Synarel (nafarelin acetate) Nasal Solution 2mg/mL

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) 

 

January 2012

Summary View

ADVERSE REACTIONS [Labeling for endometriosis]

Post-marketing 

Central/peripheral nervous adverse events: 

• Convulsion

Hepatic adverse events: 

• Rarely reported serious liver injury

ADVERSE REACTIONS [Labeling for central precocious puberty]

Post-marketing

Central/peripheral nervous adverse events: 

• Convulsion 

 

 

January 2011 

Summary View

 

ADVERSE REACTIONS

Postmarketing

• Cardiovascular adverse events: Cases of serious venous and arterial thromboembolism have been reported, including deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke, and transient ischemic attack. Although a temporal relationship was reported in some cases, most cases were confounded by risk factors or concomitant medication use. It is unknown if there is a causal association between the use of GnRH analogs and these events.