FDA To Promote Drug Safety

Wednesday, December 20th 2000, 12:00 am

By: News On 6

WASHINGTON (AP) â€” The room full of scientists let out a collective gasp at Dr. Gideon Koren's tragic story: A woman picked up her baby and jumped in front of a subway train. She became suicidal after quitting her antidepression medicine â€” pills she gave up because someone told her, falsely, that they could leach into breast milk and poison her child.

Every day women who are pregnant or breastfeeding wonder if a drug needed for their own health might hurt their baby. Yet few drugs have been properly studied for use during pregnancy â€” not just the big question of fetal safety, but whether a pregnant woman's changing body requires a higher or lower dose.

And even when drugs are found safe, doctors or women may not know that and abandon treatment, sometimes with dire results like the Toronto suicide.

The Food and Drug Administration is developing new rules that should help pregnant women use at least some medicines more safely.

The plan is to require manufacturers to update drug labels annually with any pregnancy safety data, such as independent research or patient case reports, from anywhere in the world. Most companies avoid studying pregnant women and typically just reveal whether animal studies show birth defects, nor do they typically add to their products' labels safety discoveries by independent researchers.

But that won't solve the underlying problem: ``There's ``a dearth of research'' on drugs and pregnancy, laments FDA's Dr. Sandra Kweder, who this month called together Koren, of Toronto's Hospital for Sick Children, and other specialists to debate how to overcome that. ``If most pregnant women knew how little information there is ... they would be greatly surprised.''

Pregnant Americans actually use a surprising number of drugs, yet hardly anyone even tracks what happens to them or their babies.

``The part that troubles me the most is that I can't give patients definitive information because it's not there,'' says West Virginia University clinical pharmacologist Tim Tracy, who leads one of the few studies to track what pregnant women use and thus hunt clues to risks.

Sixty percent of women used at least one prescription drug, not counting prenatal vitamins or iron, at some point in pregnancy, say preliminary results from Tracy's new obstetric database. They're often prescribed by another doctor without telling the obstetrician â€” and include some, like decongestants and an old antidepressant called amitriptyline, that specialists say to avoid.

Almost everyone used some over-the-counter medications, including 25 percent who used the painkiller ibuprofen, another pregnancy no-no because large doses are linked to a heart defect. Also, 57 percent used herbal remedies, which have even less pregnancy safety information than drugs.

Worry is understandable. Catastrophic drug-caused birth defects are rare, but women remember notorious examples like thalidomide, which left babies with flipper-like limbs in the 1960s.

But what too few doctors and women realize is that mothers' diseases themselves can seriously hurt the fetus, say specialists in epilepsy, depression, hypertension and asthma who routinely see women scared off vital treatments â€” sometimes by misinformed obstetricians.

They describe women with artificial heart valves who died from shunning necessary blood thinners, and women who quit epilepsy medicine only to suffer seizures that triggered miscarriage.

Studies show inhaled corticosteroids are less risky than uncontrolled asthma, which can kill the mother or impair fetal growth. Other studies show serotonin-related antidepressants such as Prozac don't cause birth defects or leach dangerously into nursing mothers' breast milk, while untreated depression is a clear risk to the mother.

Some risks are very rare. The mood stabilizer lithium, for example, has a one in 5,000 chance of a heart defect, a worthwhile gamble for some sick women, Koren says.

Other drugs are risky only in the first trimester, when organs are forming.

And then there's the question of dose, which fluctuates with pregnant women's hormonal, metabolism and other bodily changes. Take the antibiotic amoxicillin, for urinary tract infections. Pregnant women need higher doses, but too often doctors don't know that and prescribe a low dose thinking less will reach the fetus â€” a mistake that doesn't cure the infection so women need re-treatment, says FDA's Kweder.

``We have to figure out a way to get this kind of information to women so they can make the best judgment'' on treatments, says Diana Zuckerman of the National Center for Policy Research for Women & Families. ``You have to say, 'My God, why aren't we doing this already?' ''