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The Other Drug Moms

Since Testing Just Isn't Done on Pregnant Women, It's Tough to Figure Which Medications Are Safe


Becky Jensen is an experienced traveler in a medical no man's land.

Four years ago, problems with her pregnancy led doctors to prescribe numerous medications--such as hormones and antibiotics--none of which, Jensen noted with alarm, had been tested for safety in pregnant women.

Having miscarried five times previously, Jensen became so distraught over her dilemma--either lose her baby or take drugs that might harm the baby--that she followed her doctor's advice to take yet another medication: a mild tranquilizer so she wouldn't miscarry due to stress.

The Arcadia woman finally reached her emotional breaking point the day her husband went to a pharmacy to pick up some baby aspirin, which Jensen's doctor told her would help increase blood supply and circulation to the fetus.

"The pharmacist knew I was at home pregnant. He told my husband, 'Oh, no, Becky can't take this because she's pregnant! These are contraindicated because they will cause bleeding in the fetus.' I called my obstetrician to complain and he assured me that I should take them. But it was a month before I @could swallow a pill. It said right there on the package insert: Do not take if you are pregnant."

The no man's land where Jensen resided for seven months--eventually giving birth to a premature but healthy son--is also known as the field of maternal-fetal toxicology. It is the place where a few dozen gutsy researchers confront a hushed-up reality: An estimated half of all pregnant women consume medications despite the fact that there is almost nothing known about most drugs' safety during pregnancy.

Even dissected into smaller pieces, the issues confronting researchers in this field are overwhelming:

* Which drugs--legal, illegal, prescription or over-the-counter--can harm a fetus?

* Which drugs are safe for pregnant women who need treatment for an illness or relief from suffering?

* How do you answer these questions when it's considered unethical to test new drugs on pregnant women?

On the 25th anniversary of the removal of thalidomide from the marketplace, there is a consensus building that these hard questions can no longer be ignored. Thalidomide was the medication for morning sickness prescribed to thousands of pregnant women in the 1950s that was later linked to severe birth defects.

That disaster, experts say, undercut legitimate efforts to better understand medication in pregnancy. Gradually, however, there is a recognition that ignorance is not bliss.

Research from a few respected maternal-fetal toxicology research programs in North America has whetted the thirst for more knowledge. And earlier last month, the U.S. Centers for Disease Control and Prevention launched a five-year, six-center project to collect data on possible factors relating to birth defects, with a special focus on medications.

Perhaps most significantly, the pharmaceutical industry is dipping a cautious toe into the testing of drugs in pregnant women before products move to the marketplace, a concept once considered an ethical quandary--pitting a woman's health against her fetus' welfare--that defied a solution.

"There is this huge tension between the need for authoritative information and this big, black hole," says Dr. Gideon Koran, a Toronto-based researcher at the forefront of maternal-fetal toxicology. "Since the thalidomide disaster, the general gestalt of the community is that every drug is a potential thalidomide and women should not take medications while pregnant. But what is happening now is the larger community, both lay people and medical professionals, is beginning to understand the risk of not doing anything about these issues."


The fact is, say experts in the field, pregnant women are, for a variety of reasons, taking drugs.

"Legal drugs are widely used during pregnancy," says Dr. Allen Mitchell, director of the Birth Defects Study at the Slone Epidemiology Unit at Boston University. "I think what people don't appreciate is that the most commonly used drugs are probably the least studied."

The patterns of drug usage in pregnancy usually fall into one of three categories: illicit drug use, especially of alcohol; use of medications--often over-the-counter drugs--that women unwittingly take in the first month or two of pregnancy before they realize they are pregnant; and the use of medications to treat illness, disease or suffering.

"More than half of all pregnancies are unplanned, so millions of women use medications because they were not planning to become pregnant. We estimate than more than 1 million babies, in the United States and Canada, are exposed to drugs in the first or second month of pregnancy," Koren says.

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