Is it Safe for my Baby?

Published on 03 February 2015

What does this mean for the more than 6 million annual pregnancies? Alicia Forinash, Pharm.D., FCCP, BCPS, BCACP, associate professor of pharmacy practice at St. Louis College of Pharmacy is one of a few obstetric pharmacists in the country. She practices at a high-risk OB-GYN clinic in St. Louis helping women manage both their pregnancy and serious health conditions like high blood pressure, diabetes, and asthma.

What do you think about the new labeling system?

I think these changes are going to be fabulous. Under the old system, many health care professionals would look at the medication’s category rating and say the patient couldn’t take it unless the medication was category A or B. Many medical conditions, especially chronic ones, still need to be treated during pregnancy. Those conditions often have more risk to the pregnancy and the baby if they are left untreated and uncontrolled compared to the risk the medications pose to the baby.

What are some of the limitations of the old grading system?

It had many faults and was overly simplified. For example, a medication received just one grade for the entire pregnancy. Some medications that are slightly risky in the first trimester are not associated with problems later in the pregnancy. That was never conveyed. Additionally, two categories commonly used for medications, categories B and C, have 2 definitions. This makes it hard to know if the pregnancy information is based on human or animal data. There was also a lack of information related to the dose of the medication or the rate of the birth defect compared to the background risk of pregnancy.

Are there any shortcomings in the new system?

I think it’s a little too early to determine since these new labels are not available yet, but both moms and health care providers will have better information. It’s still not the only place you can turn. You still need to have a conversation with your health care provider, both your OB/GYN and your pharmacist, about balancing risks.

What is your recommendation to moms-to-be?

It is important to have a conversation with your healthcare provider to understand the risk of the disease state versus the risk of the medicine. Everything in pregnancy is about balancing risk and potential of harm to both mother and baby. There is a lot of scary information about medication and it can be made very frightening depending on how the information is framed.

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