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FDA Takes Action to Provide More Information Regarding Safety of Prescription Drugs for Pregnant Women

Time and time again we see the same thing-a complete lack of information regarding prescription drug safety for pregnant women and their fetuses. And when this information is not provided, women find themselves either harmed themselves or dealing with harm done to their children that sometimes is not recognized until birth or even after. Fortunately, it appears that the Food and Drug Administration (FDA) is finally taking steps to provide expectant mothers with more desperately needed information so they can make the right choices for their family regarding their health care. The changes will also help breastfeeding mothers.

FDA Changed How Pharmaceutical Companies Present Medication Risks During Pregnancy The New York Times reports that the FDA changed how pharmaceutical companies will present the risks of taking medications during pregnancy and breast-feeding. The system up to now was created in the 1970s and is vague and ultimately not terribly useful. A key problem is that most drugs were classified in the category that meant “animal studies have shown potential risks to the fetus, but … no adequate studies exist for humans.” In other words, most drugs were categorized as “we don’t know the risk” and the guess work was completely pushed off onto the expectant mother.

What the New Rule Does

The new rule goes into effect this upcoming June. According to the FDA, the rule replaces the old system with a system that includes “three detailed subsections that describe risks within the real-world context of caring for pregnant women who may need medication.” The warnings documentation will now include three subsections for “Pregnancy,” “Lactation,” and “Females and Males of Reproductive Potential.” These subsections will be required to include a detailed summary of the risks of using the drug during pregnancy and breast-feeding including a discussion of the data supporting the summary. The manufacturers will have to state whether there is a registry that collects and maintains data on how pregnant women are affected by the drug.

How Many Will Be Affected?

While one might assume that pregnant women usually do not take many pharmaceuticals, that is actually not the case. According to the New York Times’ report, more than six million pregnancies occur each year in the United States, and women typically take between three and five prescription drugs over the course of their pregnancies.

Not a Complete Solution

There is still an unfortunate hole in the system. The new rule will not actually require drug companies to do tests to determine the effect of their drugs on pregnant or breast-feeding women and their children. So the drug companies can still just get away with not doing the studies, leaving expectant and new mothers along with their physicians to make uninformed guesses about the best course of action. Just as failures to require testing of drugs on other portions of the population has lead to horrible consequences, this failure could have disastrous consequences. But requiring the companies to provide the information that does exist may be a good first step, so long as it does not ultimately lead to even fewer safety tests being performed.

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