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Accutane Can Still Cause Birth Defects

Accutane, or Isotretinoin, is a medication that is used to treat severe cases of recalcitrant nodular acne. As a retinoid, it can also be used to prevent and treat certain forms of cancer. Unfortunately, Accutane is also a potent teratogen, which means that it can affect the development of a fetus even just ten days after its conception. If a woman takes Accutane, Roaccutane, or any generic Isotretinoin product while pregnant, her child may develop a debilitating birth defect.

Accutane is known to cause the following birth defects:

  • Heart defects
  • Facial dysmorphism
  • Cleft palate
  • Hydrocephaly
  • Eye abnormalities
  • Brain defects
  • Microcephaly
  • Ear abnormalities
  • Cognitive disabilities
  • Nerve system malformations

It’s recommended that any mothers who were using an Isotretinoin medication before their pregnancy should refrain from breastfeeding their babies.

The FDA Regulates Accutane

In 2006, the FDA created a special program called iPLEDGE that mandated new requirements for prospective Accutane patients. Any woman who is interested in using this Isotretinoin product must have a prescription for birth control or be willing to abstain from sexual intercourse. A female patient also needs to take a monthly pregnancy test for so long as they use the drug. The physician prescribing the drug needs to update the patient’s records, enter the test results, and receive authorization from the iPLEDGE program before prescribing more Accutane.

However, a new study published in JAMA Dermatology reveals that women taking Accutane are still getting pregnant: “There was a total of 6740 pregnancies among women taking isotretinoin reported to the FDA from 1997 to 2018, peaking in 2016 (768 pregnancies) before settling into a range of 218 to 310 annual reports of pregnancy after 2011.”

Which Parties Can Be Held Legally Responsible for a Birth Defect?

Although Roche Pharmaceuticals, a subsidiary of Hoffman-Roche, took Accutane off the market in 2009, various pharmaceutical companies are using the drug’s original formula to produce and distribute generic Isotretinoin products. Like Accutane, these products can also lead to the development of severe congenital disabilities.

Accutane is currently being sold under the following names:

  • Amnesteem
  • Claravis
  • Sotret

Pursue Justice & Damages with Shrader & Associates, L.L.P.

Contact the trial-tested pharmaceutical litigation lawyers at Shrader & Associates, L.L.P. if you or your child has suffered harm after taking an Isotretinoin medication. We can help you hold the manufacturer responsible for their negligent actions and choices.

Contact Shrader & Associates, L.L.P. at (877) 958-7920 to schedule a free consultation. We serve clients nationwide from our offices in Texas and Illinois.


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