... July 2013.. I realised that I have conceived around 15th or 16th July and now I am 7 weeks pregnant... Should I continue with the pregnancy .. Is it safe ..will this dose affect my baby? What are the statistics? Is there any test that I can do to know the levels of isotretinoin deposited in my body / blood with this dosage ? What are my chances of having a normal baby after taking this dosage that I have ?
You need to consult with gynecologist. From the literature:
Known human teratogen; extremely high risk of severe birth defects if administered during pregnancy; may be life-threatening.201 203 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)
iPLEDGE restricted distribution program is in effect to help ensure that fetal exposure does not occur.201 203 The iPLEDGE program specifies monthly requirements for the prescribing clinician, patient, and pharmacist.201 (See Restricted Distribution under Dosage and Administration.)
Contraindicated in female patients who are or may become pregnant and in female patients of childbearing potential, unless they comply with all the special conditions required by the iPLEDGE restricted distribution program.201 202 203
Pregnancy must be excluded by monthly negative serum or urine pregnancy test results and prevented by simultaneous use of 2 forms of reliable contraception.201 203 (See Advice to Patients.)
If pregnancy occurs, immediately discontinue drug and refer patient to an obstetrician/gynecologist experienced in reproductive toxicity for further evaluation and counseling.201 202 203 (See Pregnancy under Cautions.)
Fetal/Neonatal Morbidity and Mortality
Extremely high risk of severe birth defects (possibly life-threatening) if pregnancy occurs while receiving isotretinoin in any amount even for short periods of time; teratogenicity generally characterized by malformations involving craniofacial, cardiovascular, thymus and parathyroid gland, and CNS structures.100 143 144 145 146 147 173 203 Cases of IQ scores <85 with or without obvious CNS abnormalities also have been reported.203 Spontaneous abortions and premature births also reported.203 Contraindicated in female patients who are or who may become pregnant.
See the MedWatch notification at the beginning of the monograph.
Report all pregnancies during or up to 1 month following therapy to FDA Medwatch Program at 1-800-FDA-1088 and also to the iPLEDGE pregnancy registry at 1-866-495-0654 or through the program’s website
- Isotretinoin Information for Consumers
- Isotretinoin Information for Healthcare Professionals (includes dosage details)
- Side Effects of Isotretinoin (detailed)
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