- A study published in Scientific Reports found significantly lower PCSK9 levels in rat embryos with neural tube defects (NTDs), Cardiobrief's Larry Husten notes.
- This has raised concerns about whether it is safe for pregnant women to take a PCSK9 inhibitor for treatment of hypercholesterolemia during pregnancy.
- Neither Sanofi, which markets Praluent, or Amgen/Regeneron, which market Repatha, have definitive data in their labels about the impact of their drugs on neonates. However, Sanofi is currently planning a post-marketing study to determine whether there are any drug-associated risks for the offspring of women who take Praluent during pregnancy.
Although the labels for the currently approved PCSK9 inhibitors don't warn about potential birth defects, they do state they have not been tested in pregnant women. Statins, the usual type of drug to treat high cholesterol, are contra-indicated during pregnancy.
PCSK drugs are relatively new and safety data, especially including data on teratogenicity, are not fully developed. Generally, post-marketing studies are a stipulation of approval for many drugs, if there is not yet a comprehensive data set. For women who require treatment for extreme hypercholesterolemia and hope to become pregnant, this new data could present a hard choice.