Safety

Patanase (olopatadine hydrochloride) nasal spray

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- June 2009

Epistaxis and Nasal Ulceration: In placebo (vehicle nasal spray)-controlled clinical trials of 2 weeks to 12 months duration, epistaxis and nasal ulcerations were reported.
Nasal Septal Perforation: Two placebo (vehicle nasal spray)-controlled long term (12 months) safety trials were conducted. In the first safety trial, patients were treated with an investigational formulation Patanase Nasal Spray containing povidone (not commercially marketed formulation) or a vehicle nasal spray containing povidone. Nasal septal perforations were reported in one patient treated with the investigational formulation of Patanase Nasal Spray and 2 patients treated with the vehicle nasal spray. In the second safety trial with Patanase Nasal Spray, which does not contain povidone, there were no reports of nasal septal perforation.
- Before starting Patanase Nasal Spray, conduct a nasal examination to ensure that patients are free of nasal disease other than allergic rhinitis. Per from nasal examinations periodically for signs of adverse effects on the nasal mucosa and consider stopping Patanase Nasal Spray if patients develop nasal ulcerations.

In the Patanase and vehicle nasal spray groups, 72% and 74% of patients, respectively, completed the trial. Overall, 7% and 5%, respectively, discontinued study participation due to an adverse event.
Depression or worsening of depression occurred in 9 patients treated with Patanase Nasal Spray and in 5 patients treated with vehicle nasal spray. Three patients, two of whom had pre-existing histories of depression, who received Patanase Nasal Spray were hospitalized for depression compared to none who received vehicle nasal spray.