The FDA recently released a new system for labeling that would better alert women who are pregnant or breastfeeding that certain prescription drugs could be harmful. In the preamble to this rule, the agency also claims that this new system will preempt any claims brought by women who are injured by these products or who claim they were not adequately warned about the dangers of these products. It would be helpful to include examples of other instances where pregnant or lactating women sustained injuries caused by inadequate warnings on drugs, or examples where the FDA first said it was safe for pregnancy and later admitted that it was not.
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