其 他 安 全 警 示
|
| |
| The United Kingdom: Sildenafil (Revatio and Viagra): reports of persistent pulmonary hypertension of the newborn (PPHN) following in-utero exposure in a clinical trial on intrauterine growth restriction (English Only) |
| |
Medicines and Healthcare products Regulatory Agency (MHRA) announces that data from an independent clinical trial has shown potential harm, including increased risk of persistent pulmonary hypertension of the newborn (PPHN) and increased mortality, when sildenafil is used in pregnancy for early-onset intrauterine growth restriction (IUGR).
Interim data from an independent clinical trial, the Dutch STRIDER (Sildenafil TheRapy in Dismal prognosis Early-onset fetal growth Restriction) study, suggest an increased risk of PPHN and neonatal mortality when sildenafil was used in pregnancy for intrauterine (fetal) growth restriction compared with placebo. The group assigned to sildenafil had an incidence of 17 cases of PPHN in 64 babies (27%), including 11 deaths before discharge. In the placebo group, 3 of 58 babies (5%) had PPHN, with no reported deaths before discharge. These findings occurred in the absence of any benefit shown on the primary endpoint of neonatal survival until term age.
The Dutch STRIDER study was one of 5 independent studies by an international collaboration investigating the use of sildenafil for this unauthorised use. The 5 trials in the STRIDER Consortium were undertaken in the UK, Ireland, The Netherlands, New Zealand/Australia, and Canada. Pregnant women were randomised to generic sildenafil or placebo. Sildenafil was given in a dose of 25 mg three times a day to pregnant women for the treatment of severe intrauterine (fetal) growth restriction.
Details of the interim analysis of the Dutch STRIDER study are not yet available and the analysis by the STRIDER consortium of studies is awaited. A letter has been sent to relevant healthcare professionals to inform them of this information and that sildenafil should not be used in intrauterine (fetal) growth restriction.
Healthcare professionals are advised:
- sildenafil (Revatio and Viagra) is not authorised for the treatment of IUGR.
- Revatio for the treatment of pulmonary arterial hypertension is not recommended in pregnancy unless strictly necessary; Viagra is not authorised for use in women.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/sildenafil-revatio-and-viagra-reports-of-persistent-pulmonary-hypertension-of-the-newborn-pphn-following-in-utero-exposure-in-a-clinical-trial-on-intrauterine-growth-restriction
In Hong Kong, there are 82 registered pharmaceutical products containing sildenafil, and all products are prescription-only medicines. So far, the Department of Health (DH) has received 2 cases of adverse drug reaction related to sildenafil, but these cases are not related to PPHN. In light of the above MHRA’s announcement, letters to inform local healthcare professionals will be issued. The DH will remain vigilant on the conclusion of the study and safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Thursday, Nov 15, 2018
Issued at HKT 17:00
|
| |
|
