CDC finds no link between loratadine and hypospadias

June 1, 2004

Contrary to an earlier report, loratadine does not seem to increase the risk of hypospadias in the male offspring of pregnant mothers who took it 1 month before or 3 months after getting pregnant, according to this Centers for Disease Control and Prevention analysis of data on more than 2,000 boys.

Hypospadias generally occurs in about 7 of every 1,000 male infants in the US. A study from Sweden in 2002 reported the rate to be about twice that in males born to women who took loratadine during pregnancy. A 2003 study using data from four countries found the rate to be the same as that for the general population. To further assess any possible association, the CDC analyzed data from the National Birth Defects Prevention Study, an ongoing, multistate, case–control study of environmental and genetic risk factors for major birth defects.

Not only was loratadine not associated with any increased risk, but use of any nonsedating or sedating antihistamine was not associated with an increased risk for hypospadias.

Centers for Disease Control and Prevention. Evaluation of an association between loratadine and hypospadias—United States, 1997-2001. MMWR Morb Mortal Weekly Rep. 2004;53(10):219-221.