Abstract
- When a pregnant woman suffers from mild to moderate pain, and when simple non-drug measures are ineffective, paracetamol is the drug of first choice. Data from epidemiological and animal studies are reassuring regarding the risk of malformations. In late 2010, a link was suggested between paracetamol exposure in utero and the occurrence of cryptorchidism, a common male urogenital birth defect that usually resolves during the first year of life.
- Does paracetamol exposure in utero increase the risk of birth defects, particularly cryptorchidism persisting beyond one year of age? To answer this question, we conducted a review of the literature using the standard Prescrire methodology.
- The results of about 10 animal teratogenicity studies are reassuring. Some studies yielded conflicting results for testicular abnormalities.
- Two cohort studies including a total of nearly 49 000 boys showed no increase in the risk of persistent cryptorchidism after paracetamol exposure in utero. A case-control study showed a link with cryptorchidism in a subgroup of boys exposed to paracetamol in utero for more than 15 days; the analysis was not performed in boys with persistent cryptorchidism.
- Six cohort studies and 11 case-control studies including approximately 38 000 women showed no increase in malformations among children exposed to paracetamol in utero compared to unexposed children.
- Available data show no conclusive link between paracetamol exposure in utero and the risk of childhood asthma.
- Overall, data available in early 2012, especially those from epidemiological studies, are reassuring on the use of paracetamol during pregnancy. Paracetamol remains the analgesic and antipyretic medication of first choice for pregnant women when nondrug measures are ineffective.
©Prescrire 1 July 2012
"Paracetamol during pregnancy: no particular danger for the child" Prescrire Int 2012; 21 (129): 186-190. (Pdf, subscribers only)