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Pregnancy and medications

Monday, December 21st, 2009



Don’t drink coffee, don’t eat tuna, don’t clean up cat litter, don’t get too stressed out – pregnant women hear many messages about the impact of their choices on a developing baby. For pregnant women with medical conditions, there’s even more at stake. They may have to balance their own health needs with those of the fetus – without much information to guide them. From WHYY’s health and science desk – Kerry Grens and Maiken Scott join up on an in-depth look at pregnancy, medications, and research. First Maiken takes a look at mood disorders.

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Looking back, Anne Hildenbrandt can see signs that she was chronically depressed long before she got pregnant. She struggled during her first two pregnancies, but as she expected her third child, her symptoms became unbearable.

Hildenbrandt: All of a sudden, it just hit me like a wall. I couldn’t leave my house, so I’d find every excuse to call out of work. One night I just walked in and I was just so – I guess the anxiety overtook me and I couldn’t stop crying.

Typically these symptoms would be treated with an anti-depressant or an anti-anxiety medication. But some evidence suggests those drugs can harm a developing fetus.

Deborah Kim is the medical director of the perinatal mood and anxiety disorder clinic at the University of Pennsylvania.

Kim: The baby is exposed in much smaller amounts than what you are seeing, but all of these medications cross the placenta and so the baby is exposed. And there are a few big issues – one is the issue around cardiac defects in the first trimester.

These side effects are extremely rare, says Kim.

But recently, a jury awarded a family $2.5 million in a lawsuit that alleged Paxil, an anti-depressant, was responsible for a young boy’s birth defects, including two holes in his heart.

After consultations with her doctors, Anne Hildenbrandt opted to treat her severe depression with medications as well as therapy.

Hildenbrandt:
The benefits outweighed the risks so, and my son was born fine, healthy.
Scott: Were you scared though?
Hildenbrandt: I was more scared for myself with this depression, because there is depression in my family. Depression that was not treated, so I didn’t want to end up like that – I needed to take care of myself for my kids.

Deborah Kim agrees that babies benefit when mothers take care of their health. She says the rare cases where a baby is harmed by an anti-depressant get huge amounts of media coverage – but what’s far more common are cases where maternal depression has a detrimental effect on a fetus.

Kim: Depression itself during pregnancy is associated with poorer prenatal care, increased rates of substance abuse, pre-term birth.

Kim says intensive therapy without medication can work, but pregnant women rarely have the time for that. She is currently testing magnetic brain stimulation on pregnant women. This approach is FDA approved for severe depression, it’s safe for pregnant women, and preliminary results have been promising.

Many doctors find the lack of data when it comes to the risks of medications for pregnant women to be very frustrating. Paul Lyons is a professor of family care at Temple University.

Lyons: Fundamentally, we’re limited in the studies that we can do. We can’t do the studies were you expose on purpose pregnant women to increasing doses of medication to see what a safe level is. So we’ll never know for any medication with absolute certainty that it’s safe.

And that’s a problem for all medical issues – not just depression. Kerry, what are researchers doing to get more information?

Kerry: There are people collecting data. Pharmaceutical companies, academic labs, government labs, they are doing this through surveys called pregnancy registries.

Maiken: How long have they been around?

Kerry:
They’ve actually been around for decades. Philadelphia is the home-base for a registry that began almost 20 years ago. The focus of that one was on women who had had organ transplants.

Vincent Armenti is the head of the registry. He’s a professor of surgery at Thomas Jefferson University.

Armenti:
Patients who would have had successful transplants who had come to clinic were doing well, and then might have been in fact discouraged from going on to have children. Because of the concerns of the impact of the transplant on their pregnancy as well as the concern of the medications.

Grens: So despite the concern that the transplant or the medication could interfere with future pregnancies, were women still getting pregnant anyway?

Armenti: Well, it’s interesting. When you have kidney failure or liver failure, along with that is usually a fertility problem. So sometimes to the surprise of the patient they would have a successful transplant maybe not even realizing that fertility had returned. Or they would want to have children.

Armenti and his colleagues asked women to volunteer to give feedback about their health and the health of their children. Twenty years and 2,000 patients later, Armenti says they’ve been able to help women better understand the risks of certain drugs on their developing babies.

Armenti:
What we’ve learned is that successful pregnancies can occur in the transplant patient if the patient has stable transplant function. If they are rejection free. if they are compliant and have good obstetrical health.

He also learned that one particular drug was associated with birth defects, and the drug’s label has since changed to reflect that.

The Food and Drug Administration is taking new steps now to make pregnancy registries more commonplace. Most recently, the FDA required a registry as a condition for approving two drugs for sale. Karen Feibus is the medical team leader on the FDA’s maternal health team.

Feibus:
We thought, these medications are going to be needed by pregnant women, and we required the companies that are making these drugs to set up pregnancy registries after approval and that process is happening.

The FDA has also proposed overhauling current drug labeling rules regarding safety during pregnancy. One of the changes would be to include contact information if a registry exists.

Susan Roberts says that would go a long way to helping collect data. She’s a professor at the University of North Carolina and a consultant to Kendle, a company that conducts registries.

Roberts: One of the biggest challenges to enrolling a pregnancy registry is recruiting the patients. Often patients don’t know about them or they think it’s going to be a big hassle to be involved, which usually is not. It never is really, they’re very simple studies.

Armenti said the next step could be to require pregnancy registries for all drugs that women of child-bearing age are likely to take. The FDA is not considering that expansion, though.


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