Federal drug regulators have issued new rules on how the makers of pharmaceutical drugs and medical devices should inform consumers about the potential product side effects that could affect pregnancy, fertility and lactation. In the past, the U.S. Food and Drug Administration (FDA) relied on a letter category system of A, B, C, D and X to reflect information about the pregnancy risks associated with certain medications and biological products. However, in a new rule issued on December 3, the agency introduced a new system to replace the old one, which it says was overly simplistic. If you believe you have been adversely affected by side effects of a dangerous pharmaceutical drug or medical device, contact a skilled product liability lawyer today for legal help.
The FDA’s new system consists of three detailed subsections for medication and biological products, which the agency says will describe the risks associated with pregnancy, lactation, and male and female reproductive potential in real-world context. “Prescribing decisions during pregnancy and lactation are individualized and involve complex maternal, fetal and infant risk-benefit considerations,” said Sandra Kweder, deputy director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research, in a recent press release. “The new labeling rule provides for explanations, based on available information, about the potential benefits and risks for the mother, the fetus and the breastfeeding child.”
This new rule will affect the labels of pharmaceutical drugs and medical devices nationwide, and the FDA hopes that the use of a subsection providing information about the current state of side effect research will better inform pregnant and breastfeeding women about the risks associated with such products. Two classes of medications that have been of particular concern among expectant mothers in recent years, SSRI antidepressants and anticonvulsants, will now include a warning label providing detailed information about the potential risks to a developing fetus exposed to the controversial drugs during pregnancy.
A large number of SSRI (selective serotonin reuptake inhibitor) antidepressants, including Paxil, Zoloft and Prozac, have been tied to an increased risk of devastating birth defects among babies exposed to the medications during pregnancy, such as heart defects, cleft lip, cleft palate and persistent pulmonary hypertension of the newborn (PPHN). Similarly, exposure to anticonvulsant medications like Depakote in pregnancy has been identified as a risk factor for a host of serious birth defects among babies, including spina bifida, neural tube defects and heart malformations, as well as developmental delays and lower IQ scores.
With these new guidelines for highlighting pregnancy, lactation and fertility risks on drug labels, the FDA hopes to provide more detailed information about the real-world risks associated with certain medications, and to help consumers make better informed decisions about the drugs they take while pregnant or breastfeeding. If you used a potentially dangerous drug like Depakote or Paxil during pregnancy, and your child was born with a serious birth defect, our consumer advocates at the Consumer Justice Foundation can help. We are dedicated to protecting the rights of consumers harmed by dangerous drugs, and can help put you in touch with a knowledgeable attorney who has experience handling drug injury claims.