Pregnancy and Birth Defects
Very little is known about the effects of most medications on pregnant women and fetuses. That’s because pregnant women usually aren’t included in studies to determine how safe new medications are before they hit the market. In fact, the U.S. Food and Drug Administration (FDA) reports fewer than 10 percent of all medications that have been approved by the agency since 1980 have enough information to determine their risks for birth defects.
Boston dangerous drug lawyers at The Law Offices of Jeffrey S. Glassman know that drugs that may be hazardous to a baby if taken by the mother during pregnancy are known as “teragenic drugs.” While we recognize that birth defects can occur regardless of exposure to medication (the general rate is about 4 percent of all pregnancies), drug companies owe a duty to inform patients of possible risks associated with continued use of their product during pregnancy and lactation.
Consumer Reports has indicated use of medications during the first trimester has increased 60 percent in the last 30 years, with expectant mothers on average taking three to five different medications. In many cases, these drugs are an essential part of medical treatment. But as professors with the Boston University School of Public Health and Medicine cautioned, the lack of information on the safety of a drug doesn’t mean that it’s safe.
Although some medications are known to be harmful if taken during gestation and lactation, the risks of many others are unknown. Effects could depend on:
- The dosage of medication taken;
- The potency of the drug;
- Stage of fetal condition at the time of drug exposure;
- Other health conditions of the mother or child;
- Other medications taken by the mother.
In order to address growing concerns about labeling of medications consumed by expectant mothers – and prospective fathers – the FDA issued a final rule in December 2014 that is referred to as the, “ Pregnancy and Lactation Labeling Rule.” These changes went into effect in June 2015.
Dangerous Drugs During Pregnancy
While we may not be confident in our knowledge of which drugs are definitively safe for a pregnant woman and her fetus, we can be fairly certain about some of the medications we know are dangerous.
According to the Merck Manual, prescription drugs that have been shown to have teragenic qualities include:
- Some anti-depressants
- Asthma medications
- Thyroid drugs
- Blood-thinning medications, such as warfarin
This isn’t an exhaustive list, by any means.
Many women assume their doctor knows what is going to be safe for them during pregnancy, and will warn her if something could cause a problem. This isn’t always so. In fact, many doctors simply don’t known the long-term effects. And unfortunately, there are some drug manufacturers have actively worked to conceal the potential known dangers of the drug, putting scores of women and babies at risk for serious and permanent damage.
Categories for Drug Use in Pregnancy
One of the best tools a new mother has in determining the possible risks is the FDA’s drug use categories, which are A, B, C, D and X.
- Category A – Studies in pregnant women have indicated there is no increased risk of birth defects.
- Category B – Animal studies have indicated no evidence of harm to fetus, but there are no good quality studies in human women OR animal studies indicate an adverse effect, but studies of pregnant humans have not indicated a risk.
- Category C – Animal studies indicate a negative effect and there aren’t any good quality studies involving pregnant humans OR there have been no animal studies conducted and there aren’t any good quality studies of pregnant humans either.
- Category D – Studies of pregnant women have indicated there is a risk to unborn children BUT there could be some benefits that outweigh those risks.
- Category X – Studies in animals and/or pregnant humans have found proof of birth defects and the drug shouldn’t be used by women who are pregnant or may become pregnant.
Bear in mind, however, that pregnant women are almost always excluded from clinical studies. In 2007, Congress did grant the FDA authority to require drug makers to study effects of newly-approved medications on pregnant and nursing mothers. However, this is primarily done with pregnancy registries. That is, research institutions collect and maintain data on approved drugs that are taken by pregnant women and then study those effects. The Massachusetts General Hospital in Boston, for example, keeps a national registry of pregnant women who take epilepsy drugs.
Pregnancy and Lactation Labeling Final Rule
One of the newer developments on this front is the FDA’s Pregnancy and Lactation Labeling Rule, which updates Prescription Drug Labeling Sections 8.1 – 8.3, Use in Specific Populations.
Section 8.1, Pregnancy , will now include information for pregnancy, labor and delivery. It will include information for a pregnancy exposure registry, when one is available. This information was previously recommended, but not required.
Section 8.2, Labor and Delivery is now Section 8.2 Lactation, and includes nursing mothers. This subsection now provides information about uses of drugs while breastfeeding, including the amount of the drug that will make its way into breastmilk and the possible effects on the breastfed infant.
Section 8.3, Nursing Mothers, will now fall under the “lactation” section, and the new Section 8.3, Females and Males of Reproductive Potential will provide information, when necessary, regarding the need for pregnancy testing, recommendations about contraception and infertility information relating to the drug.
All drugs and biologic product submitted after June 30, 2015 have to use the new format. Those manufactured on or after June 30, 2001 are going to be phased in gradually.
Contact the Boston personal injury lawyers at The Law Offices of Jeffrey S. Glassman by calling (617) 367-2900.