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Decongestants May Cause Birth Defects

A new study reveals that using over-the-counter decongestants during pregnancy may increase the risk of a child being born with birth defects. Scientists at the Slone Epidemiology Center at Boston University interviewed nearly 20,000 mothers to find out what drugs they had taken while they were pregnant. What they found was a link between several types of over- the-counter cold medicines and certain rare birth defects.

Phenylephrine is a decongestant commonly found in cold medicines such as Sudafed. The study showed that women taking this medication during their first trimester were eight times likelier to give birth to a child with endocardial cushion defect – an abnormal heart condition in which the walls separating the chambers of the heart are poorly formed or absent.

Pseudoephedrine (also in Sudafed) was linked to a 3-fold higher risk of limb reduction defects –the failure of an arm or leg of a fetus to form completely during pregnancy. The defect is referred to as a “limb reduction” because a limb is reduced from its normal size or is missing.

Imidazolines are used in eyedrops and nasal sprays. Babies born to mothers who used these products were twice as likely to develop tracheoesophageal fistula – a birth defect in the throat which causes an abnormal connection between the trachea (windpipe) and esophagus (the tube that carries food.) This condition may allow food within the esophagus to pass into the trachea (and on to the lungs) or alternatively, air in the trachea may cross into the esophagus, and enter the digestive system.

What are my risks?

The author of the study, Dr. Allen Mitchell, cautions pregnant mothers about the use of these and other over-the-counter medicines, but feels that more research is necessary:

“The fact that medications such as decongestants are typically and widely available for use without a prescription and do not require consultation with a healthcare provider should not be assumed to mean they are safe with respect to the fetus, since there are still relatively few studies that examine the risks and relative safety of these ‘over-the-counter’ medications, which are more wide used in pregnancy than prescription medications.”

It should be noted that these are very rare birth defects, in some cases only affecting 1 out of 1000 births. But in a country with around 4 million births each year, that translates to 4000 children who may be at risk.

Always use caution

The CDC recommends that women who are or plan to be pregnant (as well as nursing mothers) speak with their doctor if they have taken any medication or are thinking of taking any medication. This includes prescription and over-the-counter medications, in addition to dietary or herbal products. The doctor and patient should discuss whether the benefits of a drug or supplement outweigh any risks to the fetus.

The FDA has prepared this downloadable brochure about medicines and pregnancy.



“Decongestants in pregnancy linked to birth defects” by Kathryn Doyle, Reuters July 22, 2013.