Disproportionality analysis of FAERS (2004-2024) identified elevated heart failure risks for hypoglycemic drugs (rosiglitazone, saxagliptin) and unflagged drugs like amiodarone and aliskiren.
Observational
Which medications are associated with an increased risk of drug-induced heart failure in the FAERS database?
This FAERS database analysis confirms known heart failure risks for certain hypoglycemic and pulmonary hypertension drugs while identifying potential new signals for drugs like amiodarone, aliskiren, and testosterone.
Heart failure (HF), the advanced stage of diverse cardiac conditions, poses a significant public health challenge. This study analyzes adverse event (AE) signals associated with HF within the FDA Adverse Event Reporting System (FAERS) database, offering critical insights to guide rational medication use in clinical settings. Adverse event reports (AERs) associated with HF in the FAERS database, spanning from the first quarter of 2004 to the fourth quarter of 2024, were analyzed. The potential HF risk of drugs was assessed using the disproportionality analysis, with findings juxtaposed against the American Heart Association (AHA) drug list. Drug-induced HF cases showed equivalent distribution between male and female, and high rates of rehospitalization and mortality. Prominent hypoglycemic drugs associated with HF included rosiglitazone, pioglitazone, and saxagliptin. Combination therapies, such as metformin/saxagliptin and metformin/rosiglitazone, also demonstrated elevated risks. In the context of pulmonary hypertension, drugs like macitentan, selexipag, and epoprostenol were particularly notable. Analysis against the AHA drug list confirmed stronger signal strength and frequency among Class A drugs, validating our results. Furthermore, drugs not flagged as positively signaling in the AHA registry, such as amiodarone, aliskiren, and testosterone, merit closer scrutiny due to their potential for adverse reactions. Our analysis of the FAERS database has identified medications associated with potential HF risks, providing valuable evidence to inform clinical decision-making and promote the safe use of medications.
Li et al. (Wed,) conducted a observational in Heart failure. Medications (e.g., rosiglitazone, pioglitazone, saxagliptin, macitentan) vs. Other drugs in FAERS database was evaluated on Drug-induced heart failure adverse event signals. Disproportionality analysis of FAERS (2004-2024) identified elevated heart failure risks for hypoglycemic drugs (rosiglitazone, saxagliptin) and unflagged drugs like amiodarone and aliskiren.