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Patanase (olopatadine hydrochloride) nasal spray
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- June 2009 and February 2012
WARNINGS AND PRECAUTIONS
Nasal Septal Perforation:
- In the third safety trial, one patient exposed to the 3.7 pH vehicle nasal spray (containing no povidone) reported a nasal septal perforation
The most clinically significant adverse reactions described in other sections of labeling include:
- Nasal Septal Perforation
- …In a third 3-arm 12-month, placebo (vehicle nasal spray)-controlled, safety trial conducted post approval, 1,026 patients 12 years of age and older with perennial allergic rhinitis were randomized to treatment with Patanase Nasal Spray (343 patients), a 3.7 pH vehicle nasal spray (341 patients), or a 7.0 pH vehicle nasal spray (342 patients)…The most frequently reported adverse event was epistaxis…Nasal septal perforation was reported for one patient treated with the 3.7 pH vehicle nasal spray. Nasal ulcerations occurred in 9% of patients treated with Patanase Nasal Spray, 8% of patients treated with 3.7 pH vehicle nasal spray, and 9% of patients treated with 7.0 pH vehicle nasal spray. Nasal ulceration resulted in the discontinuation of 1 patient treated with Patanase Nasal Spray. Hyposmia and anosmia were each reported by one patient treated with Patanase Nasal Spray. Neither somnolence nor weight loss was reported. Depression occurred in 3 patients treated with Patanase Nasal Spray, 2 patients treated with 3.7 pH vehicle nasal spray, and 3 patients treated with 7.0 pH vehicle nasal spray.
- There were no long-term clinical trials in children below 12 years of age.
- During the post approval use of Patanase Nasal Spray, the following adverse reactions have been identified… The most common adverse reactions reported include dizziness, dysgeusia, epistaxis, headache, nasal discomfort, oropharyngeal pain, and somnolence. Additionally, hyposmia and anosmia have been reported with the use of Patanase Nasal Spray.
WARNINGS AND PRECAUTIONS
Local Nasal Effects
- 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.
Clinical Trials Experience/Long-term (12-month) Safety Trials:
- 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.