Systemic adverse drug events to topical prostaglandin analogs for treating glaucoma: a retrospective focused pharmacovigilance study (2025)

BMC Ophthalmology volume24, Articlenumber:554 (2024) Cite this article

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Abstract

Background

Prostaglandin analogs are first-line treatments for open-angle glaucoma due to their proven efficacy in reducing intraocular pressure. Despite their topical administration, systemic adverse drug Events (ADEs) have been reported. This study investigates the systemic ADEs associated with topical prostaglandin analogs using the United States Food and Drug Administration (USFDA) Adverse Drug Event Reporting System (AERS) database.

Methods

The USFDA AERS database was queried for reports on prostaglandin analogs from March 2004 to March 2024 in this retrospective pharmacovigilance study. Data were deduplicated and analyzed using disproportionality analysis with both frequentist and Bayesian approaches. Reports on systemic ADEs where topical prostaglandin analogs were the primary suspect were included. Statistical analysis was performed using descriptive statistics and the chi-square test for categorical variables.

Results

A total of 30,853 reports were analyzed, predominantly involving latanoprost and bimatoprost, with most patients being elderly and female. In general, hypersensitivity reactions were the most common systemic adverse events reported with prostaglandin analogs. Varied systemic adverse events were observed within the class as latanoprost was linked to conditions like angina pectoris, atrial tachycardia and Meniere’s disease, bimatoprost to lentigo maligna melanoma, and tafluprost to labyrinthitis and skin discoloration. Notably, tafluprost had a significantly higher occurrence of death compared to other prostaglandin analogs, yet the causal relationship has not been established for this association due to unavailability of critical data on temporality and potential confounders including concomitant diseases/drugs and severity of the disease.

Conclusion

Prostaglandin analogs are associated with systemic ADEs, particularly in elderly and female patients. The most reported systemic adverse event was hypersensitivity reactions for the class and cardiac events for latanoprost. Tafluprost was observed with higher mortality statistically, yet causal relationship could not be established in the absence of details on the potential confounders. The findings emphasize the need for continuous monitoring of adverse reactions, and consideration of patient-specific factors when prescribing these medications.

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Introduction

Prostaglandin analogs are the first-line treatment for open-angle glaucoma due to their proven efficacy in reducing intraocular pressure (IOP) [1]. Prostaglandins, derived from arachidonic acid through the action of cyclooxygenase enzymes, have various physiological functions throughout the body [2]. Among the different prostaglandins, prostaglandin F2α is particularly important for glaucoma treatment as it relaxes the ciliary smooth muscles and remodels the extracellular matrix of the uveoscleral pathway, thereby facilitating the outflow of aqueous humor and reducing IOP [3].

Typically administered topically, prostaglandin analogs are effective in lowering IOP. While local adverse events are common, systemic adverse drug reactions (ADRs) are more frequently associated with other topical anti-glaucoma medications, such as beta-blockers and alpha-agonists [4, 5]. The physicochemical properties of prostaglandin analogs, including their lipophilicity and excellent permeability through the conjunctival and nasal mucosa, increase the risk of systemic absorption [6]. Despite this, the systemic ADRs associated with prostaglandin analogs are not well understood [7]. There have been a few case reports linking these drugs to upper respiratory tract inflammation and infections, as well as a preliminary review of adverse event databases suggesting a possible association with elevated blood pressure [8, 9].

The United States Food and Drug Administration (USFDA) Adverse Drug Event Reporting System (AERS) is a publicly accessible database of adverse events reported by healthcare professionals, consumers and drug manufacturers as part of a spontaneous reporting system [10]. This database is a valuable resource for identifying drug and device-related safety signals. Given the limited information on systemic adverse drug events (ADEs) related to prostaglandin analogs, we conducted this study to assess the USFDA AERS database for systemic ADEs associated with these drugs used in glaucoma treatment.

Methods

Data source

This study was conducted using a retrospective pharmacovigilance design. The USFDA AERS database was queried individually using the following prostaglandin analogs approved by USFDA (Table1) [11]. The data that was included in this study was obtained from the USFDA AERS pertaining to the spontaneously filed reports between March 2004 and March 2024, encompassing 81 quarterly reports. Given the scope of this study, which does not involve human interactions, the collection of personal identifiers, or any data beyond publicly available information, approval from the Institutional Ethics Committee was deemed unnecessary.

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Data processing

This study utilized individual case safety reports submitted via the spontaneous reporting system, with details of the electronic submission process available on the USFDA AERS website [12]. The data that was obtained with the search terms was checked for duplication. Deduplication of the reports where data pertaining to the same cases was eliminated as per the USFDA’s recommendations. The records were first sorted out using the Case _ ID for identifying the duplicate reports, following which the record with the highest individual safety report number was retained, and the previous records were discarded. The USFDA delegates the association of reported drugs to the adverse events into one of the following categories: primary suspect, secondary suspect, interacting, or concomitant. Only those reports with the adverse drug events associated with prostaglandin analogs as primary suspects were considered in this study. Similarly, only the non-proprietary names of topical prostaglandin analogs were considered. We obtained the following data each unique report: gender, year, adverse events, and outcomes. Reports for which missing data were there were excluded from the analysis for that specific variable. Only systemic adverse drug events were focused on in this study.

Data mining algorithms

Disproportionality analysis approach was used for identifying potential signals of systemic adverse events using the “case-non-case” approach that was based on the relative occurrence of adverse events amongst cases (those reported with the drug of interest) in relation to non-cases (those with all drugs other than the drug of interest) [13]. Open vigil 2.1 platform was used for analyzing the data. Signal detection was carried out using the frequentist and Bayesian approaches. The measures used in the frequentist approach included reporting odds ratio (ROR) and proportional reporting ratio (PRR) [14]. The ROR is represented with 95% confidence intervals (CI). A signal was considered to have been generated in the frequentist method only if all the following criteria were met: at least three unique case reports should exist, PRR ≥ 2, and Chi-square (χ2) ≥ 4 [15]. For Bayesian approach, we adhered to the Bayesian confidence propagation neural network (BCPNN) and multi-item gamma Poisson shrinker (MGPS) methods for estimating the signal detection measures. The Bayesian measures provided details on the information component (IC) where potential signals were detected when the lower 95% CI limit of IC025 exceeded zero. Similarly, in the empirical Bayes gamma mixture (EBGM), signals were considered when the lower 95% CI limit of EBGM05 exceeded 2 [15]. We employed Bayesian analyses only for adverse drug events with positive signals from frequentist measures. The reported outcomes were categorized into one of the following: death, life-threatening events, and hospitalization (initial or prolonged).

Statistical analysis

Descriptive statistics were used for representing demographic characteristics. Proportion (%) was used for representing the categorical variables. Chi-square (χ2) test was used for estimating the statistical significance of the distributions of categorical variables. P-values of  0.05 were considered statistically significant. We used SPSS (IBM Corp. released 2020. IBM SPSS Statistics for Windows, Version 27.0. Armonk, NY: IBM Corp.) for carrying out statistical analysis.

Results

Search results

A total of 30,853 reports related to the drugs of interest were obtained (Fig.1). Most reports pertained to the use of latanoprost, followed by bimatoprost. A summary of the demographic characteristics of the reported patients is listed in Table2. Most patients, except those using bimatoprost, were elderly and predominantly female.

Study flow diagram

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Full size table

Total adverse drug events reported with Prostaglandin Analogs

The complete list of adverse drug events (ADEs), including local site reactions, is available in the Electronic Supplementary Tables 15 for latanoprost, bimatoprost, travoprost, tafluprost, and latanoprostene bunod, respectively. Among all reported ADEs (including local and systemic), treatment failure and ocular irritation were most common with latanoprost; treatment failure and ocular hyperemia with bimatoprost, travoprost, and latanoprostene bunod; and ocular hyperemia and irritation with tafluprost.

Systemic adverse drug events reported with Latanoprost

A summary of systemic ADEs reported with latanoprost as the primary drug suspect is presented in Table3. The most common systemic ADEs identified by frequentist methods with latanoprost were hypersensitivity reactions, followed by hypoacusis. The signals identified with latanoprost by both frequentist and Bayesian measures included atrial tachycardia, hearing impairment, hypoacusis, labyrinthitis, Meniere’s disease, vestibular neuronitis, hypersensitivity reactions (including excipients), general problems (e.g., drug name confusion, expired drug administration, incorrect dose and storage, product issues including container and seal), decreased body height, renal cell carcinoma, dementia, missed abortion, late-onset asthma, genital erythema, pharyngeal disorder, postnasal drip, abnormal hair growth, myocardial infarction, and temporal arteritis.

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Systemic adverse drug events reported with Bimatoprost

A summary of systemic ADEs reported with bimatoprost is listed in Table4. The most common systemic ADEs identified by frequentist methods with bimatoprost were hypersensitivity reactions. Signals detected by both frequentist and Bayesian measures included reduced fat tissue, allergic reactions (including preservatives), erroneous technique, dose and site of drug administration, lentigo maligna melanoma, migraine with aura, product issues (including container seal), abnormal hair growth, skin irritation, wrinkling and tightness, and ephelides.

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Systemic adverse drug events reported with Travoprost

A summary of systemic ADEs reported with travoprost is listed in Table5. Hypersensitivity reactions were the most common systemic ADEs identified by frequentist methods. Signals detected by both frequentist and Bayesian measures included deafness, labyrinthitis, worsening of concomitant disease, hypersensitivity reactions (including preservatives), product issues, diabetes mellitus, dementia of Alzheimer’s type, tension headache, and skin hyperpigmentation.

Full size table

Systemic adverse drug events reported with Tafluprost

A summary of systemic ADEs reported with tafluprost can be found in Table6. Death, followed by headache, were the most common systemic ADEs identified by frequentist methods for tafluprost. Signals detected by both frequentist and Bayesian measures included seasonal allergy, coronavirus infections, product issues (including incorrect storage), upper airway cough, skin discoloration, and tightness.

Full size table

Systemic adverse drug events reported with Latanoprostene Bunod

A summary of systemic ADEs with latanoprostene bunod is listed in Table7. Product issues, followed by hypersensitivity reactions, were the most common systemic ADEs reported with latanoprostene bunod by frequentist methods. Signals detected by both frequentist and Bayesian measures included hypersensitivity reactions, product issues (including container), and inability to afford the medications.

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Comparison of outcomes within the prostaglandin analogs

A comparison of key outcomes among the individual prostaglandin analogs is depicted in Fig.2. A statistically significant increase in the occurrence of death was observed with tafluprost compared to the other analogs (χ2: 294.46; df: 8; p < 0.05). However, this should be interpreted with great caution as causal relationships could not be established due to constraints of data availability on temporality, dechallenge, rechallenge, and unavailability of data on concomitant diseases/drugs.

Comparison of reported outcomes (causality not established) between the prostaglandin analogs

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Discussion

Statement of key findings

In the study, 30,853 reports on drugs of interest were analyzed, with most reports focusing on latanoprost, followed by bimatoprost. Elderly and female patients were predominant in these reports. In general, hypersensitivity reactions were the most common systemic adverse events reported with prostaglandin analogs. Varied systemic adverse events were observed within the class as latanoprost was linked to conditions like atrial tachycardia and Meniere’s disease, bimatoprost to lentigo maligna melanoma, and tafluprost to labyrinthitis and skin discoloration. Notably, tafluprost had a significantly higher occurrence of death compared to other prostaglandin analogs, yet the causal relationship has not been established for this association.

Comparison with existing literature

Hypersensitivity reactions were commonly observed with all the prostaglandin analogs in this study. These reactions were also reported to compounds other than the active drugs within the formulations, such as excipients and preservatives. Common preservatives used with latanoprost include benzalkonium chloride (as a solubilizer), sodium chloride (as a tonicity agent), sodium dihydrogen phosphate monohydrate (as a buffer), disodium phosphate (as a buffer), hydrochloric acid (to adjust pH), and sodium hydroxide (to adjust pH) [16]. Similar preservatives and excipients are used in other prostaglandin analogs. Although excipients were previously considered inactive, recent observations have shown several adverse drug reactions, including hypersensitivity reactions and death [17]. A recent study demonstrated that preservative-free latanoprost preparation significantly improved tolerability, adherence, and efficacy compared to the preparation with preservatives [18]. Prostaglandin F2α has also been shown to increase bronchial muscle hyperreactivity to allergens and shift the histamine dose-response curve in humans to the left, suggesting an enhanced response [19]. Therefore, it is prudent to carefully consider administering prostaglandin analogs to patients with a history of allergic reactions or bronchial asthma.

Cardiac adverse events, such as tachyarrhythmias (including atrial tachycardia and extrasystoles), were reported with prostaglandin analogs, particularly latanoprost and travoprost. Prostaglandin analogs used for treating glaucoma are mainly F2α mimics, and physiologically, prostaglandin F2α acts as a vasoconstrictor [20]. This could potentially explain the observed increase in blood pressure in a previous study [9]. The vasoconstrictive properties of topical prostaglandin analogs could also contribute to the occurrence of myocardial infarction, especially in elderly patients and those with high-risk factors [21]. In this study, signals associated with myocardial infarction were observed with latanoprost. A recent case series reported incidence of vasospastic angina that never occurred after discontinuing latanoprost eye drops [22]. Similarly, another series of five cases also reported chest tightness suggestive of angina with topical latanoprost that subsided following drug withdrawal [21]. Arrhythmias and myocardial infarction are common causes of sudden cardiac death [23]. All the prostaglandin analogs, particularly tafluprost, were associated with mortality in this study. While it can be hypothesized, the extent of contribution of cardiac adverse drug reactions to the mortality associated with prostaglandin analogs remains unknown. However, patients with known cardiac problems should be monitored carefully when using prostaglandin analogs or be advised to use alternative anti-glaucoma drugs. Further a systematic review and meta-analysis of randomized clinical trials revealed an increased risk of local adverse events with travoprost compared to latanoprost [24]. However, considering the lack of data related to systemic adverse events, that systematic review did not evaluate the association of various systemic adverse events with topical prostaglandin analogs.

The number of patients shifting from prostaglandin analogs to other classes due to poor tolerance or adverse effects is unknown. A recent study revealed that patients generally exhibited poor adherence to prostaglandin analogs, with only 50.1% adhering to latanoprost, 48.8% to travoprost, and 43% to bimatoprost over 24 months [25]. Future clinical studies should aim to evaluate the impact of systemic adverse events on the continuation rates of prostaglandin analogs.

Strengths and limitations

This study has several strengths, including its comprehensive analysis of 30,853 reports from the USFDA AERS database, which provides a robust dataset for identifying adverse drug reactions associated with prostaglandin analogs. The use of both frequentist and Bayesian approaches for signal detection enhances the reliability of the findings by cross-validating results through different statistical methods. Additionally, the detailed categorization of systemic and local adverse reactions and the demographic analysis of the patient population provide valuable insights into the safety profile of these drugs, especially in elderly and female patients who are predominant users.

However, there are notable weaknesses. The study’s reliance on spontaneous reporting data, which may be subject to underreporting or reporting bias, limits the generalizability of the findings. The exclusion of reports with missing data might also lead to an incomplete representation of adverse reactions. Despite following the recommended procedures for deduplication and including reports with unique identification numbers, residual duplicates may persist.Additionally, the inability to establish causality due to the observational nature of the data and the potential for confounding factors are significant limitations. This should be considered when interpreting the association of mortality risk with prostaglandin analogs, particularly with tafluprost. The study could benefit from a comparative analysis with other glaucoma treatments to contextualize the safety profile of prostaglandin analogs. Finally, the lack of data on patients who switched from prostaglandin analogs to other treatments due to adverse effects or poor tolerance limits the understanding of long-term adherence and safety.

Conclusion

This study analyzed 30,853 reports from the USFDA AERS database, revealing that prostaglandin analogs, particularly latanoprost and bimatoprost, were associated with systemic adverse events particularly hypersensitivity reactions and cardiac events. Tafluprost was observed with higher mortality statistically, yet causal relationship could not be established due to unavailability of critical data on temporality and potential confounders including concomitant diseases/drugs and severity of the disease. These findings highlight the need for vigilant monitoring of adverse reactions, especially in patients with pre-existing conditions. While effective for reducing intraocular pressure, careful consideration of patient-specific factors is essential when prescribing these medications. Future research should investigate long-term safety and adherence to improve patient outcomes.

A total of 28,655,483 reports were present in the USFDA AERS database out of which 30,853 unique reports exist for the prostaglandin analogs.

This stacked bar chart depicts the occurrence of key outcomes within topical prostaglandin analogs. Relatively more deaths were reported with tafluprost compared to other prostaglandin analogs from this hypothesis-generating exploratory study analyzing the reported adverse events by spontaneous reporting system. The reported data is not confirmatory as causality could not be established due to unavailability of data related to assessment of temporal relationship, dechallenge, rechallenge, and concomitant diseases/drugs.

Data availability

The data is available in the USFDA AERS web-portal that can be accessed as follows: https://fis.fda.gov/sense/app/95239e26-e0be-42d9-a960-9a5f7f1c25ee/sheet/7a47a261-d58b-4203-a8aa-6d3021737452/state/analysis.

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  1. Department of Pharmacology & Therapeutics, College of Medicine & Health Sciences, Arabian Gulf University, Manama, Kingdom of Bahrain

    Kannan Sridharan

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KS: Conceived the idea, collected data, carried out data analysis and wrote the manuscript.

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Correspondence to Kannan Sridharan.

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Systemic adverse drug events to topical prostaglandin analogs for treating glaucoma: a retrospective focused pharmacovigilance study (3)

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Sridharan, K. Systemic adverse drug events to topical prostaglandin analogs for treating glaucoma: a retrospective focused pharmacovigilance study. BMC Ophthalmol 24, 554 (2024). https://doi.org/10.1186/s12886-024-03823-w

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Keywords

  • Latanoprost
  • Bimatoprost
  • Travoprost
  • Tafluprost
  • Latanoprostene bunod
Systemic adverse drug events to topical prostaglandin analogs for treating glaucoma: a retrospective focused pharmacovigilance study (2025)
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