Viagra Drug Trial on Pregnant Women Stopped

Eleven babies have died during a Dutch clinical trial researching the effects of the erectile dysfunction drug Sildenafil.

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Researchers were forced to halt the trial when it was discovered that eleven deaths in the trial were linked to the drug. The mothers had been taking part in the trial, which was evaluating the erectile dysfunction drug’s effectiveness on foetal development. The babies were suffering from major growth problems in the womb and were at high risk of stillbirth or dying soon after birth.

Growth Restriction

The growing baby receives its nutrients and oxygen supply from its mother through the placenta. In the cases of these babies, they were not growing at the expected rate due to restricted access to these vital nutrients. This can be caused by a variety of factors, including diabetes, high blood pressure or preeclampsia. Approximately eight per cent of pregnancies are affected by Foetal Growth Restriction (FGR), which can lead to diabetes, hypertension and heart disease for the baby in later life.

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By prescribing the Sildenafil to the expectant mothers, it was hoped this would encourage blood vessels in their placenta to open, supplying the baby with a better blood supply and thus promoting foetal growth.

Lung Disorder

Unfortunately, the Dutch researchers undertaking the trial found that babies who were receiving this drug were developing a lung disorder, adding to the risk of death. Nineteen babies died altogether during the trial – eleven of these were attributed to the lung disorder. Nine other babies in the placebo group died but did not have the lung disorder. Six babies survived whilst still contracting the lung disorder. Three babies in the placebo group developed the lung disorder but survived. These statistics prove just how critical it is to ensure that adaptive phase 1 clinical studies are professionally handled and fully investigated prior to launch. Companies such as Richmond Pharmacology can help with such adaptive phase 1 clinical studies.

The UK conducted a similar clinical trial to the Dutch one but they found that while the drug had no damaging effects, it had no benefits to patients either. The prescription of Sildenafil to pregnant women will be stopped by the Amsterdam University Medical Centre – a conclusion which the UK study also came to.

The progress of babies from the study will continue to be monitored.

 

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