Comparative study of propyphenazone and paracetamol on fetal development

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Objective: Paracetamol and propyphenazone are the active ingredients in over the counter oral antipyretic and analgesic drugs. The effects of paracetamol and propyphenazone, alone and in combination have been assessed in experimental animal model.

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Methods: The tested substances were treated using stomach tube, in Tween 80 solution, one time per day, on day 8 to 14 of pregnancy in three doses: PO — 3.5 mg/kg body weight, Pl — 35.0 mg/kg b.w., P2 — 350.0 mg/kg b.w. for paracetamol; RO — 2.1 mg/kg b.w., Rl — 21.0 mg/kg b.w., R2 —210.0 mg/kg b.w for propyphenazone. There were three groups which received the combination of the drugs in constant proportion 5:3: PORO, P1R1, P2R2. The two control groups were done: T — receiving Tween 80 solution, C — untreated control. The dames were sacrificed on day 21 of gestation and the number of implants, resorptions, and the live fetuses were counted. The weight of fetuses and placentas, the lengths of fetuses and their tails were checked. The fetuses were fixed either in Boin’s fluid for study of viscera organs by Wilson ’s razor bland technique or in alcohol for study of the skeleton by alizarin red S staining. The Student’s t-test and Mann-Whitney’s test were used in statistical verification.

Results: There was a statistical (p<0.05) difference in body weight in P1R1, body length in P2, RO, Rl, P1R1, tail length in P2R2, placenta weight in P2R2 compared to control groups without any visceral and external macroscopic malformation.

Conclusion: The combination of paracetamol and propyphenazone provided embryotoxic effect as a paracetamol alone in the highest doses.