Navstel
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Navstel
SIDE EFFECTS
Clinical Studies Experience
Increased intraocular pressure was the most frequently reported adverse reaction which occurred in 12% of the 391 patients exposed to NAVSTEL® (balanced salt ophthalmic solution) Solution and 11% of the 431 patients exposed to BSS PLUS® Solution.
The following table presents the incidence of patients with IOP ≥ 25 mmHg. IOP lowering medication was not administered until after the first IOP assessment at hour 6 (anterior segment studies) or Day 1 (posterior segment study).
Table 1: Anterior Segment Studies
| Treatment | NAVSTEL® N=223 |
BSS PLUS® n=220 |
| IOP ≥ 25 mmHg | % | % |
| Hour 6 | 38 | 35 |
| Day1 | 17 | 15 |
| Day3 | 6 | 4 |
| Day7 | 0.5 | 0 |
| Posterior Segment Study | ||
| Treatment | NAVSTEL® N=168 |
BSS PLUS® n=176 |
| IOP ≥ 25 mmHg | % | % |
| Day1 | 7 | 5 |
| Day7 | 8 | 8 |
| Day14 | 10 | 4 |
| Day 30 | 4 | 4 |
Table 2 presents the most common adverse reactions reported with NAVSTEL® (balanced salt ophthalmic solution) and BSS PLUS.
Table 2
| Treatment | NAVSTEL® N=391 |
BSS PLUS® n=431 |
| Coded Adverse Reactions | % | % |
| Nervous system disorders | ||
| Headache | 3 | 3 |
| Eye disorders | ||
| Ocular Discomfort | 5 | 3 |
| Macular Edema | 4 | 4 |
| Conjunctival Hyperemia | 4 | 3 |
| Dry Eye | 3 | 5 |
| Iritis | 3 | 1 |
| Retinal Hemorrhage | 3 | 1 |
| Vision Blurred | 2 | 1 |
| Posterior Capsule Opacification | 2 | 3 |
In the posterior segment surgical study, cataract was reported in 11% of patients exposed to NAVSTEL® (balanced salt ophthalmic solution) , compared to 7% of patients exposed to BSS PLUS® .
Read the Navstel (balanced salt ophthalmic solution) Side Effects Center for a complete guide to possible side effects »
DRUG INTERACTIONS
No information provided.
Last reviewed on RxList: 9/3/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Navstel Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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