No noteworthy ADR clusters or trends over time were observed.
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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.
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(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). 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. Patient age was reported for 17 of the 22 cases retrieved
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from FAERS and ranged from 31 to 81 years (median, 63 years).
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No contraindicated medicines were reported
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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. 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. as concomitant or cosuspect drugs in
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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). 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.
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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. 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 cialis help with premature ejaculation 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. any of the ED cases from Norway retrieved from either database.
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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). Consequently, exposure-adjusted reporting rates did not increase after the non-Rx/OTC switch in 2016.
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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. 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. A cluster of the ADRs ‘Death’ (N=7) in 2022 was identified. ICSR review 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. Sildenafil is available as non-prescription medicine for
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treatment of ED in Ireland since January, 2021.
| Side Effect | Percentage of Users Reporting | Severity | Likelihood if Overused | Recommendations |
|---|---|---|---|---|
| Headache | 20% | Mild | Higher | Take with water |
| Muscle Pain | 10% | Mild to Moderate | Less likely | Monitor dosage |
| Flushing | 15% | Mild | Same | Avoid hot environments |
| Indigestion | 8% | Mild | Less likely | Take with food |
Number of ICSRs and reporting rates over time:
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The annual number of relevant cases and corresponding
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annual reporting rates for ICSRs retrieved from EVDAS, stratified by seriousness, are shown in Figure 10.
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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. It is unclear why these cases were classified as serious in FAERS.
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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. The majority of the ICSRs were reported in the year 2023 in which most frequently reported PT was Drug ineffective (n=5).
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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). No time trend in patient age was apparent. There was no increase in case numbers or reporting
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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. Figure 8: EVDAS/Sildenafil/Norway – Number of ICSRs 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. rates during the limited period since non-Rx switch in Ireland.
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