Doctors face quandary in prescribing to mothers-to-be

The FDA's push to improve data about the use of medications in pregnancy could get a jump-start from facts collected by several registries.

By Susan J. Landers, AMNews staff. June 10, 2002.

Washington -- When patients have asthma, epilepsy or migraines, medications are available to provide effective control. But if pregnancy enters the picture, all bets are off.

Physicians who counsel pregnant women on the risks posed by medications have it tough. There is very little information available.

"If a woman has diabetes or severe allergies, withdrawing medication is a major medical decision for the doctor," said Michael Shelby, PhD, director of the National Institute of Health's Center for the Evaluation of Risks to Human Reproduction.

"It becomes a problem of trying to balance the effects on a mother's health versus the potential adverse effect on the fetus' health," he noted.

Withholding all medications during pregnancy is not the answer. Resulting health risks would pose a threat to mother and child. But added to the lack of information on drug effects in general is the question of dosage. Women undergo changes during pregnancy that affect blood flow and respiration among other things that leaves physicians in a quandary as to possible dose changes.

The Food and Drug Administration has established a Pregnancy Labeling Team that is grappling with ways to improve the data provided in product labels to reflect the appropriate use of drugs during pregnancy.

Most agree that the current drug labeling system is not accurate for counseling pregnant women. Lewis Holmes, MD, chief of the Genetics and Teratology Unit at Massachusetts General Hospital likens it to a legal defense system for drug companies. If a package insert indicates a drug should not be used during pregnancy, but it is, then the companies will be off the hook should a congenital anomaly result. [...]