Prescription Drug Birth Defect Risks Not Always Known to WomenSep 25, 2007 | Parker Waichman LLP drug side-effects when they prescribe medications.
The Food & Drug Administration (FDA) does classify drugs according to their risks for birth defects. But a busy doctor, under pressure to see as many patients as possible, might not take the time to look up a drug’s FDA classification. A wide range of prescription drugs, including some antibiotics, acne medicines, cholesterol drugs, sleep aids and blood thinners, are known to carry a high risk of birth defects.
In a study of nearly 500,000 women, researchers at the University of Pittsburgh Medical Center found that nearly half were not told by their doctors that a particular prescription drug caused birth defects. As a result, a patient might not have taken precautions to avoid becoming pregnant while taking such a medication.
The authors of the study, which was published in the Annals of Internal Medicine, did concede that the research method’s they used could have skewered their findings. The study drew data from insurance company billing records, and doctors might not have used insurance codes to indicate that they had, in fact, counseled a patient about drug side effects. Still, the researchers said that their findings did indicate a need for better communication between doctors and patients.
The researchers looked at billing records of women aged 15 to 44 who had filled more than 1 million prescriptions in 2001. One in six of the patients were prescribed a drug known to cause birth defects. Of the women prescribed high risk drugs, 48% did not receive information from their physician regarding birth defect risks. That was only slightly better than the women who received prescriptions with a low risk of birth defects. Doctors failed to counsel 47% of the women in that group about birth defects.
Internists and family doctors were far more likely to prescribe risky drugs to women of child bearing age. In fact, 48% of the high-risk drugs taken by women in the study were prescribed by internists and family doctors. Obstetricians, psychiatrists and dermatologists were much less likely to prescribe these medications to women in the study.
The research did not see big differences in counseling between high-risk drugs - with one exception. Women taking Isotretinoin, an acne drug better known by its brand name Accutane, got more counseling on its birth risks that any other drug. But Accutane is strictly regulated by the FDA because of the near-certainty that it will cause birth defects. Women are actually required to sign a statement pledging to use contraceptives before a doctor can prescribe Accutane.
While the authors of the Pittsburgh study acknowledge its failings, they say it is a good reminder to any woman given a prescription by her doctor. If the physician does not bring up the subject of the medication’s birth defect risks, the patient should.