Important Arterial thromboembolic events identified trial tumours (benign and malign) disorders Depression Effects on hereditary angioedema Important potential Breast cancer risk Cervical dysplasia/cancer Decreased bone density in adolescents Weight increase Unrecognised pregnancies and the consequences of delayed pregnancy detection Detrimental effects on Crohn’s disease and ulcerative [NB: add ‘colitis’] Important missing Return to fertility information Use in women under 18 years of age Long-term safety RMP reviewer comment Notwithstanding to the evaluation of the non-clinical and clinical aspects of the Safety Specification, the summary of safety concerns is considered incomplete in the context of this application. From review of the advice presented in the PI: mellitus with vascular involvement’ is listed as a Contraindication, with ‘Diabetes Precautions also highlighting potential risks in this population. mellitus with ‘Diabetes vascular involvement’ should be included as an important potential risk to better monitor this population in future reporting. or a history thereof if associated with severe hypertriglyceridemia’ is ‘Pancreatitis listed as a Contraindication, with Precautions also highlighting this risk. ‘Pancreatitis or a history thereof if associated with severe hypertriglyceridemia’ should be included as an important potential risk. are Precautions relating to hypertension: If, during the use of a COC in hypertension, constantly elevated blood pressure values or a significant increase in blood pressure do not respond adequately to antihypertensive treatment, the COC must be withdrawn. or non-responsive hypertension’ should be ‘Pre-existing included as an important potential risk. of migraine with neurological symptoms’ is listed as a Contraindication. As ‘History this particular identified safety concern is shared across oral contraceptives, it is acceptable for this to not be included in the Summary.
Important identified Arterial thromboembolic events tumours (benign and malign) disorders Depression Effects on hereditary angioedema Important potential risk Breast cancer Cervical dysplasia/cancer Decreased bone density in adolescents Weight increase Unrecognised pregnancies and the consequences of delayed pregnancy detection Detrimental effects on Crohn’s disease and ulcerative [NB: add ‘colitis’] Important missing information Return to fertility Use in women under 18 years of age Long-term safety RMP reviewer comment Notwithstanding to the evaluation of the non-clinical and clinical aspects of the Safety Specification, the summary of safety concerns is considered incomplete in the context of this application. From review of the advice presented in the PI: ‘Diabetes mellitus with vascular involvement’ is listed as a Contraindication, with Precautions also highlighting potential risks in this population. ‘Diabetes mellitus with vascular involvement’ should be included as an important potential risk to better monitor this population in future reporting. ‘Pancreatitis or a history thereof if associated with severe hypertriglyceridemia’ is listed as a Contraindication, with Precautions also highlighting this risk. ‘Pancreatitis or a history thereof if associated with severe hypertriglyceridemia’ should be included as an important potential risk. are Precautions relating to hypertension: If, during the use of a COC in hypertension, constantly elevated blood pressure values or a significant increase in blood pressure do not respond adequately to antihypertensive treatment, the COC must be withdrawn. ‘Pre-existing or non-responsive hypertension’ should be included as an important potential risk. ‘History of migraine with neurological symptoms’ is listed as a Contraindication. As this particular identified safety concern is shared across oral contraceptives, it is acceptable for this to not be included in the Summary. trial