, 2025-05-01 12:00:00
TOPLINE:
An analysis of data from the US Food and Drug Administration Adverse Event Reporting System (FAERS) database revealed differences in patterns of ocular events associated with oral and injectable formulations of semaglutide, with injectable formulations linked to a higher frequency of retinal complications.
METHODOLOGY:
- The FDA has approved semaglutide as both a subcutaneous injection for treating type 2 diabetes and obesity and as a tablet for treating type 2 diabetes, prompting researchers to investigate the differences in the risk for ocular events between these formulations.
- Researchers extracted data from the FAERS database from 2004 through 2024, focusing on adverse drug events linked to use of semaglutide, and categorized the data by mode of administration of semaglutide.
- The study also examined factors such as sex, age, and time to the onset of adverse drug events.
TAKEAWAY:
- Researchers examined 1733 reports of ocular adverse drug events, comprising 1541 and 192 cases related to injectable forms and oral tablets, respectively; more than 50% of adverse drug events associated with both formulations were classified as nonserious.
- Time-to-onset analysis found most adverse events occurred within the first month of administration; however, the median time to the onset of adverse drug events associated with the oral formulation was 3.5 days, half of that observed for injectable forms (7 days).
- Women were more likely than men to report an adverse drug event, regardless of the formulation (62.72% vs 33.47%). Ocular events were more common in patients aged 45-64 years.
- The frequency of blurred vision and visual impairment was relatively high with both formulations of semaglutide; adverse drug events related to the retina were more common with subcutaneous injections than with the oral formulation.
IN PRACTICE:
“It is advisable that patients be closely monitored for symptoms such as blurred vision and visual impairment during the first month of treatment, especially concerning retinopathy linked to subcutaneous injections,” the researcher wrote.
SOURCE:
The study was led by Tao Zhao, of Nanfang Hospital and Southern Medical University in Guangzhou, China. It was published online on April 28, 2025, in BMC Ophthalmology.
LIMITATIONS:
The FAERS database is a spontaneous reporting system, which may have affected the quality and quantity of analyzed information. The analysis did not account for the effect of potential confounding factors such as drug interactions, previous health conditions, and use of multiple medications.
DISCLOSURES:
The study received support from the Guangzhou Baiyun District Dean’s Fund Project and Guangzhou Health Science and Technology Project. The authors declared no conflicts of interests.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.