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Further 153 cases (14%) were from Norway, 76 cases (7%) from Poland, 45 cases (4%) from Ireland and 43 cases (4%) from New Zealand.

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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.

Tadalafil makes hard easy

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. 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.

WIPO Domain Name Decision D2004-0794 for cialis-viagra.info, cialisapcalis.com (26 KB)

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. 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.

WIPO Domain Name Decision D2013-0056 for overthecounterviagra.com (12 KB)

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. 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 of IQVIA sales data. For New Zealand, sales data were only available for 2016-2024 (Appendix 4). 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.

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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. ICSRs concerning sildenafil are not systematically collected in this database cialis vidalista 60mg 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.

WIPO Domain Name Decision D2005-0482 for great-cialis-viagra.biz (18 KB)

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. 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.

WIPO Domain Name Decision D2014-1030 for cialisoverthecounter.com (11 KB)

FAERS, EVDAS were also queried for ICSRs concerning tadalafil based on the same criteria. Sanofi CHC’s global pharmacovigilance 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). 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. The distribution of the 1,080 included cases by country and calendar year is shown in Table 3.

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This query provides case level outputs of the ICSR receipt date, patient demographics (age group and sex), tradename, active ingredient, indication, treatment duration, dose and route of administration of suspect and interacting medicinal product(s), concomitant drugs, as well as Medical Dictionary for Regulatory Activities (MedDRA) Preferred Terms (PT), seriousness and outcome of the reported ADRs (Appendix 1). Country of reporting is not displayed in Level 1 retrievals but can generally be inferred from the Worldwide Unique Case Identification number. Case narratives or information on patient medical history, comorbidities, reporter causality assessments or the mode of dispensing of the suspect drug (prescription or non-prescription/OTC) are not available. 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.

Deprivation and prescribing patterns

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). 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.

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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). 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. 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.

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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 buy cialis daily uk use of contraindicated drugs (EVDAS, FAERS, SMARS and Sanofi CHC’s pharmacovigilance database; Appendix 3). 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. 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.

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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). 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].