BfArM - Federal Institute for Drugs and Medical Devices

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Direct Healthcare Professional Communication (DHPC) on ▼Xeljanz (tofacitinib): increased risk of major adverse cardiovascular events and malignancies (excluding NMSC) with use of tofacitinib relative to TNF— alpha inhibitors PDF, 322KB, File is accessible Date: 25. March 2021 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: tofacitinib

Preliminary results from a clinical trial suggest an increased risk of serious cardiovascular events and malignancies (other than NMSC) with the use of tofacitinib compared to TNF-alpha inhibitors.

Direct Healthcare Professional Communication (DHPC) on Cabazitaxel Accord® 20 mg/ml concentrate for solution for infusion: risk of medication errors and confusion with Jevtana® (60 mg/1.5 ml) concentrate and solvent for solution for infusion PDF, 244KB, File is accessible Date: 09. March 2021 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: cabazitaxel

Accord Healthcare S.L.U., Spain, in coordination with the European Medicines Agency (EMA) and the German Federal Institute for Drugs and Medical Devices (BfArM), would like to inform about the risk for the occurrence of medication errors due …

Direct Healthcare Professional Communication (DHPC) on Lojuxta® (Lomitapide): liver function monitoring and contraindication during pregnancy PDF, 271KB, File is accessible Date: 17. February 2021 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: lomitapide

The company Amryt Pharmaceuticals DAC, in coordination with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM), reminds that lomitapide is contraindicated in patients with impaired liver …

Information Letter on Mitem 20 mg Powder for Solution for Injection or Infusion or Powder and Solvent for Solution for Intravesical Use: Design change of saline bags PDF, 423KB, File is accessible Date: 17. February 2021 Topics: Pharmakovigilanz Aktuelles Type: Direct Healthcare Professional Communication

Active substance: Mitomycin

The company Substipharm informs about a change in the design of sodium chloride bags.

Direct Healthcare Professional Communication (DHPC) on Miltefosin (Impavido® 10 mg/50 mg Capsules): new warning about ocular changes, including keratitis PDF, 638KB, File is accessible Date: 05. February 2021 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: miltefosine

The company Paesel und Lorei GmbH & Co. KG informs in coordination with the Federal Institute for Drugs and Medical Devices (BfArM) that in a few case reports complications of the eye (including keratitis) occurred under treatment with …

Direct Healthcare Professional Communication (DHPC) on Alkindi® (hydrocortisone granules in capsules for opening): risk of acute adrenal insufficiency when switching from crushed or compounded oral hydrocortisone formulations PDF, 798KB, File is accessible Date: 04. February 2021 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: hydrocortisone

Diurnal Europe B.V. informs about the report of an adrenal crisis in an infant who was switched from soluble hydrocortisone tablets to Alkindi®.

Direct Healthcare Professional Communication (DHPC) on ulipristal acetate 5 mg: indications for uterine fibroids restricted due to concerns of severe liver injury PDF, 681KB, File is accessible Date: 01. February 2021 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ulipristal acetate

The marketing authorization holders, in coordination with the European Medicines Agency (EMA) and the German Federal Institute for Drugs and Medical Devices (BfArM), inform about new restrictions for the use of ulipristal acetate 5 mg.

Direct Healthcare Professional Communication (DHPC) on metamizole: risk of drug-induced liver injury PDF, 212KB, File is accessible Date: 15. December 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: metamizole

The marketing authorisation holders of metamizole-containing medicinal products in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) would like to inform you that cases of …

Direct Healthcare Professional Communication (DHPC) Gliolan® (5-aminolevulinic acid, 5-ALA): what to do in case of delayed surgery and information on fluorescence in non high-grade glioma PDF, 470KB, File is accessible Date: 01. December 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: 5-Aminolävulinsäure, 5-ALA

medac GmbH, in coordination with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM), provides information on the procedure for delayed operations and on fluorescence in non-high-grade gliomas.

Direct Healthcare Professional Communication (DHPC) on Gilenya® (fingolimod): updated recommendations to minimise the risk of drug-induced liver injury (DILI) PDF, 165KB, File is accessible Date: 10. November 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fingolimod

Novartis would like to inform you in agreement with European Medicines Agency (EMA) and Federal Institute for Drugs and Medical Devices, of cases of acute liver failure requiring liver transplant and clinically significant liver injury have …