Legal Status of Tadalafil (Cialis) in Ireland

EVDAS data are stratified by seriousness and FAERS data are stratified by duplicate classification.

In addition, potential changes in case characteristics over time are presented. For New Zealand, ICSRs retrieved from SMARS are additionally presented.

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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. 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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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. 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. 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.

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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. 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.

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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. 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. There was no indication of a significant increase in the number of reports following the non-Rx/OTC switch in 2014.

• Irish government websites offer guidance on buying medications like Cialis.
• Look for pharmacies with certifications such as IPGA or other Irish credentials.
• Cialis can be used safely when taken as prescribed and under supervision.
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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 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.

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Further information on data retrieved from SMARS is presented in below section (Figure 3). 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. 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.

• Patient support and resources are available from various organizations.
• The Irish Pharmacy Union (IPU) offers advice on safe medicine use.
• The HPRA website provides safety alerts and regulatory information.
• Men's health charities may offer information and support on ED.
• Your GP is a primary point of contact for ongoing health management.
• Do not hesitate to seek a second medical opinion if you have doubts.
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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.

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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). 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 cialis wholesale prices 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 date ≥01 Jan 2010, of which 1,414 originated from one of the countries of interest. 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. It is unclear why these cases were classified as serious in FAERS.

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.

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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). 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.

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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]. 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 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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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. Unknown delays between dispense, administration, ADR onset and ADR reporting also prohibited reliable classification of ICSRs as “prescription cases” vs.

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“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). 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). 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).

• Pharmacists in Ireland can advise on safe Cialis use and side effects.
• Availability of Cialis online can be affected by current health policies.
• Always disclose your full medical history before starting Cialis.
• Regular monitoring by a healthcare professional is recommended during treatment.