· .. and the FDA renews its warnings about the teratogenicity of isotretinoin

Isotretinoin, approved for the treatment of severe recalcitrant cystic acne, is known 10 be teratogenic in humans. Up to July 1984 the FDA had received reports of 21 major birth defects , 24 spontaneous abortions and 24 pregnancies with normal outcomes in women taking isotretinoin dlJring pregnancy. Birth defects included small or absen1 ears, facial dysmorphia (small mouth and lower jaw, cleft palate) , neurological injury and cardiovascular defects . The apparently normal babies may not have been exposed during the critical period (28-70 days from the last menstruation) or may not have been followed up for long enough. Five other apparently normal infants were later found to have defects (brain injury, blindness , facial palsy , deafness, ventricular septal defect) .

Exposure to isotretinoin is less likely to be reported it there is a spontaneous abortion or a normal outcome. Pregnant women who realise they have been exposed to isotretinoin often have induced abortions. Of 25 women who reported exposure before the outcome was known, but did not have Induced abortions , 10 had a normal outcome (1 infant died unexpectedly at 7 weeks of age), 11 had spontaneous abortions and 4 had infants with birth

defects. New labelling changes strongly recommend that a

pregnancy test should be performed no more than 2 weeks before isotretinoin treatment is started. Further, effective contraception should be used for at least 1 month before, during and after isotretinoin treatment. New patient literature is being distributed. The FDA has also advised all blood donation establishments that, because of the possibility of isotretinoin being present in the blood for long periods, any donor using isotretinoin should not give blood until at least 1 month after the end of treatment.

The FDA is continuing to monitor pregnancies associated with isotretinoin and advises that isotretinoin ' . . . should be reserved only for those patients with severe recalcitrant acne who are unresponsive to conventional therapy . . . ' and that 'women of childbearing age should be fully informed of the drug's teratogenicity'. FDA Drug Bulletin 14: 15·16 (Aug /984)