"New Safety Information: Alecensa and Xalkori Linked to Acute Pancreatitis - What You Need to Know"

The FAERS Potential Signals of Serious Risks/New Safety Information listed Alecensa (alectinib) and Xalkori (crizotinib) with Acute pancreatitis as a potential signal on their October - December 2023 listing.

Analyzing the FAERS data up to 2024 Q1 for reports submitted with these drugs as primary suspect drug, the PRR for Pancreatitis acute (PT) is less than 2 when comparing the drugs within its ATC groups ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS, ANTINEOPLASTIC AGENTS, PROTEIN KINASE INHIBITORS and ANAPLASTIC LYMPHOMA KINASE (ALK) INHIBITORS.

ALECTINIB ATCs	PRR	MGPS	BCPNN	ROR	CHISQ
ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS	0.79172	0.79184	48.67538	0.79158	0.16442
ANTINEOPLASTIC AGENTS	0.56844	0.56868	46.57615	0.56793	0.98443
PROTEIN KINASE INHIBITORS	0.59352	0.59375	43.00782	0.59183	0.84054
ANAPLASTIC LYMPHOMA KINASE (ALK) INHIBITORS	0.74518	0.74533	32.66805	0.69422	0.3365

CRIZOTINIB ATCs	PRR	MGPS	BCPNN	ROR	CHISQ
ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS	1.22577	1.22557	51.21514	1.22622	0.37453
ANTINEOPLASTIC AGENTS	0.88007	0.88017	49.11591	0.87964	0.14756
PROTEIN KINASE INHIBITORS	0.9189	0.91897	45.54758	0.91788	0.06524
ANAPLASTIC LYMPHOMA KINASE (ALK) INHIBITORS	1.15372	1.15358	35.2078	1.30743	0.32505

Pancreatitis acute is included in Acute pancreatitis (SMQ) under the narrow scope category, and Drug reaction with eosinophilia and systemic symptoms syndrome (SMQ) under the broad scope category. There are other adverse events reported under the HLT: Acute and chronic pancreatitis for both drugs. Pancreatitis acute is included in the EMA IME list. Further analysis is required to confirm the potential signal.