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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.
Abstract:
Previously unreported adverse drug reactions can be difficult to detect and it may be even more difficult to establish a cause and effect relationship, particularly if the adverse reactions mimic naturally occurring disease. In a previous paper we reported 29 patients with granulomatous anterior uveitis, blepharoconjunctivitis, periorbital dermatitis, marginal keratitis and elevation in intraocular pressure (IOP), suspected to be caused by metipranolol (Glauline). With the approval of the District Ethics Committee 7 of those patients were rechallenged with metipranolol 0.3% compared to timolol maleate 0.5% in a double blind trial. The 7 metipranolol treated eyes developed an adverse reaction within 14 days. Metipranolol (Glauline) has been conclusively proven to cause granulomatous anterior uveitis, blepharoconjunctivitis and elevation in IOP, adverse effects never previously reported with any of the ophthalmic topical beta-blockers. The multidose preparations of metipranolol (Glauline) in all three strengths 0.1%, 0.3% and 0.6% and the single dose minim preparation of metipranolol 0.6% have now been withdrawn from clinical use in the United Kingdom.
Insights
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 This drug has now been withdrawn from clinical use in the UK due to these adverse reactions.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.