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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Approximately one third of the cases (324/1,095 cases) were reported in 2011 alone. Further investigation of this cluster revealed that 239 of these 324 cases (27 serious, 212 non-serious) were reported into EV by a single marketing authorization holder over a 2-day period. No such cluster in 2011 was apparent in FAERS. A small subset of the serious cases could also be identified in FAERS, where they all had event onset dates and/or FDA receipt dates in 2009-2010. Together, these observations suggest that the case cluster seen in EVDAS for 2011 is due to delayed reporting of a batch of cases from earlier years (Table 3).
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Table 3: Sildenafil, EVDAS: ICSRs by country and calendar year. Shaded cells indicate the year of switch of prescription status in the respective country. Because relevant variables for identification of case duplicates such as exact patient age or ADR onset date are not available in the EVDAS Level 1 retrievals, reliable identification of duplicate ICSRs was not possible within this dataset. ICSR review did however reveal case clusters suggestive for possible duplicates. FAERS: The query of FAERS resulted in a total of 47,238 ICSRs with FDA receipt date ≥01 Jan 2010, of which 1,414 originated from one of the countries of interest. 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.
- Lack of regulation can lead to variable potency and impurities in OTC tadalafil.
- Illegal sales can contribute to drug resistance or adverse health reactions.
- UK law emphasizes the importance of validated prescriptions for PDE5 inhibitors.
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These rates were consistently <1 per 1 million sold tablets until 2019 and <2 per 1 million sold tablets in 2020 and 2023.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Cialis Generic | 40mg | 90 + 6 Pills | 171.35€ 163.19€ | |
| Cialis Generic | 5mg | 60 + 4 Pills | 86.02€ 81.92€ | |
| Cialis Generic | 20mg | 360 + 10 Pills | 427.34€ 406.99€ | |
| Cialis Generic | 60mg | 120 + 8 Pills | 240.18€ 228.74€ | |
| Cialis Generic | 10mg | 10 Pills | 31.41€ 29.91€ | |
| Tadalista Super Active | 20mg | 20 + 4 Pills | 92.35€ 87.95€ | |
| Tadalista Super Active | 20mg | 270 + 30 Pills | 661.49€ 629.99€ | |
| Cialis Generic | 20mg | 270 + 10 Pills | 335.21€ 319.25€ | |
| Cialis Generic | 60mg | 20 Pills | 65.61€ 62.49€ | |
| Cialis Generic | 2.5mg | 270 + 10 Pills | 199.64€ 190.13€ | |
| Tadalista Super Active | 20mg | 30 + 6 Pills | 128.09€ 121.99€ | |
| Cialis Generic | 60mg | 90 + 6 Pills | 196.67€ 187.30€ | |
| Cialis Generic | 2.5mg | 90 + 6 Pills | 112.43€ 107.08€ |
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). No specific trend in adverse event reporting was observed.
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In addition, potential changes in case characteristics over time are presented. 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.
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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). Table 10mg tadalafil 7: EVDAS, Sildenafil, New Zealand: Number of relevant ICSRs retrieved, 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. 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).
| Misconception | Reality | Source |
|---|---|---|
| OTC Tadalafil is completely safe | Not entirely, side effects and interactions possible | MHRA, NHS |
| Only prescribed meds work | OTC can be effective if used responsibly | Medical advice |
| It can cure all ED causes | It alleviates symptoms, not cures underlying causes | Urology guidelines |
| It’s addictive | No evidence of physical dependence | Clinical studies |
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.
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The distribution of the 790 cases across country and calendar year is shown in Table 6 (Table 5 and 6). 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).
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Figure 3: Flowchart of ICSRs retrieved from SMARS. 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. 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).
| Retailer Name | Website URL | Customer Ratings | Price for 10mg tablets | Shipping Cost | Payment Methods |
|---|---|---|---|---|---|
| UKPharmaciesOnline | ukpharmaciesonline.co.uk | 4.5/5 | £12 | Free over £50 | Credit Card, PayPal |
| MedsExpress | medsexpress.co.uk | 4.2/5 | £9 | £2.99 | Credit Card, Bitcoin |
| DiscountPharma | discountpharma.co.uk | 4.0/5 | £8 | £1.99 | Credit Card, Bank Transfer |
Consequently, exposure-adjusted reporting rates did not increase after the non-Rx/OTC switch in 2016.
- Tadalafil's legal status depends on UK drug classification laws.
- OTC availability outside the UK may not be valid or safe in the UK.
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- High-quality tadalafil requires proper medical dosing and monitoring.
- Using unprescribed tadalafil can interfere with other medications or health conditions.
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 rise of online "supermarket" sites claiming OTC tadalafil is unregulated.
- UK authorities regularly crack down on illegal online drug sales.
- Pharmacists cannot dispense tadalafil without a valid prescription in the UK.
- Always verify credentials and licensing of online pharmacies.
- Avoid purchasing tadalafil from unverified sources to ensure safety.
The annual ICSR reporting rates for Poland were notably lower than for the other countries included in this analysis. 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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Of these, 624 cases, concerning children, females and/or treatment of PAH, were excluded. The remaining 790 cases were included in the analysis (Figure 2). Figure 2: Flowchart of ICSRs retrieved from FAERS. Of the 790 relevant cases, 686 (87%) were from the UK, 54 (7%) from Poland, 20 (3%) from Norway, 18 (2%) from New Zealand and 12 (2%) from Ireland. Consistent with the regulatory reporting requirements for foreign ICSRs into FAERS, overall case numbers per country were lower than in EVDAS and all cases but one (99.9%) were serious.
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The proportion of consumer cases ranged from 15% for Norway to 72% for New Zealand (Table 4). 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. 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. 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.
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The remaining 1,080 cases were included in the analysis (Figure 1). Figure 1: Flowchart of ICSRs retrieved from EVDAS. Consistent with high exposure estimates for sildenafil in the UK (Section 3.1.2.3) as well as traditionally high spontaneous ADR reporting rates in the UK, 763 (71%) of the 1,080 cases included in the analysis were reported from the UK [5]. Further 153 cases (14%) were from Norway, 76 cases (7%) from Poland, 45 cases (4%) from Ireland and 43 cases (4%) from New Zealand. The proportion of consumer cases ranged from 14% for Norway to 74% for New Zealand.
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487 cases (45%) were serious, including 43 (4%) fatal cases. The proportion of serious cases ranged from 16% for Norway to 52% for UK (Table 1 and 2). Table 1: Sildenafil/EVDAS: ICSRs by reporter type and country. Table 2: Sildenafil/EVDAS: ICSRs by seriousness and country. The distribution of the 1,080 included cases by country and calendar year is shown in Table 3. 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). 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.