Drug Allegedly Causes Stroke In Infant

Pharmacology Expert WitnessThis case involves the care of a neonate born at a hospital in Montana. The neonate needed to undergo a great vessel switch after birth in order to correct a genetic defect. During the surgery, the surgeons noticed unusual bleeding. The physicians administered Novo7 to assist in minimizing the surgical time. The drug immediately caused a stroke of the cerebral artery, rendering the child severely disabled.

Question(s) For Expert Witness

  • 1. According to the literature, is administering this drug to a neonate a safe and effective treatment option in excessive bleeding?

Expert Witness Response E-008734

Expert-ID: E-008734

Depending on the nature of the genetic abnormality, the pharmacological effect of the Novo7 could be altered, or its dose could be incorrect for the patient’s metabolism, or the sensitivity to the Novo7 itself could be altered. There are other considerations as well, such as whether the stroke was caused by failure of the drug, excessive concentrations of the drug, or if the surgery itself was somehow responsible for the clot (if it was a clot). I specialize in complex cases where there are many interacting variables and pharmacology can help sort them out.

Expert Witness Response E-008736

I have quite extensive experience with Novo7 as we have used it in the operating room, ICU, and emergency department for refractory bleeding. Based on the current literature, Novoseven for neonates is only suggested for patients with a hemophilia disorder. In patients that do not have this particular bleeding disorder, the adverse effects (i.e. clot formation/stroke) as described in this case prevail and will occur.


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