On behalf of Smiley & Smiley, LLP posted in Defective Products on Friday, February 13, 2015.
In our last post, we began a discussion about drug safety in pregnancy. We noted that it is often difficult to tell which medications may affect fertility, pregnancy and lactation. In an effort to make medication-related safety matters clearer for pregnant and lactating women, the FDA will soon change its approach to categorizing medications and explaining potential health risks which may affect female patients in their childbearing years.
This recent effort by the Food and Drug Administration is a welcome one, as any efforts which help to educate patients in ways that allow them to make informed decisions about their health are welcome. However, this effort does not address the most arguably critical factor affecting pregnant and lactating women’s health and safety in regards to medication-related risks.
Too few studies are conducted with regards to medication safety as it pertains to pregnant and lactating women. We frequently write about medications that may be safe for certain patients and incredibly dangerous for others. Similarly, we write about how physician negligence related to starting or stopping any given course of treatment can affect patient health and safety. When the effects of taking or stopping any given medication is not adequately studied during pregnancy, neither patients nor physicians can make truly informed treatment decisions.
Certainly, if a pregnant or lactating woman suffers harmful effects as a result of taking a certain medication, that woman may be able to hold the medication’s manufacturer accountable for failure to adequately study the effects of the drug on pregnant women. However, it is ideal to conduct such studies in the first place so that pregnant women do not become victims of harmful effects, period.
Source: The Huffington Post, "Pregnant Women Must Be Studied Too," Society for Women's Health Research, Oct. 21, 2014
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