Neonatal deaths: Viagra should not be used in case of stunting

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Following the interruption of a clinical trial that led to the death of newborns after taking sildenafil (Viagra®) during pregnancy, Agence du médicament announced on November 7 its decision to do not allow this substance in the event of intrauterine growth retardation.

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Present in the famous Viagra® but also in Revatio®, sildenafil has no authorization to use in the management of intrauterine growth retardation. This is what the National Agency for Drugs announces in a statement of 7 November. Explaining that this decision was made after the interruption of a Dutch clinical trial conducted to verify if the pharmaceutical substance was interesting for this indication. The trial had been "terminated prematurely due to a more cases of pulmonary hypertension in the newborn (sildenafil 26.6%, placebo 5.2%) and one increased neonatal mortality before discharge from the hospital (sildenafil 26.8%, placebo 14.3%) observed in the sildenafil arm of the study compared to the placebo group, "he concluded, concluding that:

  • Sildenafil is not approved for use in the treatment of intrauterine growth retardation.
  • Revatio®, Viagra® and their generics should not be used to treat intrauterine growth restriction.
  • Revatio®, Viagra® and their generics should be used according to the summaries of the product characteristics in their package leaflet.

"An analysis of the scientific committee is under way"

The clinical trial in question was conducted during the summer 2018 to dPregnant women randomized into two groups: sildenafil or placebo. Sildenafil was given at 25 mg three times daily for severe intrauterine growth retardation. The dose used in this study was higher than the recommended dose for Viagra® and Revatio®. "The detailed results of this interim analysis are not yet available and an analysis of the scientific committee for follow-up studies is underway "concluded the authority.

Revatio® and its generics are indicated for the treatment of pulmonary arterial hypertension of the adult (PAH) and children aged 1 to 17 years. It should not be used in pregnant women except when extremely necessary for the treatment of PAH.Viagra® and its generics are indicated in adult men with erectile dysfunction. They are not indicated in women.

Source: – Sildenafil (Revatio and Viagra and its generics) should not be used to treat intrauterine growth retardation – Letter to health care workers, 11/7/2018, ANSM.

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