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28 No Clear Counterfactual The FDA and applicants would need to consider plausible counterfactuals

Fernandes DM, Oliveira CR, Guerguis S, Eisenberg R, Choi J, Kim M, Abdelhemid A, Agha R, Agarwal S, Aschner JL, Avner JR, Ballance C, Bock J, Bhavsar SM, Campbell M, Clouser KN, Gesner M, Goldman DL, Hammerschlag MR, Hymes S, Howard A, Jung HJ, Kohlhoff S, Kojaoghlanian T, Lewis R, Nachman S, Naganathan S, Paintsil E, Pall H, Sy S, Wadowski S, Zirinsky E, Cabana MD, Herold BC

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Zoloft has been associated with an increased risk of certain birth defects, such as persistent pulmonary hypertension of the newborn (PPHN), a severe lung condition