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Suggestions

Pharmacovigilance

Product Date Safety information Attachments
Jectin-12® (Cyanocobalamin)

Cyanocobalamin and the risk of medication error.

Xeljanz® (Tofacitinib)

Increased risk of pulmonary embolism and overall mortality with higher dose of XELJANZ (tofacitinib) for rheumatoid arthritis.

Genvoya ® (elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide)

Increased risk of treatment failure and increased risk of mother-to-child transmission of HIV infection due to lower exposure of elvitegravir and cobicistat during the second and third trimesters of pregnancy.

Dapagliflozin

Risk of Fournier’s gangrene (necrotising fasciitis of the perineum) with Sodium-glucose-Co-Transporter 2 inhibitors (SGLT2i).

Adenuric® (Febuxostat)

Febuxostat (adenuric®): Higher rate of cardiovascular death in gout patients with established cardiovascular disease.

Belimumab

Benlysta (Belimumab) and Risk of serious Depression and/ or Suicidal ideation or Behavior or self-injury.

Atezolizumab

TECENTRIQ® (atezolizumab): A New Important Identified Risk: Immune-related Myositis.

Canagliflozin

Risk of Fournier´s gangrene (necrotising fasciitis of the perineum) with Sodium-Glucose-Co-Transporter 2 inhibitors (SGLT2i).

Pembrolizumab

Keytruda (pembrolizumab): Restriction of indication for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy.

Empagliflozin

Direct Healthcare Professional Communication on the association of Sodium-Glucose-Co-Transporter 2 inhibitors (SGLT2i) with Risk of Fournier´s gangrene (necrotising fasciitis of the perineum).