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The annual ICSR reporting rates for Poland were notably lower than for the other countries included in this analysis.

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This observation is consistent with the traditionally low rate of spontaneous ADR reporting from Poland [5]. Case characteristics: The ADRs included in the ICSRs retrieved from EVDAS and FAERS, respectively.

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Table 7: EVDAS, Sildenafil, New Zealand: Number of relevant ICSRs retrieved, cialis online pharmacy canadian by seriousness. Shaded row indicates the year of switch of prescription status. Table 8: FAERS, Sildenafil, New Zealand: Number of relevant ICSRs retrieved, by seriousness. There was no indication of a trend towards a greater proportion of serious or fatal cases in either database after the switch to nonprescription status. A cluster of cases in FAERS (and SMARS) but not in EVDAS in 2023 mostly comprised reports of perceived drug ineffectiveness in the ED indication.

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It is unclear why these cases were classified as serious in FAERS. The number of relevant ICSRs retrieved from SMARS and the corresponding reporting rates are presented in Table 9. Because sales data were only available for 2016-2024, annual reporting rates could only be calculated for the post non-Rx/OTC switch period. These rates were consistently <1 per 1 million sold tablets until 2019 and <2 per 1 million sold tablets in 2020 and 2023. Table 9: Sildenafil, New Zealand: Number of relevant ICSRs retrieved from SMARS and corresponding reporting rates. A cluster of the ADRs ‘Death’ (N=7) in 2022 was identified.

ICSR review yellow cialis pill revealed 7 spontaneous cases each describing ‘Intentional product use issue’ and ‘Death’ and reported into EV/FAERS by one marketing authorization holder on the same day. The cases provide only minimal information, prohibiting further assessment. Otherwise, no noteworthy ADR clusters or trends over time were observed. Patient age was reported in 32 of the 54 cases retrieved for Poland from FAERS and ranged from 30 to 71 years (median, 64 years).

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The majority of the ICSRs were reported in the year generic brand cialis 2023 in which most frequently reported PT was Drug ineffective (n=5). No specific trend in adverse event reporting was observed. Case characteristics: The ADRs included in the ICSRs retrieved from EVDAS, FAERS and SMARS respectively. From the limited number of ICSRs reported, no noteworthy ADR clusters or trends over time were observed. Patient age, reported in 26 cases retrieved from SMARS, ranged from 39 to 81 years (median, 63.5 years).

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No time trend in patient age was apparent. No contraindicated medicines were reported as concomitant or cosuspect drugs in any of the ED cases from New Zealand retrieved from any of the three databases. Sildenafil is available as non-prescription medicine for treatment of ED in Poland since May, 2016. Number of ICSRs and reporting rates over time: The annual number of relevant cases and corresponding annual reporting rates for ICSRs retrieved from EVDAS (stratified by seriousness) and from FAERS (stratified by duplicate classification) for 2014 to 2024, are shown in Figures 4 and 5, respectively. The trend towards increasing annual ICSR numbers coincided with an almost 5-fold increase in exposure between 2014 and 2023 (full year data is not available for year 2024, hence data of 2023 was taken for comparison). No contraindicated medicines were reported as concomitant or cosuspect drugs in any of the ED cases from Poland retrieved from either database. Sildenafil is available as non-prescription medicine for treatment of ED in the UK since March, 2018. Number of ICSRs and reporting rates over time: Consistent with high exposure estimates for sildenafil in the UK as well as a traditionally high spontaneous ADR reporting rate, the majority of the ICSRs selected from EVDAS and FAERS (71.93% and 87.30%, respectively) were received from the UK (5).

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An increase in ICSR numbers over time was observed. This trend coincided with an approximately 75% increase in exposure between 2014 and 2022 and also needs to be seen against the backdrop of a general increase in spontaneous ADR reporting observed in Europe in recent years.

Annual exposure-adjusted ICSR reporting rates were consistently very low (<4 to 5 ICSRs per million sold tablets per year) but showed a transient increase for non-serious cases in 2018- 2019 and increase for serious cases in 2023 (Figure 6). In FAERs, this increase was found to predate the non-Rx/OTC switch and to be mostly explained by reporting of probable duplicates (Figure 7). There was no indication of a trend towards a greater proportion of fatal cases after the switch to non-prescription status in either database. Figure 6: EVDAS/Sildenafil/UK – Number of ICSRs and reporting rates, by seriousness. Figure 7: FAERS/Sildenafil/UK – Number of ICSRs and reporting rates, by duplicate classification.

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In the following subsections, trends of specific countries over time are further described. Countries are presented in chronological order of the switch of sildenafil to non-prescription status. In the following analyses, the annual number of ICSRs and county-specific annual reporting rate is presented for the cases retrieved from EVDAS and FAERS. EVDAS data are stratified by seriousness and FAERS data are stratified by duplicate classification. In addition, potential changes in case characteristics over time are presented.

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For New Zealand, ICSRs retrieved from SMARS are additionally presented. Since October, 2014 in New Zealand, pharmacists are supplying Sildenafil for the treatment of ED without prescription. Number of ICSRs and reporting rates over time: The annual number of relevant ICSRs retrieved from EVDAS and FAERS, stratified by seriousness, are shown in Tables 7 and 8, respectively. There was no indication of a significant increase in the number of reports following the non-Rx/OTC switch in 2014. Because most cases in EVDAS and FAERS were reported before 2016 whereas annual sales data were available only from 2016 onwards, calculation of meaningful reporting rates was not possible (Table 7 and 8). Possible clusters of individual ADRs (MedDRA PTs) after 2018 were consistently found to be artefacts, mostly due to probable case duplicates: A possible trend towards higher numbers of ADRs from the SOC “Nervous system disorders” was observed in both databases which was primarily attributed to a higher incidence of specific adverse events such as ‘Headache’, ‘Loss of consciousness’, ‘Syncope’, ‘Dizziness’ and ‘Subarachnoid haemorrhage’. Review of the corresponding cases in FAERS revealed that most of the cases reported in or after 2018 were duplicates (16 of the 29 cases reporting Headache were duplicates, 17 of the 23 cases reporting Syncope were duplicates, 16 of the 17 cases reporting Loss of consciousness were duplicates and 12 of the 21 cases reporting dizziness were duplicates).

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Consequently, exposure-adjusted reporting rates did not increase after the non-Rx/OTC switch in 2016. Increasing case numbers also need to be seen against the backdrop of a general increase in spontaneous ADR reporting observed in Europe. Moreover, for FAERS, more than half of the serious cases reported from Poland in recent years were determined to be probable case duplicates (Figures 4 and 5). Figure 4: EVDAS/Sildenafil/Poland – Number of ICSRs and reporting rates, by seriousness. Figure 5: FAERS/Sildenafil/Poland – Number of ICSRs and reporting rates, by duplicate classification. This high proportion of duplicate reports suggests that the actual number of unique adverse events may be considerably lower than initially indicated by the raw data. Two of the 8 cases reporting ‘Subarachnoid haemorrhage’ were identified as probable duplicates of a case initially reported in 2009 and further 5 cases were probable duplicates of a single case occurring in 2019. Since 2018, there has been a notable increase in Adverse Drug Reactions (ADRs) reported within the System Organ Class (SOC) of Vascular disorders from FAERS. This rise was attributed to reports of known undesirable effects, ‘Flushing’, ‘Orthostatic hypotension’, ‘Hypotension’ and ‘Hot flush’. In FAERS, 32 cases reported AE of Flushing, 15 cases reported orthostatic hypotension, 13 cases reported hypotension and 12 cases reported for hot flush. More than half of these above mentioned cases were probable duplicates. (22 out of 32 cases reporting Flushing were duplicates, 12 out of 15 cases reporting Orthostatic hypotension were duplicates, 9 out of 13 cases reporting Hypotension were duplicates and 9 out of 12 cases reporting Hot flush were duplicates).

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Table 4: Sildenafil, FAERS: ICSRs by reporter type and country. In the FAERS case set, a high proportion of probable case duplicates (i.e., ICSRs reporting the same country of origin, patient age, suspect and concomitant drugs, ADRs and ADR onset dates but received from different marketing authorization holders and with different Worldwide Unique Case Identification numbers) was apparent: overall, 391 of the 790 relevant cases (49%) were categorized as probable duplicates of other cases included in the case set. In some instances, more than 10 retrieved ICSRs were found to probably refer to the same case. This phenomenon started in 2014, likely as a consequence of the launch of generic sildenafil products, which led to the same ICSRs (e.g., those detected in the scientific literature) being reported multiple times by different marketing authorization holders. The distribution of the 790 cases across country and calendar year is shown in Table 6 (Table 5 and 6).

Data collection

Table 5: Sildenafil, FAERS: ICSRs by duplicate categorization and country. Table 6: Sildenafil, FAERS: ICSRs by country and calendar year. SMARS: The query of the New Zealand SMARS database revealed 43 cases, 37 of which were deemed relevant for this analysis. Further information on data retrieved from SMARS is presented in below section (Figure 3). Figure 3: Flowchart of ICSRs retrieved from SMARS. Review of a cluster of reports of ‘Cardiac arrest’ (14 ADRs in FAERS in 2021) revealed that 11 of these 14 cases are probable duplicates referring to the same patient.