Health

Newborn deaths: Viagra should not be used in case of growth retardation

Newborn deaths: Viagra should not be used in case of growth retardation

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Following the interruption of a clinical trial that led to the death of newborns after sildenafil (Viagra®) during pregnancy, the Agence du médicament announced on 7 November that it will not allow intra-uterine growth retardation.

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Present in the famous Viagra® but also in Revatio®, sildenafil has no permission to be used in the treatment of intra-uterine growth retardation. This is what the National Drug Agency announces in a November 7 statement. Explain that this decision was taken after the interruption of a Dutch clinical study that was conducted to see whether the drug substance was important for this indication. The process was "prematurely ended because of one more cases of pulmonary hypertension in the newborn (sildenafil 26.6%, placebo 5.2%) and one increase in 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, "she concluded, and concluded that:

  • Sildenafil is not approved for use in the treatment of intra-uterine growth retardation.
  • Revatio®, Viagra® and their generic medicines should not be used for the treatment of intra-uterine growth restriction.
  • Revatio®, Viagra® and their generic medicines should be used in accordance with the summaries of product characteristics present in their package leaflet.

"An analysis by the scientific committee is under way"

The clinical trial in question was carried out in the summer of 2018 on dPregnant women were randomized into two groups: sildenafil or placebo. Sildenafil was administered 25 mg three times a day for severe intra-uterine growth retardation. The dose used in this study was higher than the recommended doses for Viagra® and Revatio®. "The detailed results of this interim analysis are not yet available and an analysis by the Scientific Committee for follow-up studies is underway "the authority decided.

Revatio® and its generic medicines are indicated for the treatment of adult pulmonary arterial hypertension (PAH) and children between the ages of 1 and 17 years. It must not be used in pregnant women, except when it is absolutely necessary for the treatment of PAH.Viagra® and the generic medicines are indicated in adult men with erectile dysfunction. They are not indicated in women.

Source: – Sildenafil (Revatio and Viagra and its generic medicines) should not be used for the treatment of intra-uterine growth retardation – Letter to health professionals, 7/11/2018, ANSM.

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