Sudafed (Pseudoephedrine): Safe During Pregnancy?

Let's start with the bottom line: It is best to abstain from the use of all medications, drugs, smoking and alcohol during pregnancy.

In a pregnant woman with no medical complications, the common cold is rarely a problem. However, lack of sleep, congestion, cough, fatigue and discomfort can all take their toll. Some natural ways to cope with symptoms of the common cold are: use of a humidifier or steam, saline nose drops for a stuffy nose, saline gargle for sore or itchy throat, chicken soup and rest.

For years, health care providers have felt comfortable recommending pseudoephedrine (Sudafed) for congestion, guaifenesin (Robitussin) for cough and acetaminophen (Tylenol) for pain. Lately, however, pseudoephedrine has received some additional scrutiny, and, for the time being at least, should no longer be offered to pregnant women without a "risk/benefit" discussion. Use of pseudoephedrine should be reserved for severe congestion that significantly impacts sleep and quality of life, and it may not be appropriate for use in the first trimester of pregnancy.

It is important that you speak with your health care provider about any symptoms that you feel need treatment. Only your own midwife or doctor knows you well enough, and knows your situation well enough, to recommend the use of any drug during pregnancy. Some medical conditions adversely affect the pregnancy -- some so seriously that medication, even that which has not been proven absolutely safe, needs to be administered. But it is not the time to self-treat for anything.

Also, do your own research into the safety profile of a recommended drug. Unless absolutely indicated, it is prudent to avoid most drugs during the first trimester. Keep in mind that very few medications have actually been subjected to study in pregnancy.

Some drugs affect developing blood vessels and may cause vessel constriction. In two recent studies, drugs that were considered "vasoconstrictive" included pseudoephedrine, ephedrine, phenylpropanolamine, methylenedioxymethamphetamine (MDMA or "ecstasy"), amphetamines, cocaine and crack.

One fetal defect that can occur when such vessel problems develop is gastroschisis, an abnormality (defect or hole) in the abdominal wall that allows the abdominal contents to protrude outside the body. The abnormality is usually very small, but the exposed contents can range from the stomach to the rectum (almost all of the large and small bowel can become exposed). The malformation is always obvious at birth, but can be detected on ultrasound as early as 14 weeks gestation.

Some associated problems that occur along with gastroschisis are preterm birth, intrauterine growth restriction and cardiac problems. In gastroschisis, the bowel is not contained, but floats freely with the amniotic fluid. Contact with amniotic fluid may cause severe damage to the bowel -- which suffers growth failure, becoming thickened, matted or shortened -- and is associated with diminished function.

Gastroschisis and small intestinal atresia (SIA) are serious congenital anomalies that require surgery, may involve lengthy hospital stays and can be associated with long-term problems. Defects of the small intestine such as gastroschisis may result from vascular disruption in early gestation. It appears that the risk period involves the first 10 weeks of gestation when gastroschisis and small intestinal defects are most likely to develop.

One study (Am J Epidemiol, 2002;155:26-31) found that among mothers of 206 infants with gastroschisis and 126 mothers of infants with small intestinal atresia, infants with gastroschisis had an increased risk of having been exposed to pseudoephedrine (Sudafed) during gestation. The risk for gastroschisis was increased further among infants who had been exposed to pseudoephedrine combined with acetaminophen. The risk of small intestinal atresia was also increased for any use of pseudoephedrine and for use of pseudoephedrine in combination with acetaminophen. (The authors of the study cautioned that underlying maternal illness may have affected the results of this study.)