BfArM - Federal Institute for Drugs and Medical Devices

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Direct Healthcare Professional Communication (DHPC) on Trisenox® (arsenic trioxide): risk of medication errors due to the introduction of a 2 mg/ml vial replacing the 1 mg/ml glass vial PDF, 239KB, File is accessible Date: 31. March 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: arsenic trioxide

The company Teva B.B. informs in coordination with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) that the Trisenox® (arsenic trioxide) 1 mg/ml 10 ml ampoule (contains 10 mg arsenic …

Direct oral anticoagulants (apixaban, dabigatran etexilate, rivaroxaban): no application changes required Date: 30. March 2020 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: apixaban | dabigatran etexilate | rivaroxaban

Following a review of the results of a European study with real-world drug-related data from use, no change in the use criteria of the direct oral anticoagulants Eliquis® (apixaban), Pradaxa® (dabigatran etexilate), and Xarelto® (rivaroxaban) …

Xeljanz® (tofacitinib): increased risk of venous thromboembolic events and of serious and fatal infections Date: 23. March 2020 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: tofacitinib

With the publication of the European Commission's decision, the risk assessment procedure in accordance with Article 20 of Regulation (EC) No. 726/2004 for Xeljanz® was completed.

Direct Healthcare Professional Communication (DHPC) on ulipristal acetate 5 mg for uterine fibroids: not to be used during ongoing review of liver injury risk PDF, 255KB, File is accessible Date: 23. March 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ulipristal acetate

Gedeon Richter Pharma GmbH in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) informs that Ulipristal acetate 5 mg is temporarily withdrawn from the market during the ongoing …

Direct Healthcare Professional Communication (DHPC) on Xeljanz® (Tofacitinib): increased risk of venous thromboembolic events and increased risk of serious and fatal infections PDF, 337KB, File is accessible Date: 20. March 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: tofacitinib

Pfizer, in coordination with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM), informs that a dose-dependent increased risk of serious venous thromboembolic events has been observed in …

DHPCs (Rote-Hand-Briefe) and Information Letters Date: 19. March 2020 Topics: Arzneimittelsicherheit Pharmakovigilanz Type: Article

Here you will find Direct Healthcare Professional Communications - DHPCs (so-called "Rote-Hand-Briefe") and Information Letters sent out by pharmaceutical companies informing healthcare professionals about newly identified major drug-associated risks …

Calcitonin: restricted use Date: 19. March 2020 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: Calcitonin

With regard to the intranasal route of administration for the osteoporosis indication, suspension of the marketing authorisations has been extended until 1 April 2020.

Direct Healthcare Professional Communication (DHPC) on Cytotec® (misoprostol): risks associated with an off-label use for birth initiation PDF, 235KB, File is accessible Date: 16. March 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Misoprostol

The German Federal Institute for Drugs and Medical Devices (BfArM) informs that there are numerous new reports of severe side effects when using Cytotec® outside the approved indication. The drug Cytotec® is not approved for birth initiation.

Expert Advisory Committee for Pharmacy-Only Issues Date: 06. March 2020 Topics: Arzneimittelsicherheit Pharmakovigilanz Type: Article

Meetings of the Expert Advisory Committee for Pharmacy-Only Issues (in accordance with section 53 German Medicines Act) take place as and when required.

Routine sessions pursuant to Section 63 German Medicines Act (AMG) Date: 06. March 2020 Topics: Arzneimittelsicherheit Pharmakovigilanz Type: Article

Routine sessions pursuant to Section 63 AMG take place at the BfArM at least twice a year, where graduated plan stakeholders (Stufenplanbeteiligte) exchange information about current problems of pharmaceutical safety.