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wellbutrin question fda categories...so confused help please!! Rate Topic: -----

#1 User is offline   tiredoftherapy21 

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Posted 06 July 2007 - 10:42 AM

I have a question, I am getting confliciting information on whether wellbutrin xl is category b for pregnancy or a category c, some sites say it is category b, some say it is category c,which one is it??and what do you base that off of??

please someone answer me..if you can.
MY CRAZY LIST:: panic disorder w/ agoraphobia, chronic ptsd, schizoaffective disorder(depressive type), bpd, social phobia/anxiety, anorexia nervosa , dissociation
the reason I am in pain all the time::
fibromylagia, cervical dysplasia, scoliosis, hpv, endometriosis, lupus

medications I have tried:: effexor xr, zoloft, prozac, lithium, seroquel, cymbalta, lexapro, klonopin, wellbutrin sr, ativan , zyprexa, abilify, risperdal, wellbutrin xl , xanax, buspar, paxil, geodon, celexa, remeron, emsam patch
current meds:: luvox 50 mg 1x

#2 User is offline   AirMarshall 

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Posted 06 July 2007 - 11:37 AM

Links to all the antidepressants are pinned at the top of the AD forum above.

Here is the PI sheet for Wellbutrin XL: http://us.gsk.com/pr...ellbutrinXL.pdf

Here is the Pregnancy info:

Quote

Pregnancy: Teratogenic Effects: Pregnancy Category C. In studies conducted in rats and rabbits, bupropion was administered orally at doses up to 450 and 150 mg/kg/day, respectively (approximately 11 and 7 times the maximum recommended human dose [MRHD], respectively, on a mg/m2 basis), during the period of organogenesis. No clear evidence of teratogenic activity was found in either species; however, in rabbits, slightly increased incidences of fetal malformations and skeletal variations were observed at the lowest dose tested (25 mg/kg/day, approximately equal to the MRHD on a mg/m2 basis) and greater. Decreased fetal weights were seen at 50 mg/kg and greater.
When rats were administered bupropion at oral doses of up to 300 mg/kg/day (approximately 7 times the MRHD on a mg/m2 basis) prior to mating and throughout pregnancy and lactation, there were no apparent adverse effects on offspring development.

One study has been conducted in pregnant women. This retrospective, managed-care database study assessed the risk of congenital malformations overall, and cardiovascular malformations specifically, following exposure to bupropion in the first trimester compared to the risk of these malformations following exposure to other antidepressants in the first trimester and bupropion outside of the first trimester. This study included 7,005 infants with antidepressant exposure during pregnancy, 1,213 of whom were exposed to bupropion in the first trimester. The study showed no greater risk for congenital malformations overall, or cardiovascular malformations specifically, following first trimester bupropion exposure compared to exposure to all other antidepressants in the first trimester, or bupropion outside of the first trimester. The results of this study have not been corroborated. WELLBUTRIN XL should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

To monitor fetal outcomes of pregnant women exposed to WELLBUTRIN XL, GlaxoSmithKline maintains a Bupropion Pregnancy Registry. Health care providers are encouraged to register patients by calling (800) 336-2176.
Labor and Delivery: The effect of WELLBUTRIN XL Tablets on labor and delivery in humans is unknown.

Nursing Mothers: Like many other drugs, bupropion and its metabolites are secreted in human milk. Because of the potential for serious adverse reactions in nursing infants from 17
WELLBUTRIN XL Tablets, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.


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#3 User is offline   Loon-A-TiK 

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Posted 06 July 2007 - 12:47 PM

yeppers, i wanted to give you another reply, from all my research, WB is *probably* safe, but they don't have a record of it as of yet, so it is a C.

i've looked into it because i take WB and would like to become a mother someday.
DX-BP1 w/psychotic symptoms, PTSD, ADD (Inattentive), and body dysmorphic disorder
Daily RX- WB 300mg, Lamictal 400mg, Abilify 20mg, Adderall XR 30mg, Inderal 10mgx2, Nuvaring
a multi-vitamin, hair/skin/nails vitamin, super 50-b complex vitamin, flax oil

prn- Zyprexa 10-20mg for emergencies

In memory of my dad, BP1 suicide. I love you and miss you!

EX RX- Seroquel, Risperdal, Geodon (master of all that is evil), Zyprexa (the good stuff), Zyprexa Zydis, Trazadon, Depakote, Lithium, Serzone, Paxil, Effexor, Lexapro, Haldol, Strattera, Topamax, Symmetrel, other old school ACs, and more I can't remember now

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