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However, FAERS has well-known limitations: Reports are spontaneous and incomplete Reporting stimulated by media attention and warnings No denominator (unknown number of exposed users) Thyroid cancer not subtype-adjudicated Confirmation bias (clinicians primed to connect drug and outcome) FAERS can answer: "Is this being reported more?" It cannot answer: "Does this drug cause thyroid cancer?" Appropriate Use of FAERS: FAERS findings are hypothesis-generating signals requiring controlled observational work—not evidence of causality
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Jensen EP, Poulsen SS, Kissow H, et al
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