first trimester (when the major organs are forming) with no medicines unless necessary. On the other hand, someone who is not clinically stable and has had significant mood episodes may be a poorer candidate for trying the med-free route while pregnant. If I had a patient doing well on Abilify I would probably favor continuing it as the drug of choice in a pregnancy rather than experiment for new medications (which may or may not work as well), though if I were choosing medicines before pregnancy occurred I would likely favor something that's been better studied in pregnancy than Abilify (eg, Seroquel, Zyprexa, Haldol).
- Dr. G.
 
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anon937 replied to Joseph F Goldberg, MD's response:
I am nullipara, dx'd BPI at age 12, inattentive adhd in my 20's, stable on 30mg of Abilify, 300a.m./400p.m mg Tegretol, 10mg Lexapro, 10mcg Cytomel, 100mcg Synthroid, 70mg Vyvanse, 50mg Seroquel.

During a previous pregnancy, I suffered what seemed to me more "cervical cramping;" lower and more centered than my regular menstrual cramping. That pregnancy terminated at about 6 weeks due to voluntary medical abortion.

I'm concerned @ switching to less teratogenic meds and remaining stable during a planned pregnancy.


I understand Tegretol is D, and I believe the majority of the rest are C.

I have never been more stable than in I have in the past year, due largely do the addition of the Abilify (i was improved, yet still depressed/agitated on the previous atypical, Geodon. Once I reached 30mg Abilify, I felt it worked miraculously well for the irritability/depression), then Cytomel, then Vyvanse, and a taper down from 900mg Seroquel p.m. to 50mg. And, of course, abstinence.

I am an ultra-rapid cycler; I recall a specific incidence, when hospitalized immediately upon voluntary cessation of a cocaine binge, I hit at least two manic and two depressed states w/in one day. History of benzodiazepine and alcohol dependence. During periods of sobriety I have had massive shifts in mood w/in the same day, though I have learned more positive coping and stress reduction skills

I have been drug, alcohol abstinent for nearly a year, and was considering a pregnancy w/in the next three years.

I have also recently come across the term "squalae," as in, psychotropic drug use during pregnancy may result in squala or squalae, perhaps not noticeable for years and not necessarily anatomical, but physiological, such as behavioral or cognitive due to pharmacological insult. Are there any statistics about this for the different classes of drugs I take?

Am I a potential candidate for a safe pregnancy due to my lability prior to, particularly, the addition of Abilify, which I understand may cause "slowness"?

My main concern is the possibility of any type of fetal insult resulting in cognitive/behavioral dysfunction. I am more than willing to participate in a therapeutic abortion due to anatomical defect.

Of course, remaining stable is a priority as well.

In short, do I have a hope of nonteratogenic pregnancy and stability, or would I be better suited to pursue another avenue toward becoming a parent?
 
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Joseph F Goldberg, MD replied to anon937's response:
Dear Anon,

Tegretol has a 1-5% risk of neural tube defects, which can cause spina bifida, an abnormality in the developing central nervous system. The risk is relevant only in the 1st trimester (actually, probably really just the first 4 weeks after conception, since that's when the nervous system forms). Tegretol is not an absolute no-no in pregnancy but it is much preferable not to take it if possible. Spina bifida can be detected by a blood test as well as ultrasound by week 16, if need be.

There is no clear evidence that any of the other medicines you are taking pose any known risk for birth defects to a developing fetus (but there are always possible unknown risks). It becomes a deliberation and discussion to have with your psychiatrist as to whether the known risks of the illness (ie, relapse, and psychiatric instability during a pregnancy) outweigh the unknown (if any) teratogenic risks of conttinuing medicines that are helping you.

"Sequelae" is a general word that refers to lingering problems of any kind -- eg, the sequelae of depression may be a negative attitude; the sequelae of bronchitis may be a dry cough; the sequelae of a sports injuryt may be a sore leg; etc. I suspect if you've come across the language that medications might have "sequelae" in an unborn fetus or post-partum, it is CYA-speak for "there might always be some presently unknown problems that a drug could cause which years later could make themselves manifest." This is all conjecture.

Many women who are on stable medication regimens for bipolar disorder, taking Category C medicines, do just fine in pregnancy and have healthy babies and healthy themselves.

- Dr. G.
 
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jerairo replied to Joseph F Goldberg, MD's response:
Dr. Goldberg,

In regards to your statement, "Many women who are on stable medication regimens for bipolar disorder, taking Category C medicines, do just fine in pregnancy and have healthy babies and healthy themselves."


Have you worked with women that want to get pregnant on Abilify, and what has been the prognosis? Where the babies healthy? How many miligrams were these patients on?


Thank you,
jerairo



 
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Joseph F Goldberg, MD replied to jerairo's response:
Dear Jerairo,

I have worked with many patients who have wanted to get pregnant, and gotten pregnant, and gone through uneventful pregnancies while taking Category C drugs, where both the patients and I mutually understand there exist unknown risks. I don't believe any of these patients was specifically taking Abilify. I probably use Abilify less often than other atypical antipsychotics because of the negative data for bipolar depression as well as the akathisia.

I'm not aware of any unhealthy babies among my own patients, but generally speaking one has to remember that minor malformations can occur irrespective of taking medications, and also, untreated depression itself can be teratogenic, so it's hard to make any generalizable conclusions about medication effects in pregnancy, either good or bad, from the experience of just one practitioner. .

- Dr. G.
 
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jerairo replied to jerairo's response:
Dr. G,

Thank you for your prompt response.

My wife is bipolar. 5 years ago, the doctor had prescibed lithium 900mg per day. She was stable. We then decided to try for a baby, so the doctor weaned her off the lithium, and she became pregnant. Everything went well for the entire pregnancy, and no medication was needed. We have a healthy child, thank goodness. After delivery, she began to have a manic episode so she was prescribed 5 mg abilify per day. She was stable for 3 years. We then decided to try for another child, so the doctor gradually weaned her off. She was stable for only 45 days with out medication. Before she was able to conceive, she had a manic episode and was hospitalized. The doctor immediately gave her ativan and haldol to sleep, and started her back up on Abilify. Now the doctor says she shouldn't get off the abilify and that maybe we should start for a baby while on medication. Why would there be a relapse in just 45 days? If she were to conceive and then had an episode, then is it worse to remain in a manic state or go with haldol, ativan, and abilify? Thanks much!
 
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Joseph F Goldberg, MD replied to jerairo's response:
Dear Jerairo,

Relapses unfortunately can happen, with or without medication. It's not an easy or straightforward decision whether to try to conceive on medications, and if so, which ones. Some might argue that the main risk of lithium is a 1/2000 risk of a heart valve defect called Ebstein's Anomaly, but if lithium worked well, it may be worth resuming throughout a pregnancy. It is not an absolute no-no.

Abilify is more of an unknown; while there are no known risks, in the 10 or so years it's been out, there's always the possibility of the unknown....if she did well with Abilify, then the benefit of staying well may outweigh the risk of the unknown (or, no known risk). Generally, we try to minimize the number of medicines a woman takes in pregnancy to minimize the number of additive unknowns. So, often, the goal is to pick one medicine and try to stay with it and not switch around during pregnancy.

- Dr. G.
 
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jerairo replied to Joseph F Goldberg, MD's response:
Dr. G,

Which category C drug is the one you prescribe to women who want to conceive?

Are there any category B antipsychotic drugs for bipolar?

Do any of these drugs ever change categories, for example, moving from a category C to a B?

Thanks again, jerairo
 
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Joseph F Goldberg, MD replied to jerairo's response:
Dear Jerairo,

The decision of which medicines to prescribe for women who want to conceive really depends on a woman's personal history of response to a given agent. One is aiming to achieve and maintain a normal mood, so, whatever category C drug gets the job done is the most likely candidate for use in pregnancy. There are no category B antipsychotics except for, believe it or not, clozapine, which somehow got grandfathered in -- I can't imagine the FDA would give clozapine a category B status if it were being reviewed today, given its many known risks (diabetes, weight gain, agranulocytosis).

I don't believe the FDA has ever reclassified a D to a C or a C to a B in pregnancy.

- Dr. G.
 
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jerairo replied to Joseph F Goldberg, MD's response:
Dr G:

On average, how long does it take for a bipolar patient to be weaned off medication if they want to try to conceive?

For example, if a patient is on 7.5mg Abilify, does it take 3 months? 7.5 to 5.0 to 2.5 to 1.0mg?

Or is does the weaning period take about a year?

Thank you,

Jerairo
 
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Joseph F Goldberg, MD replied to jerairo's response:
Dear Jerariro,

The time it takes for a medication to leave one's system varies by medication. Abilify takes about 2 weeks for the blood level to become undetectable.

Obviously, though, many other factors go into the complex decision about whether or not to take someone who is stable off of a medication, how quickly they are likely to be able to conceive (eg, age, past fertility experiences), what the plan will be if they relapse off medications, etc. Close collaboration with an obstetrically knowledgeable psychiatrist and a psychiatrically knowledgeable OB-GYNE are a big plus.

- Dr. G.


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