Post-marketing safety of pentosan polysulfate sodium: a 21-year pharmacovigilance analysis of the FAERS database
Researchers analyzed 21 years of adverse event reports submitted to the FDA's Adverse Event Reporting System (FAERS) for pentosan polysulfate sodium, characterizing its post-marketing safety profile including reports of pigmentary maculopathy associated with long-term use — the retinal safety signal that has prompted updated monitoring guidance for patients on extended therapy.
This is a summary. The reporting is Frontiers in Medicine's, and the link below goes to the original article.