A child born with multiple congenital defects including cleft palate , neural tube defect , ASD and microcephaly , which of the following drug was probably used by the mother ?
a. erythromycin
b. isotretinoin
c. ibuprofen
d. metronidazole
A child born with multiple congenital defects including cleft palate , neural tube defect , ASD and microcephaly , which of the following drug was probably used by the mother ?
a. erythromycin
b. isotretinoin
c. ibuprofen
d. metronidazole
Ans: b. isotretinoin
Teratogenicity (Birth Defects)
Isotretinoin is a teratogen and is highly likely to cause birth defects if taken during pregnancy. A few of the more common birth defects that this drug can cause are hearing and visual impairment, missing or malformed earlobes, facial dysmorphism, and mental retardation. Isotretinoin is classified as FDA Pregnancy Category X and ADEC Category X, and use is contraindicated in pregnancy.
The manufacturer recommends that pregnancy be excluded in female patients two weeks prior to commencement of isotretinoin, and that they should use two simultaneous forms of effective contraception at least one month prior to commencement, during, and for at least one month following isotretinoin therapy.
In the U.S. more than 2,000 women have become pregnant while taking the drug between 1982 and 2003, with most pregnancies ending in abortion or miscarriage. About 160 babies with birth defects were born. Consequently, the iPLEDGE program was introduced by the U.S. Food and Drug Administration on 12 August 2005 in an attempt to ensure that female patients receiving isotretinoin do not become pregnant – as of 1 March 2006, only prescribers registered and activated in iPLEDGE are able to prescribe isotretinoin, and only patients registered and qualified in iPLEDGE will be able to have isotretinoin dispensed. The iPLEDGE program also applies to males, even though there has been no evidence of isotretinoin excretion through seminal fluids.
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