Postmarketing safety of anaplastic lymphoma kinase (ALK) inhibitors: an analysis of the FDA Adverse Event Reporting System (FAERS)

ALK inhibitors differed in their safety profile reports. We found several significant safety signals that matched previously published case reports, including pulmonary arterial hypertension, rectal perforation, myasthenia gravis, and photosensitivity. These signals require further regulatory investigation to determine their significance and potentially update the product labels to inform patients and clinicians.