FDA Announces Safety Labeling Changes to Celexa

SrLCs include sexual dysfunction and special considerations for pediatric and geriatric populations.

The United States Food & Drug Administration (FDA) announced several Drug Safety-related Labeling Changes (SrLCs) to Celexa (citalopram hydrobromide; NDA-020822).

Celexa, a selective serotonin reuptake inhibitor (SSRI) used for treating depression, now includes new dosage recommendations and warnings for higher risk of adverse reactions in pediatric and geriatric populations. The new label also includes warnings for heightened risk of sexual dysfunction in both male and female patients, including decreased sex drive and delayed/absent ejaculation/orgasms.

These and more SrLCs have been approved by the FDA Center for Drug Evaluation and Research (CDER). For more SrLCs to Celexa and other drugs, visit the FDA’s SrLC website at https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=712.