Table 13

Postmarking Surveillance VIA Adverse Event Reporting System (FDA)

 
AERS Cipro 11/30/97-10/31/02

3942 rpts

391 adrs

10%
AERS Levaquin 11/1/97-11/4/2003

5276 rpts

197 adrs

3.7%
AERS Floxin 11/1/1997-10/31/2002

1919 rpts

201 adrs

10.5%

ADR

Cipro

Levaquin

Floxin
visual disturbances

53

54

42
blurred vision

49

20

15
conjunctivitis (pink eye infection)

42

5

11
eye pain

26

12

4
diplopia (double vision)

22

11

1
eyelid edema

22

2
irritation of the eyes

15

3

7
corneal erosion

15

2
Blindness

23

5

8
visual field defects

11

6
swelling of the eyes

6
rolling of the eyes

6
Infections

6

1

6
transient blindness

6
Redness

5

2

1
corneal lesions

5
color blindness

5

2
optic papillitis (optic nerve)

4

5
optic neuritis retrobulbar (optic nerve)

4
optic nerve damage

3

3

2
retinal hemorrhage

3

2
retinal detachment

3

2
dilated pupils

3

2

1
eyelid disorders

3

2

2
dry eyes

3

4
eye hemorrhage

3

2
eye injury

2

1
eye burns

2
corneal oedema

2

3
corneal disorders

2

2

3
Cataracts

2

5
retinal vasculitis

2

1
retinal degeneration

2

1
retinal artery thrombosis

2
reading difficulties

2

4
optic neuropathy

2
optic atrophy

2

2

1
Ophthalmoplegia (eye muscle)

2

1
keratitis interstitial (cornea blood ves)

2

8
night blindness

1
detached descemets membrane

1
corneal ulcer

1

2
corneal scars

1
corneal abrasions

1
congentive eye disorder (birth defect)

1

2
Glaucoma

1

1

1
retinal disorder

1

1
retinal artery spasms

1
virtuous disorder

1

1
virtuous detachment

1
decrease visual activity

1

15
tunnel vision

1
Myopia

1
cataracts bilateral

1
eye oedema

1

2
eye movement disorder

1

5
eye disorders

8
macular degeneration

2
corneal opacities

1

7
Floaters

1

2
eyelid ptosis (drooping)

1
eyelid purititis

1
optic neuropathy

1
ocular hyperemia (red eye)

1
corneal deposits

1

1
reduced vision

15
optic neuritis (optic nerve inflammation)

14
abnormal vision

14
corneal perforation

13
corneal infiltrates (deposits of cells)

4
optic disk blurred

2
ocular hypertension

3
corneal epithemen defects

2
Inflammation

1
Discharge

1
keratitis conjunctivitis

1
burning sensation

1
retinopathy hypersensitive

1
lens disorder

1

In addition the literature reveals numerous reports of vision loss, some of which are irreversible following a course of therapy involving these agents (2.3). In some cases such reactions manifested upon ingestion of just ONE dose (3). Diminished eyesight, decreased vision, blurred vision (loss of visual acuity – sharpness of vision), blind spots (scotomas), floaters, retinal detachment, etc., are a significant threat to ones quality of life and ones vision.