Oral Cleft Birth Defect Side Effects Not Tied to Asthma Drugs: Study

A nationwide study of births in Denmark has ruled out a potential link between corticosteroids used to control asthma in pregnant women and a risk of oral cleft birth defects, such as cleft palate and cleft lip.

The findings for the 12-year study were published online by the Canadian Medical Association Journal on April 11. The Danish researchers determined that there was no statistically significant link between corticosteroid asthma medications and a higher incidence of cleft palate and cleft lip among children born to women who used the drugs.

The researchers collected data on all 832,636 live births in Denmark from January 1, 1996 to September 30, 2008. They found that exposure to corticosteroids during the first trimester of the mother’s pregnancy occurred 51,973 times, but only in 84 cases did the mother give birth to a child with cleft palate or cleft lip.

No causal connection was found between use of the asthma drugs and oral cleft birth defects.

Asthma affects 20 million Americans, including 6.5 million children. It is a chronic disease with symptoms like wheezing, difficulty breathing and spasms, which can severely limit activities and impact quality of life. Corticosteroids are typically used in asthma controller medications in inhalers.

Cleft palate and cleft lip occur when parts of the lip or palate fail to completely fuse together. The defect results in the child being born with defects as small as a notched lip to extreme as an open groove that goes from the roof of the mouth to the nose. Cleft palate and cleft lip can cause problems eating and talking and can increase the risk of ear infections, resulting in the need for corrective surgery.

In recent weeks, attention has been placed on cleft palate and cleft lip birth defects following the FDA’s warnings that pregnant women taking the epilepsy drug Topamax are at increased risk of giving birth to a child with those birth defects.

Topamax (topiramate) was first approved for treatment of epilepsy, which is a neurological disorder characterized by recurrent uncontrolled seizures. In 2004, the FDA approved Topamax for an additional use of treating severe headaches known as migraines. It is also used off-label by many doctors to treat bipolar disorder. Generic forms of the drug began to appear in 2006.

On March 4, the FDA announced that new warnings would be added to the medication’s label about the risk of oral clefts from Topamax when the medication is used during the first trimester of pregnancy, a time when many women do not even know they are pregnant. The FDA urged doctors to avoid giving Topamax to pregnant women or women who are of child-bearing age and at a high risk of pregnancy, as alternative drugs may not carry the same risk for the unborn child.

A number of women who have given birth to children with a defect or malformation after using the drug while pregnant are considering a potential Topamax lawsuit against the drug makers as a result of their failure to research the pregnancy risks associated with the medication or adequately warn about the risk of Topamax cleft palate and lip problems.