Europe. The European Committee for Proprietary Medicinal Products (CPMP) has finalised a EU-wide review of loratadine that was initiated by Sweden due to safety concerns of hypospadias in new-born boys born to mothers receiving loratadine during pregnancy. The CPMP has concluded that a causal relationship could neither be confirmed nor excluded. However, the Committee advises that as a precautionary measure the product information for loratadine should be revised to state that the use of loratadine during pregnancy is not recommended; combinations of loratadine and pseudoephedrine should be contraindicated in pregnancy since pseudo-ephedrine decreases maternal uterine blood flow. A similar parallel review for desloratadine could neither establish nor exclude a causal relationship with hypospadias; the CPMP has advised against using this drug also in pregnancy.

Reference:
EMEA Press Release EMEA/CPMP/5732/03/Final, 20 November 2003. Available from URL: http://www.emea.eu.int