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Maternal & Child Community

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medications during pregnancy

by andersonsara, Dec 28, 2003 12:00AM
My husband and I are ready to have another baby, but due to postpartum with my last child I am taking wellbutrin and lexapro.

My family doctor told me that the lexapro was safe during pregnancy but not wellbutrin. My gynocologist said that wellbutrin was safe but not lexapro. I am very comfortable in the fact that I need to take something but don't want to harm an unborn baby. Who is right and who should I listen to?
Member Comments (4)

by nurse12hr, Dec 28, 2003 12:00AM
I found some info on wellbutrin, which is a class B pregnancy drug, which means: "NO EVIDENCE OF RISK IN HUMANS. Adequate, well-controlled studies in pregnant women have not shown increased risk of fetal abnormalities despite adverse findings in animals, or, in the absence of adequate human studies, animal studies show no fetal risk. The chance of fetal harm is remote, but remains a possibility."



"A. While there is information to support the use of certain antidepressants, including fluoxetine, citalopram and the tricyclic antidepressants, during pregnancy, there are much less data on the reproductive safety of bupropion (Wellbutrin). Information from the manufacturer (GlaxoSmithKline) includes 166 pregnancy outcomes involving first trimester exposure to this medication. There were 133 live births without birth defects, 22 spontaneous abortions, 8 elective terminations, and 3 infants born with birth defects. This represents a 2.1% risk of congenital malformation, which is consistent with what is observed in women with no known exposure. This information is reassuring; however, further studies on the reproductive safety of this medication are warranted.



Despite the lack of data, there may be certain situations when it is appropriate to use this medication during pregnancy. If a woman has had a poor response to serotonin reuptake inhibitors in the past but has had a good response to bupropion, one may consider re-initiating treatment with bupropion. This is done, of course in the context of an informed conversation with the patient, acknowledging the lack of extensive information regarding its reproductive safety. It is important to remember that untreated depression in the mother is not benign and may place both the mother and her children at risk. With regard to optimal dosage during pregnancy, the lowest effective dosage should be used. The dosage of medication needed to keep her well before pregnancy should be maintained across pregnancy, unless she develops symptoms of depression when pregnant, at which time the dose could be raised to insure mood stability."



And this about Lexapro, which is a pregnancy class C drug, meaning RISK CANNOT BE RULED OUT. Adequate,well-controlled human studies are lacking, and animal studies have shown a risk to the fetus or are lacking as well. There is a chance of fetal harm if the drug is administered during pregnancy; but the potential benefits may outweigh the potential risks.



"There are no adequate and well-controlled studies in pregnant women; therefore, escitalopram should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.



Pregnancy-Nonteratogenic Effects



Neonates exposed to LEXAPRO and other SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These features are consistent with either a direct toxic effect of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome. It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome (see WARNINGS).



When treating a pregnant woman with LEXAPRO during the third trimester, the physician should carefully consider the potential risks and benefits of treatment (see DOSAGE AND ADMINISTRATION).



Labor and Delivery



The effect of LEXAPRO on labor and delivery in humans is unknown."

  



So, Wellbutrin is a pregnancy class B drug, and Lexapro is a class C drug.  I am not a pharmacist or an MD, but it would appear that there is more info and studies regarding the use of Wellbutrin than Lexapro.



Hope this helps.  Here is a link:



http://www.perinatology.com/exposures/druglist.htm







by lisantony, Dec 28, 2003 12:00AM
To: CHRISTIE
HI, WHAT DO YOU KNOW ABOUT PREGNANCY AND CLINDAMYCIN LOTION AND DIFFERIN CREAM , MY DERMATOLOGIST GAVE THESE TO ME AND I DID QUIT WHEN I WAS PG BUT AFTER THE D N C I STARTED UP AGAIN , I NEVER THOUGHT TO TELL THE DR I USED THEM FEW AND FAR BETWEEN, COULD THESE HAVE BEEN A CAUSE(MISCARRIAGE) DO YOU THINK? OR COULD THEY DO HARM NOW THAT IM TRYING AGAIN? YOUR A NURSE CORRECT I POSTED A ? TOO IF YOU WOULD HAVE ANY INSIGHT ON I WOULD APPRECIATE!! THANKS A BUNCH

LISA

by borg_aw, Jan 23, 2004 12:00AM
Unfortunately there is little actual information on Wellbutrin SR/Zyban (same drug)when it comes to pregnancy out on the

internet.  But there is some information available through the Freedom of Information Act as well as through GSK's Pregnancy

Registry (However, the registery is only sent to physicians and not to individuals.)



The following links contain information we have gathered from the FDA Medwatch as well as some of the clinical trials found in

the Zyban Summary Basis of Approval. (More to come in the coming months.) Animal studies were done at various dosing and

did show varying effects on the fetuses.  However, each is disregarded as exposure to maternal toxicity.  



In the MedWatch Report for Wellbutrin SR only (Nov 1, 1997- Feb 24, 2003), there are 163 reports of the mother's use of the

drug affected the fetus.  This figure as well as the total reports of fetal or congential defects equals 341.  However according to the GAO(Government Accounting Office), these figures only represent 1-10% of actual adverse reactions.



To view the information, go to:

http://geocities.com/borg_aw/articles/bupcongclintrial.htm

http://geocities.com/borg_aw/articles/fetuschildrensorted.htm





from http://www.perinatology.com/exposures/Drugs/Bupropion.htm

Bupropion (Wellbutrin ®, Zyban ®)

Antidepressant of the aminoketone class. Used in smoking cessation.

Molecular weight: 276.2

CATEGORY:B



"Reproduction studies have been performed in rabbits and rats at doses up to 15 to 45 times the human daily dose and have revealed no definitive evidence of impaired fertility or harm to the fetus due to bupropion. (In rabbits, a slightly increased incidence of fetal abnormalities was seen in 2 studies, but there was no increase in any specific abnormality)." [1]



As of February 2003, 764 pregnancies involving exposure to bupropion had been prospectively registered with The Glaxo

Wellcome Bupropion Pregnancy Registry.  As of June 2003, 154 pregnancies were pending delivery, 213 cases were lost to follow

up, and 397 cases with 401 outcomes were obtained.  The indications for use of bupropion in the latter were depression in 251 patients, smoking cessation in 95 patients, depression and

smoking cessation in 16 patients, bipolar affective disorder in one patient, and unspecified in 34 patients.



Of 322 outcomes involving bupropion exposure in the first trimester there were 261 live births without birth defects, 40

spontaneous pregnancy losses, 11 induced abortions, 1 induced abortion with evidence of Down syndrome on prenatal testing, and

9 infants born alive with birth defects.



The defects in infants born alive included one infant with  bilateral club feet, one infant with  Klinefelter's syndrome (no physical abnormalities), and  7 infants with heart defects (1 abnormal aortic valve thickening with mild aortic insufficiency,  1 ventricular septal defect, 1 trivial pulmonic stenosis with atrial septal defect, 1 coarctation with ventricular septal defect, 1 thickened heart muscle, 1 pulmonary stenosis, and 1 coarctation of the aorta).



The observed proportion of birth defects in pregnancies with prenatal exposure to bupropion in the first trimester was 3.7%.



Birth defects/disorders can happen with this medication as with any other medication or life situation. This information is not meant to scare, but to inform.



by borg_aw, Jan 23, 2004 12:00AM
Unfortunately there is little actual information on Wellbutrin SR/Zyban (same drug)when it comes to pregnancy out on the

internet.  But there is some information available through the Freedom of Information Act as well as through GSK's Pregnancy

Registry (However, the registery is only sent to physicians and not to individuals.)



The following links contain information we have gathered from the FDA Medwatch as well as some of the clinical trials found in

the Zyban Summary Basis of Approval. (More to come in the coming months.) Animal studies were done at various dosing and

did show varying effects on the fetuses.  However, each is disregarded as exposure to maternal toxicity.  



In the MedWatch Report for Wellbutrin SR only (Nov 1, 1997- Feb 24, 2003), there are 163 reports of the mother's use of the

drug affected the fetus.  This figure as well as the total reports of fetal or congential defects equals 341.  However according to the GAO(Government Accounting Office), these figures only represent 1-10% of actual adverse reactions.



To view the information, go to:

http://geocities.com/borg_aw/articles/bupcongclintrial.htm

http://geocities.com/borg_aw/articles/fetuschildrensorted.htm





from http://www.perinatology.com/exposures/Drugs/Bupropion.htm

Bupropion (Wellbutrin ®, Zyban ®)

Antidepressant of the aminoketone class. Used in smoking cessation.

Molecular weight: 276.2

CATEGORY:B



"Reproduction studies have been performed in rabbits and rats at doses up to 15 to 45 times the human daily dose and have

revealed no definitive evidence of impaired fertility or harm to the fetus due to bupropion. (In rabbits, a slightly increased incidence

of fetal abnormalities was seen in 2 studies, but there was no increase in any specific abnormality)." [1]



As of February 2003, 764 pregnancies involving exposure to bupropion had been prospectively registered with The Glaxo

Wellcome Bupropion Pregnancy Registry.  As of June 2003, 154 pregnancies were pending delivery, 213 cases were lost to follow

up, and 397 cases with 401 outcomes were obtained.  The indications for use of bupropion in the latter were depression in 251

patients, smoking cessation in 95 patients, depression and

smoking cessation in 16 patients, bipolar affective disorder in one patient, and unspecified in 34 patients.



Of 322 outcomes involving bupropion exposure in the first trimester there were 261 live births without birth defects, 40

spontaneous pregnancy losses, 11 induced abortions, 1 induced abortion with evidence of Down syndrome on prenatal testing, and

9 infants born alive with birth defects.



The defects in infants born alive included one infant with  bilateral club feet, one infant with  Klinefelter's syndrome (no physical abnormalities), and  7 infants with heart defects (1 abnormal aortic valve thickening with mild aortic insufficiency,  1 ventricular septal defect, 1 trivial pulmonic stenosis with atrial septal defect, 1 coarctation with ventricular septal defect, 1 thickened heart muscle, 1 pulmonary stenosis, and 1 coarctation of the aorta).



The observed proportion of birth defects in pregnancies with prenatal exposure to bupropion in the first trimester was 3.7%.



Birth defects/disorders can happen with this medication as with any other medication or life situation. This information is not meant

to scare, but to inform.  



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