Further investigation of this cluster revealed that 239 of these 324 cases (27 serious, 212
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non-serious) were reported into EV by a single marketing authorization holder over a 2-day period.
| Tip | Description | Why Important | Example |
|---|---|---|---|
| Verify Licenses | Confirm seller is licensed and certified | To avoid counterfeit products | Check pharmacy credentials |
| Read Customer Reviews | Review feedback from previous buyers | Ensures reliability and product quality | Look for verified buyers |
| Consult Healthcare Provider | Discuss with a doctor before purchase | To avoid contraindications and side effects | Schedule telemedicine check-in |
| Ensure Secure Payment | Use trusted payment options with encryption | Protects financial information | Credit card or trusted payment gateways |
No such cluster in 2011 was apparent in FAERS.
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Within the FAERS dataset, almost half of the retrieved, relevant ICSRs were suggestive for duplicates (i.e., ICSRs reporting the same country of origin, patient age and sex, suspect and concomitant drugs, ADRs and/or ADR onset dates, but received from different marketing authorization holders and with different Worldwide Unique Case Identification Numbers). Because full case information was not accessible through the FAERS Public Dashboard, definitive identification of case duplicates was not possible. Therefore, suspected duplicates were not categorically excluded from the FAERS dataset. However, probable duplicates were flagged and the effect of excluding these cases on reporting patterns was explored in the country-specific analyses. In the EVDAS Level 1 retrievals, exact patient age and ADR onset dates are not provided at all, thereby prohibiting reliable identification of potential duplicates.
WIPO Domain Name Decision D2005-0067 for europeanviagra.com (20 KB)
There was no indication of the presence of duplicates in Sanofi CHC’s global pharmacovigilance database or, from the limited information available, in the SMARS dataset. Number of ICSRs and reporting rates over time The mode of dispensing of the suspect drug is not reported in the outputs of any of the queried databases and could also not be reliably established from the trade name of the suspect PDE5i, which was missing in approximately 52.5% of the relevant ICSRs of tadalafil retrieved from Sanofi CHC’s company database. Unknown delays between dispense, administration, ADR onset and ADR reporting also prohibited reliable classification of ICSRs as “prescription cases” vs. “non-Rx/OTC cases” based on ADR onset date or report date. Therefore, the annual number of ICSRs over time (i.e., pre and post non-Rx/OTC switch) was displayed and assessed per country, acknowledging that ICSRs reported after the non-Rx/OTC switch date would comprise an unknown mix of ADRs occurring in prescription and non-prescription settings. 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.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Cialis Professional | 20mg | 20 Pills | 78.33€ 74.60€ | |
| Cialis Generic | 20mg | 20 Pills | 54.72€ 52.11€ | |
| Cialis Generic | 60mg | 270 + 10 Pills | 443.96€ 422.82€ | |
| Cialis Generic | 20mg | 120 + 8 Pills | 188.15€ 179.19€ | |
| Cialis Professional | 20mg | 180 + 4 Pills | 423.11€ 402.96€ | |
| Cialis Soft Tabs | 20mg | 20 + 2 Pills | 66.98€ 63.79€ | |
| Cialis Generic | 60mg | 180 + 10 Pills | 313.11€ 298.20€ | |
| Cialis Black | 80mg | 90 + 6 Pills | 207.88€ 197.98€ | |
| Cialis Soft Tabs | 20mg | 10 Pills | 39.03€ 37.17€ | |
| Cialis Black | 80mg | 10 Pills | 43.27€ 41.21€ | |
| Cialis Generic | 60mg | 30 + 2 Pills | 85.33€ 81.27€ | |
| Cialis Generic | 40mg | 10 Pills | 37.79€ 35.99€ | |
| Cialis Generic | 60mg | 60 + 4 Pills | 145.06€ 138.15€ | |
| Cialis Professional | 40mg | 120 + 4 Pills | 436.68€ 415.89€ | |
| Cialis Professional | 40mg | 20 Pills | 110.24€ 104.99€ |
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).
| 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 |
Table 3: Sildenafil, EVDAS: ICSRs by country and calendar year.
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To crudely adjust for changes in patient exposure over time, country-specific, annual RR (number of ICSRs per million sold tablets) were calculated for Poland, UK, Norway and Ireland for 2014-2024 on the basis is cialis generic of IQVIA sales data. For New Zealand, sales data were only available for 2016-2024 (Appendix 4). These analyses were stratified by case seriousness (EVDAS and Sanofi CHC’s global pharmacovigilance database only) and duplicate classification (probable duplicate yes/no; FAERS only). ADR summary tabulations on MedDRA PT level were produced from the downloaded case listings and evaluated for any noteworthy trends in the distribution of ADRs over time that could indicate towards potential changes in the characteristics of the ICSRs received before and after the non-Rx/OTC switch. As possible indicators of change of patient characteristics or drug utilization over time, ICSRs were evaluated for changes of average patient age (FAERS only) and for evidence of concomitant use of contraindicated drugs (EVDAS, FAERS, SMARS and Sanofi CHC’s pharmacovigilance database; Appendix 3).
Data collection
Sildenafil is a medication primarily used to treat erectile dysfunction and pulmonary arterial hypertension. Sildenafil works by relaxing the muscles in the blood vessels of the penis, allowing increased blood flow during sexual stimulation, leading to an erection. EudraVigilance: The query of EVDAS resulted in a total of 29,752 ICSRs concerning sildenafil with an EV Gateway receipt date ≥01 Jan 2010, of which 1,472 originated from one of the countries of interest. Of these, 392 cases, concerning children, females and/or treatment of PAH, were excluded. The remaining 1,080 cases were included in the analysis (Figure 1). Shaded cells indicate the year of switch of prescription status in the respective country.
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Case narratives or information on drug indications, mode of dispensing, ADR seriousness or outcomes, patient medical history or comorbidities or reporter causality assessments are not available. Reports from other countries are not included. SMARS is updated on a monthly basis. At the time of data retrieval for this analysis, data were current through 01 May 2024. Sanofi Consumer Healthcare’s (CHC) pharmacovigilance database holds full case information for all ICSRs reported for Sanofi medicinal products from worldwide sources.
WIPO Domain Name Decision D2003-0793 for viagra-propecia-xenical.com (24 KB)
ICSRs concerning sildenafil are not systematically collected in this database because Sanofi does not hold any marketing authorizations for sildenafil products. Currently, UK is the only country where Sanofi is marketing authorization holder and has launched a tadalafil product. In accordance with applicable regulatory requirements, ICSRs are entered into this database not only if they concern a Sanofi CHC product, but also if a Sanofi CHC product cannot be ruled out based on the reported information. Therefore, cases potentially concerning non-Sanofi CHC or not belonging to nonprescription tadalafil products might be stored in this database. The cut-off date for this database was 30 June, 2024. Because relevant variables for identification of case duplicates such as exact patient age or ADR onset date are
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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 roman cialis price cases (4%) from New Zealand. The proportion of consumer cases ranged from 14% for Norway to 74% for New Zealand. 487 cases (45%) were serious, including 43 (4%) fatal cases.
WIPO Domain Name Decision D2004-0733 for blueviagra.com, yellowviagra.com (24 KB)
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. Approximately one third of the cases (324/1,095 cases) were reported in 2011 alone. 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.
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FAERS: The query of FAERS resulted in a total of 47,238 ICSRs with FDA receipt
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For this analysis, data were retrieved with a cut-off date of 30 April, 2024. The FAERS is a database that contains ICSRs reporting suspected ADRs, medication errors and product quality complaints resulting in ADRs that were submitted to FDA by marketing authorization holders, healthcare professionals and consumers. The database includes serious and non-serious ICSRs reported from the US, whereas ICSRs from ex-US are generally captured only if they describe serious ADRs. Limited public access to FAERS is possible through the FAERS Public Dashboard, which allows for case level access to ADR reports. Case information includes originating country and receipt date of the report, patient age and sex, tradename, active ingredient and indication of the suspect medicinal product(s), concomitant drugs, MedDRA PTs of reported ADRs, as well as ADR onset date, seriousness and outcomes (Appendix 1).
WIPO Domain Name Decision D2005-0482 for great-cialis-viagra.biz (18 KB)
Case narratives or information on patient medical history, comorbidities, reporter causality assessments or the mode of dispensing are not available. The FAERS Public Dashboard is updated on a quarterly basis. At the time of data retrieval for this analysis, data were current through 31 March, 2024. SMARS is a publicly available query tool of New Zealand’s national pharmacovigilance database (Appendix 5). SMARS provides limited case level information on serious and non-serious ICSRs reported from New Zealand, including receipt date, patient age and sex, active ingredient of suspect and concomitant medicine(s) and the MedDRA PTs of reported ADRs (Appendix 1). date ≥01 Jan 2010, of which 1,414 originated from one of the countries of interest.
As seen in
Data retrievals and selection of relevant ICSRs FAERS, EVDAS and SMARS were queried for ICSRs where sildenafil was reported as a suspect or interacting drug and that had been initially entered into the respective database on or after 01 Jan, 2010. This date was chosen to allow for retrieval of ICSRs occurring with prescribed medicine that could serve as a baseline for comparison with ICSRs reported after the non-Rx/OTC switch. FAERS, EVDAS were also queried for ICSRs concerning tadalafil based on the same criteria. Sanofi CHC’s global pharmacovigilance cialis professional order database was queried for any ICSRs concerning tadalafil as suspect drug. Data from FAERS, EVDAS and Sanofi CHC’s global pharmacovigilance database were downloaded as Microsoft Excel® files (ICSR line listings).
Tadalafil: what you need to know
The ISCR listing resulting from the SMARS website query was also transferred into Excel®. Excel® was used to organize, classify, tabulate and visualize retrieved ICSRs. In line with the research questions, retrieved cases concerning sildenafil were included for further analysis only if they originated from Ireland, New Zealand, Norway, Poland or the UK. Cases concerning tadalafil were included for further analysis only if they originated from Poland or the UK. ICSRs concerning females, patients younger than 18 years of age, or describing use of sildenafil or tadalafil in patients with PAH (as defined in Appendix 2) were excluded from all analyses.