Can Isotretinoin Cause Birth Defects?

The well-known acne medication isotretinoin (originally marketed as Accutane) should not be taken during pregnancy because of the severe birth defects that it can cause.

In fact, even one dose of isotretinoin can pose life-threatening danger to your unborn child. Injuries caused by this dangerous drug can affect a baby’s brain, ears, eyes, face, heart and skull. This is an enormous range and even one defect in one of these areas can lead to life altering consequences for the injured child and his or her family.

Known Birth Defects Caused by Isotretinoin

The U.S. Food and Drug Administration (FDA) have given an X rating to isotretinoin for good reason. This is because the fetal abnormalities caused by this drug has rendered it not for use during pregnancy. The appalling birth defects caused by this acne medication include:

  • Cleft palate, which is an opening in the roof of the mouth, because the palate did not form completely.
  • Missing ears, small ears or hearing loss.
  • Congenital heart defects, such as ventricular septal defect, atrial septal defect and Tetralogy of Fallot.
  • Micropthalmia, which is when an eye or both eyes have a small eyeball. In some instances, babies are born without eyes. Overall, this drug can cause vision problems.
  • Hydrocephalus, sometimes known as “water on the brain,” is a fluid buildup in the brain, causing the head to swell. Babies with this condition can have intellectual disabilities.
  • Microcephaly is another brain defect, but in this case, the head is smaller than normal, because the brain stops growing. This condition often leads to intellectual disabilities, short stature, poor coordination, seizures and hyperactivity.
  • Facial dysmorphism, can include wide-spaced eyes, small chin, flat nasal bridge or other anomalies.
  • Thymus gland abnormalities, such as a missing or small thymus gland. This gland creates white blood cells that are essential to protecting a person from infection.

These are only a sample of the many heart-wrenching birth defects that this acne medication can cause in newborns. Additionally, early births, miscarriages and fetal death can occur.

Isotretinoin is also known by the common brands Roaccutane, Amnesteem, Claravis, Absorica, Isotroin and Epuris. Consult your physician immediately if you are taking any of these medications and are pregnant or are planning to have children.

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[Did You Know? The original isotretinoin brand, Accutane, was so controversial that it was discontinued in 2009.]

Farrell & Patel – Birth Injury Lawyers

Source: http://www.rochecanada.com/fmfiles/re7234008/Research/ClinicalTrialsForms/Products/ConsumerInformation/MonographsandPublicAdvisories/Accutane/Accutane_PM_E.pdf