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Developmental toxicity of orally administered sildenafil citrate (Viagra) in SWR/J mice
Faisal Mohamed Abou-Tarboush1, Mohamed Fathy Abdel-Samad, Mokhlid Hamed Al-Meteri
1Department of Zoology, College of Science, King Saud University, P.O. Box 2455, Riyadh 11451, Saudi Arabia.
Abstract:
Normal adult inbred SWR/J mice were used to investigate the teratogenic and other possible toxic effects of various dose levels of sildenafil citrate (Viagra) on fetuses. Multiple dose levels of 6.5, 13.0, 19.5, 26.0, 32.5 or 40.0 mg of sildenafil citrate/kg body weight (which correspond to the multiples of 1, 2, 3, 4, 5 or 6 of human 50 mg Viagra, respectively) were orally administered into pregnant mice on days 7-9, 10-12 or 13-15 of gestation. On day 17 of pregnancy, all fetuses were removed and examined for toxic phenomena (embryo-fetal toxicity) and for external, internal and skeletal malformations. A total of 285 pregnant mice were used in the present study. None of the dams treated with sildenafil citrate at any of the oral dose levels used in the present study died during the experimental period and all dams treated with the drug failed to reveal overt signs of maternal toxicity. Moreover, the results of the present study clearly demonstrate that none of the multiple oral dose levels of the drug at any time interval used has induced any external, internal or skeletal malformations in the fetuses obtained from treated females. However, the dose level of 40 mg/kg body weight of sildenafil citrate has a growth suppressing effect on alive fetuses when it was administered at all the time intervals used in the present study. Furthermore, the dose levels 26.0, 32.5 and 40 mg/kg of the drug have embryo-fetal toxicity when the drug is applied on days 13-15 of gestation. The possible mechanisms involved in the embryo-fetal toxicity and fetal growth suppressing effects of sildenafil citrate were discussed. The results of this study have important implications for the widespread use of this drug.
Insights
Sildenafil citrate (Viagra) did not cause fetal malformations in mice. However, high doses suppressed fetal growth and caused embryo-fetal toxicity, particularly when administered later in gestation.
Area of Science:
- Reproductive Toxicology
- Pharmacology
- Developmental Biology
Background:
- Sildenafil citrate (Viagra) is widely used, necessitating an understanding of its potential effects on fetal development.
- Investigating the teratogenic and toxicological profile of sildenafil citrate is crucial for assessing its safety during pregnancy.
Purpose of the Study:
- To evaluate the teratogenic and other toxic effects of various sildenafil citrate doses on fetal development in SWR/J mice.
- To determine the impact of different administration timings during gestation on potential adverse fetal outcomes.
Main Methods:
- Pregnant SWR/J mice were administered oral doses of sildenafil citrate (6.5-40 mg/kg) on days 7-9, 10-12, or 13-15 of gestation.
- Fetuses were examined on day 17 for external, internal, and skeletal malformations, as well as signs of embryo-fetal toxicity and growth suppression.
- Maternal toxicity was assessed throughout the study period.
Main Results:
- No external, internal, or skeletal malformations were observed in fetuses across all tested dose levels and administration timings.
- Maternal toxicity was not observed in dams treated with sildenafil citrate.
- A growth-suppressing effect on live fetuses was noted at the highest dose (40 mg/kg) across all administration intervals.
- Embryo-fetal toxicity was observed at higher doses (26.0, 32.5, and 40 mg/kg) when administered during days 13-15 of gestation.
Conclusions:
- Sildenafil citrate does not appear to be teratogenic in mice at the tested doses.
- High doses of sildenafil citrate can cause fetal growth suppression and embryo-fetal toxicity, particularly in late gestation.
- These findings have implications for the use of sildenafil citrate in pregnant individuals.
