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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
publication
Title:
Anaphylactic response to topical fluorescein 2% eye drops: a case report
Author:
Humma Shahid, John F Salmon
Year:
2010
Bibliographic source:
Journal of Medical Case Reports 4:27

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: As mentioned below
Principles of method if other than guideline:
Skin irritation test was conducted for chemical Sodium Fluorescein in human.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: Solid
Details on test material:
- Name of test material (as cited in study report): Sodium Fluorescein
- Molecular formula : C20H10O5.2Na
- Molecular weight ):376.28 g/mol
- Substance type: Organic
- Physical state: Solid

Test animals / tissue source

Species:
human
Strain:
other: Not applicable
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
Source: Oxford Eye Hospital
Age at study initiation:51 years
Weight at study initiation: Not mentioned
Fasting period before study: Not mentioned
Housing: Not mentioned
Diet (e.g. ad libitum): Not mentioned
Water (e.g. ad libitum): Not mentioned
Acclimation period: Not mentioned

Test system

Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
fluorescein 2% eye drops (Bausch and Lomb Minims®)
Duration of treatment / exposure:
30 seconds
Observation period (in vivo):
48 hour
Number of animals or in vitro replicates:
1 female
Details on study design:
A case of a 51-year-old woman who developed an anaphylactic reaction when she was administered fluorescein sodium 2% eye drops after cataract surgery is reported. This was the second time she had been exposed to fluorescein. She had brittle asthma and a history of anaphylaxis following exposure to a variety of drug and food allergens. She was successfully resuscitated and recovered completely over a period of two days

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
other: one person
Time point:
other: 30 seconds
Remarks on result:
other: Non irritating

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
A case of a 51-year-old woman who developed an anaphylactic reaction when she was administered fluorescein sodium 2% eye drops after cataract surgery is reported. This was the second time she had been exposed to fluorescein. She had brittle asthma and a history of anaphylaxis following exposure to a variety of drug and food allergens. She was successfully resuscitated and recovered completely over a period of two days.
This is a rare case of anaphylaxis caused after topical application of fluorescein in the eye.
Executive summary:

Almost all patients with ocular problems are exposed to fluorescein in topical form, during routine ocular examination. A case of a 51-year-old woman who developed an anaphylactic reaction when she was administered fluorescein sodium 2% eye drops after cataract surgery is reported.

 

A 51-year-old English woman attended the Oxford Eye Hospital for a postoperative check-up two weeks after uneventful phacoemulsification cataract surgery that was performed under topical anaesthesia. As part of the ophthalmic examination, fluorescein 2% eye drops (Bausch and Lomb Minims®) were administered topically into her operated eye in order to check the corneal wound integrity and measure the intraocular pressure. No other eye drops were instilled into her eye during her outpatient visit. Within 30 seconds of topical fluorescein administration, she developed acute dyspnoea, wheezing and tachycardia. Well-versed with the symptoms of the onset of anaphylaxis, she administered 0.6 mg intramuscular adrenaline from her auto-injector (EpiPen®). Venous access was obtained and the patient was given intravenous chlorpheniramine and oral prednisolone. Despite a good initial response, she deteriorated acutely within 30 minutes, with tongue swelling, airway obstruction, and subsequent loss of consciousness. Following appropriate resuscitation, she was transferred for further observation to the intensive care unit. She was discharged from our hospital after 48 hours.

 

This case illustrates how the administration of a seemingly benign fluorescein 2% eye drop can have serious consequences in a susceptible patient. The absence of an anaphylactic reaction when topical fluorescein is used for the first time does not preclude a life-threatening reaction from its subsequent administration in the same patient.