Mark & Associates, P.C. Attorneys At Law

Accutane Birth Defects

Accutane Linked to Severe Birth Defects

Accutane (generic: isotretinoin) is in FDA pregnancy category X.  It is a teratogen and is extremely likely to cause birth defects if taken by the mother during pregnancy. Hundreds of babies have been born with birth defects as a result of exposure to isotretinoin in utero.  In addition to birth defects, Accutane is linked with miscarriage, death of the baby and preterm birth.

Legal Rights for Families Affected by Accutane Birth Defects

If your child was born with an Accutane-related birth defect or if you suffered pregnancy or birth complications as a result of Accutane, contact us for a FREE legal consultation.  Call 1-866-50-RIGHTS (1-866-507-4448) or fill out our Accutane case review form.

Accutane Birth Defects

Accutane can cause many types of severe birth defects.  Some birth defects include cerebral abnormalities, cerebellar malformation, hydrocephalus, microcephaly, cranial nerve deficit, cardiovascular abnormalities, thymus gland abnormality, parathyroid hormone deficiency, abnormality of the skull, abnormality of the ears and eyes, cleft palate, facial dysmorphia, mental retardation, learning deficiencies, and more.

SMART & iPLEDGE Programs

As a result of babies being born with birth defects after being exposed to Accutane in utero, the FDA introduced the SMART program (System to Manage Accutane Related Teretogenicity) in 2002.  The program tested women for pregnancy throughout their Accutane treatment, required two forms of contraception, and counseling and education for patients on the drug. Because SMART was not as effective as desired, the iPLEDGE program was introduced in 2005. The program requires prescribers and patients to be registered with iPLEDGE in order to take Accutane.  Women must take monthly pregnancy tests and if negative, are required to fill the Accutane prescription within seven days. These programs are not foolproof, and they were instituted much too late for many children who were born with birth defects prior to the launch of these programs.  Furthermore, Hoffman La-Roche has known of the risk of birth defects associated with Accutane before the drug went on the market.