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Cold Medicines and Birth Defects

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Certain birth defects have been shown to have an 8 fold increased risk of occurring when oral and nasal decongestants are used during the first trimester of pregnancy, according to a new case-controlled study by the Harvard School of Public Health. The findings support previous suspected associations between first trimester use of phenylephrine (such as found in Neo-Synephrine, Sudafed, Sudogest), and endocardial cushion defects, between first trimester use of phenylpropanolamine (such as found in Rhinocaps, Sinapils, Saleto-D, Coricidin D, Sinulin, Conex, Contuss, Dextrim, Gentab) and ear defects, and between first trimester use of phenylpropanolamine and pyloric stenosis. In fact, the risk of pyloric stenosis in newborns was greater with the use of any intranasal decongestant.

The study points out that, even with the 8-fold increase in risk, the absolute number of babies exposed to these drugs who are born with birth defects is still small. However small, the important point for pregnant women to remember is that they should ask their doctors about the medications they take so as to minimize the risk of congenital birth defects. The developing fetus is very sensitive to medications that, although tested and approved for adults usage, have not been tested during pregnancy. The relative low incidence of these birth defects makes it hard to demonstrate increased risk of harm unless large enough populations are studied.

While women should not avoid taking medications that are necessary to treat specific medical conditions during pregnancy, they must be careful to not assume that common medications that readily available for consumption are safe. Sometimes common adult medications can be dangerous drugs for a fetus.


I am glad this blog was written. Pregnant woman have to be very aware of everything they take and drug companies need to properly warn about the dangers of drugs in pregnancy.

This study would seem to lend support to the idea that the anti nausea drug Bendectin which contained an antihistamine and which was the subject of the Daubert decision of the US Supreme Court was INDEED a human teratogen. The rarity of these birth defects in the general population is so rare that it is simply not possible to conduct an epidemiologic study large enough to detect the link. Under the US Constitution it should be the exclusive province if the jury not the judiciary to determine issues if fact in civil claims.

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