In accordance with paragraph 8 of Section IV of the Procedure for Expert Evaluation, the applicant must amend the instructions for medical use of the medicinal product upon receipt of new data, including bringing the instructions for medical use into line with the approved instructions for medical use of the original (reference) medicinal product, and ensure that the information on the medicinal product corresponds to current scientific knowledge.
Sildenafil (sildenafil) (indication: pulmonary arterial hypertension) – EMEA/H/C/PSUSA/00002700/202105
Taking into account the report of the Pharmacovigilance Risk Assessment Committee (PRAC) on the assessment of periodic safety update reports (PSURs) for medicinal products containing sildenafil (sildenafil) (indication: pulmonary arterial hypertension), the scientific conclusions of the CHMP are as follows:
In view of the available data on the drug interaction between sildenafil and medicinal products containing sacubitril/valsartan, including cases from the literature, and in view of the plausible mechanism of action, the PRAC considers that a causal relationship between the concomitant use of sildenafil and medicinal products containing sacubitril/valsartan and increased hypotension has been established. The PRAC concluded that appropriate changes should be made to the instructions for medical use of medicinal products containing sildenafil.
CHMP agrees with the scientific conclusions drawn by PRAC.
Based on the scientific conclusions on sildenafil (sildenafil) (indication pulmonary arterial hypertension), the CHMP considers that the benefit/risk balance of medicinal products containing sildenafil (sildenafil) (indication pulmonary arterial hypertension) remains unchanged, subject to the proposed amendments to the instructions for medical use
Recommendations on amending registration materials based on the results of the CHMP meeting of 24 – 27 January 2022
Sildenafil (sildenafil) (indication: pulmonary arterial hypertension) – EMEA/H/C/PSUSA/00002700/202105
Based on the results of the CHMP meeting, it was recommended to amend the registration materials/instructions for medical use on the basis of the PRAC recommendations and the PSUR assessment report for medicinal products containing sildenafil (sildenafil) (indication: pulmonary arterial hypertension).
Update the section “Interaction with other medicinal products and other forms of interaction” of the instructions for medical use by adding a warning about the increased hypotension observed with the concomitant use of sildenafil (sildenafil) and medicinal products containing sacubitril/valsartan.
Changes to the safety information of medicinal products containing sildenafil based on the results of the PRAC meeting of 10 – 13 January 2022
EMA has published the minutes of the PRAC meeting of January 10 – 13, 2022. Following the meeting, a decision was made on the need to make safety-related changes to the registration materials/instructions for medical use of medicinal products containing sildenafil (sildenafil).
Sildenafil (sildenafil)1 – PSUSA/00002700/202105
Based on the evaluation of the PSUR, PRAC reviewed the benefit/risk balance of medicinal products containing sildenafil and made the following recommendations.
Summary of recommendations and conclusions
- Based on the analysis of safety and efficacy data, the benefit/risk balance of medicinal products containing sildenafil for the approved indications remains unchanged.
- Nevertheless, the instructions for medical use should be updated by including a warning about increased hypotension in patients concomitantly using sildenafil and medicinal products containing sacubitril/valsartan. Accordingly, the existing provisions of the instructions for medical use should be amended2.
PRAC considers that the warning about increased hypotension in patients concomitantly using sildenafil and medicinal products containing sacubitril/valsartan also applies to medicinal products containing sildenafil indicated for erectile dysfunction, and should be included in the instructions for medical use accordingly.
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1 Indication: pulmonary arterial hypertension
2 Update to the section “Interaction with other medicinal products and other forms of interaction” of the instructions for medical use. The risk assessment report and PRAC recommendation are forwarded to the CHMP for decision.
Changes to the safety information of medicinal products containing sildenafil based on the results of the meeting of the Coordination Group for Mutual Recognition and Decentralized Procedures – Human (CMDh) held on January 25 – 27, 2022
As part of the Periodic Safety Update Report Single Assessment (PSUSA) procedure for medicinal products containing sildenafil (indication: pulmonary arterial hypertension), the PRAC noted that sildenafil is also authorized as a medicinal product indicated for erectile dysfunction. The PRAC considers that the risk of enhanced hypotension with concomitant use of sildenafil and medicinal products containing sacubitril/valsartan should also be included in medicinal products containing sildenafil indicated for erectile dysfunction, since there are data from one pharmacokinetic/pharmacodynamic study (Hsiao et al.) in which 28 male patients with arterial hypertension received sildenafil in addition to sacubitril/valsartan.
List of medicinal products containing sildenafil (sildenafil) and authorized for medical use in Ukraine (according to the State Register of Medicinal Products as of 03.10.2023).
To analyze the published information, the applicant must use the original text available at the following links:
