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Metipranolol-induced adverse reactions: I. The rechallenge study
T Akingbehin1, J R Villada, T Walley
1Department of Ophthalmology, Southport and Formby District General Hospital.
Eye (London, England)
|January 1, 1992
Summary
Metipranolol (Glauline) eye drops caused severe ocular inflammation and increased intraocular pressure in patients. This drug has now been withdrawn from clinical use in the UK due to these adverse reactions.
Area of Science:
- Ophthalmology
- Pharmacovigilance
- Drug Safety
Background:
- Adverse drug reactions (ADRs) mimicking natural diseases pose diagnostic challenges.
- A previous study identified 29 patients with ocular inflammation and elevated intraocular pressure (IOP) potentially linked to metipranolol (Glauline).
Purpose of the Study:
- To definitively establish a causal link between metipranolol and specific ocular adverse effects.
- To confirm previously suspected adverse drug reactions associated with metipranolol.
Main Methods:
- A double-blind rechallenge trial involving 7 patients from the initial cohort.
- Patients received either metipranolol 0.3% or timolol maleate 0.5%.
Main Results:
- All 7 metipranolol-treated eyes developed adverse reactions within 14 days.
- Metipranolol was conclusively proven to cause granulomatous anterior uveitis, blepharoconjunctivitis, and elevated IOP.
- These adverse effects were previously unreported for ophthalmic topical beta-blockers.
Conclusions:
- Metipranolol (Glauline) is definitively linked to causing granulomatous anterior uveitis, blepharoconjunctivitis, and elevated IOP.
- These findings led to the withdrawal of all metipranolol preparations from clinical use in the UK.
- Highlights the importance of rigorous drug safety monitoring and rechallenge studies for identifying novel ADRs.