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In these fatal ICSRs, majority of the ICSRs (N=39; 95.1%)

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reported unspecified cause of death (PT-Death), with no relevant information reported.

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Table 10: EVDAS, Tadalafil, Poland: Number of relevant ICSRs retrieved, by seriousness. Table 11: FAERS, Tadalafil, Poland: Number of relevant ICSRs retrieved, by seriousness. In view of the low total number of cases and the high number of probable duplicates, ICSR reporting rates were not calculated. The ADRs included in the ICSRs retrieved from EVDAS and FAERS respectively. The listings reflect the repetitive reporting in particular of a single literature report primarily describing the occurrence of back pain in a patient with depression that was reported together with a number of additional events including tachycardia, tachypnoea and various neuropsychiatric events. And among these 39 fatal cases, majority (N=25; 64.1%) of the

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cases were reported in elderly group patients (Table 12 and Figure 12).

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Table 12: Pattern of cases reported overtime from EVDAS in UK.

Figure 12: EVDAS/Tadalafil/United Kingdom – Number of ICSRs, by seriousness and reporting rate.

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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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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. The case describes a lifethreatening suspected drug-drug interaction with an alpha receptor agonist and a beta blocker, which are listed drug interactions where particular caution is advised. Further information on this case is not available. Of the other 3 ICSRs, one is a literature report where exposure to sildenafil predated the non-Rx/OTC switch and one is a published report from the Netherlands describing death primarily attributed to illicit use of 3-methylmethcathinone; both cases are thus unrelated to the non-Rx switch in the UK. In the remaining third article, radiological and clinical findings of HIV associated pneumonia and patient being a heavy smoker are risk factor for cardiac arrest leading to fatality. Other serious reported PTs were Drug ineffective (n=19), Headache (n=13), Chest pain (n=11) and Myocardial infarction (n=10).

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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.

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Figure 7: FAERS/Sildenafil/UK – Number of ICSRs and reporting rates, by duplicate classification. 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). 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. No specific trend was observed in the remaining serious events (less than 2% of the total events).

Number of ICSRs and reporting rates over time (FAERS): The number of

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Patient age was reported for 17 of the 22 cases retrieved from FAERS and ranged from 31 to 81 years (median, 63 years). No contraindicated medicines were reported as concomitant or cosuspect drugs in any of the ED cases from Norway retrieved from either database. Sildenafil is available as non-prescription medicine for treatment of ED in Ireland since January, 2021. 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, are shown in Figure 10. There was no increase in case numbers or reporting rates during the limited period since non-Rx switch in Ireland.

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Figure 10: EVDAS/Sildenafil/Ireland – Number of ICSRs and reporting rates, by seriousness. Of the 17 cases retrieved for Ireland from FAERS for Ireland (Table 6), 4 cases were classified as probable duplicates. In view of the low case numbers, ICSR reporting rates for cases retrieved from FAERS for Ireland were not calculated. Case characteristics: The ADRs included in the ICSRs retrieved from EVDAS and FAERS respectively. From the limited number of ICSRs reported in EVDAS and FAERS, no noteworthy ADR clusters or trends over time were observed. ICSRs reported overtime for tadalafil in UK is presented in Table 13. In FAERS data, increase in RR in 2023 could be possibly due to high number of duplicates.

In these ICSRs, the majority of the events reported were with PT Death (n=20) and Drug ineffective (n=6).

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Patient age was reported for 541 of the 770 cases retrieved from FAERS and ranged from 22 to 91 years (median, 59 years). No contraindicated medicines were reported as concomitant or cosuspect drugs in any of the ED cases from the UK retrieved from either database. Sildenafil is available as non-prescription medicine for treatment of ED in Norway since August, 2019. Number of ICSRs and reporting rates over time: ICSR numbers and reporting rates over time for cases retrieved from EVDAS and FAERS are shown in Figures 8 and 9, respectively. Based on small case numbers, a possible trend towards higher in case numbers in EVDAS is apparent; however, this trend started several years before the non-Rx switch in Norway and was mostly due to non-serious cases.

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Figure 8: EVDAS/Sildenafil/Norway – Number of ICSRs dapoxetine and cialis and reporting rates, by seriousness. Figure 9: FAERS/Sildenafil/Norway – Number of ICSRs and reporting rates, by duplicate classification. No fatal cases were retrieved for Norway from either database since non-Rx switch (August, 2019). Case characteristics: The ADRs included in the ICSRs retrieved from EVDAS and FAERS. No noteworthy ADR clusters or trends over time were observed. No specific trend was noted for the remaining PTs.

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Patient age was reported for 18 of the 20 cases retrieved from FAERS and ranged from 28 to 69 years (median, 59 years). No contraindicated medicines were reported as concomitant or cosuspect drugs in any of the ED cases from Ireland retrieved from either database. Tadalafil is available as OTC medicine for treatment of ED in Poland since March, 2022. The query of EVDAS for cases concerning daily cialis cost tadalafil resulted in a total of 13 946 ICSRs with an EV Gateway receipt date ≥ 01 Jan, 2010 of which 15 ICSRs originated from Poland (Figure 11). The query of FAERS yielded 27,569 ICSRs concerning tadalafil with FDA receipt date ≥ 01 Jan, 2010 of which 23 ICSRs originated from Poland.

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All cases retrieved from EVDAS and FAERS for Poland treated for ED or unknown indications and were included in the analysis. Figure 11: EVDAS, Tadalafil, Poland: Number of ICSRs and Reporting rate. Number of ICSRs and reporting rates over time: Almost all cases in both databases were reported in 2022. Case review in FAERS suggested that 17 of the 23 cases were probable duplicates, of which 13 probable duplicates created from a single literature report that was published in February 2022 (prior to tadalafil becoming available as non-prescription medicine). Thus, there was no increase in the number of reports after the tadalafil OTC switch in Poland (Tables 10 and 11). A total of 102 Tadalafil cases were reported in Sanofi CHC global company safety database.

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No other noteworthy ADR clusters or trends over time were observed. No contraindicated medicines were reported as concomitant or cosuspect drugs in any of the tadalafil cases from Poland retrieved from either database. Tadalafil is available as non-Rx medicine for treatment of ED in UK since June, 2023. Number of ICSRs and reporting rates over time (EVDAS): The number of ICSRs reported overtime for tadalafil in UK is presented in Table 12. The higher RR from 2023-2024 was observed in serious ICSRs, of which majority accounted for the fatal outcome (N=41). Of these 102 cases ,52 cases were pertaining to Cialis OTC cases which accounts for a total of 50.9% of the total tadalafil cases.