BfArM - Federal Institute for Drugs and Medical Devices

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Direct Healthcare Professional Communication (DHPC) on Rubraca®▼(rucaparib-camsylate): interim data from Study CO-338-043 (ARIEL4) show a decrease in overall survival compared to standard of care PDF, 261KB, File is accessible Date: 06. May 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: rucaparib-camsylate

The interim data from Study CO-338-043 (ARIEL4) show a decrease in overall survival compared to standard of care.

Direct Healthcare Professional Communication (Rote-Hand-Brief) on Accupro of the company Pfizer: Recall due to nitrosamine contamination PDF, 70KB, File is accessible Date: 28. April 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Quinapril hydrochloride

Pfizer informs about a precautionary recall of all strengths and pack sizes of the medicinal product Accupro at pharmacy level, as investigations have identified nitrosamine contamination.

Direct Healthcare Professional Communication (Rote-Hand-Brief) on Accuzide of the company Pfizer: Recall due to nitrosamine contamination PDF, 99KB, File is accessible Date: 28. March 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Quinapril hydrochloride, hydrochlorothiazide

Pfizer informs about a precautionary recall of all strengths and package sizes of the medicinal product Accuzide at pharmacy level, as nitrosamine contamination has been detected by investigations.

Dihydroergotamine and dihydroergotoxine: unfavourable risk-benefit ratio Date: 11. March 2022 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: dihydroergotamine | dihydroergotoxine

In a notice dated 15. January 2018, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled further suspension of marketing authorisation until 01. February 2020

Direct Healthcare Professional Communication (DHPC) on Xagrid® (anagrelide hydrochloride): Risk of thrombosis including cerebral infarction upon abrupt treatment discontinuation PDF, 81KB, File is accessible Date: 22. February 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: anagrelide hydrochloride

Shire Pharmaceuticals Ireland Limited (a subsidiary of Takeda Pharmaceuticals Company Limited) would like to inform you that there is an increased risk of thrombotic complications, including cerebral infarction, upon abrupt anagrelide discontinuation.

Direct Healthcare Professional Communication (DHPC) on Mavenclad (cladribine): risk of serious liver injury and new recommendations about liver function monitoring PDF, 145KB, File is accessible Date: 16. February 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: cladribine

Merck Healthcare Germany GmbH provides information about liver damage, including serious cases, reported during treatment of patients with Mavenclad®.

Direct Healthcare Professional Communication (DHPC) on Berlthyrox® (levothyroxine sodium): new composition and new trade name L-Thyroxine BC® - Information and control of patients during the changeover PDF, 2MB, File is accessible Date: 10. January 2022 Topics: Aktuelles Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: levothyroxine sodium

From mid-January 2022, a new formulation of Berlthyrox® will be available under the new trade name L-Thyroxine BC® and with a new package design.

Direct Healthcare Professional Communication (DHPC) on irinotecan-containing drugs: Drug toxicity in patients with reduced UGT1A1 activity PDF, 471KB, File is accessible Date: 21. December 2021 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: irinotecan hydrochloride 3 H2O

Marketing authorization holders of irinotecan-containing drugs inform that UGT1A1 genotyping may be helpful to avoid the risk of neutropenia and diarrhea.

Contact persons for Pharmacovigilance Date: 29. November 2021 Topics: Pharmakovigilanz Type: Article

Contact persons for Pharmacovigilance

Direct Healthcare Professional Communication (DHPC) on mitomycin of the company Medac: Intravenous administration until further notice only with the use of a particle filter PDF, 95KB, File is accessible Date: 03. November 2021 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: mitomycine

The Direct Healthcare Professional Communication (DHPC) on restrictions on the use of mitomycin preparations of the company Medac GmbH for intravenous administration has been lifted. The use of a particle filter for intravenous administration is no …

Direct Healthcare Professional Communication (DHPC) on Forxiga® (Dapagliflozin) 5 mg: the medicinal product should no longer be used for the treatment of Type 1 Diabetes PDF, 194KB, File is accessible Date: 29. October 2021 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dapagliflozin

AstraZeneca, in agreement with the European Medicines Agency (EMA) and the German Federal Institute for Drugs and Medical Devices (BfArM), informs that Forxiga® (dapagliflozin) 5 mg is no longer approved for the treatment of patients with type 1 …

Direct Healthcare Professional Communication (DHPC) on CHAMPIX: batches to be recalled due to presence of N-nitroso-varenicline above the accepted intake limit PDF, 214KB, File is accessible Date: 30. September 2021 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: varenicline

The company Pfizer Pharma GmbH informs that all Champix (varenicline) batches that were found to contain N-nitroso-varenicline above the acceptable level of intake set at EU level are being recalled.

Direct Healthcare Professional Communication (DHPC) on combined hormonal contraceptives: Prescribing those with the lowest risk of venous thromboembolism and use of the officially mandated education material material. PDF, 321KB, File is accessible Date: 30. September 2021 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: combined hormonal contraceptives

The Federal Institute for Drugs and Medical Devices (BfArM) would like to inform you once again, that combined hormonal contraceptives (CHCs) with the progestogens levonorgestrel, norethisterone or norgestimate have the lowest risk of venous …

Direct Healthcare Professional Communication (DHPC) on Mitem® 20 mg: Restrictions of use for intravenous administration PDF, 125KB, File does not meet accessibility standards Date: 20. September 2021 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: mitomycine

Restriction of use due to a possible drug risk during intravenous administration.

Tetrazepam-containing medicines: revocation of approval Date: 19. July 2021 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: tetrazepam

Marketing authorizations for tetrazepam-containing drugs are being revoked because the risk-benefit ratio is unfavorable.

Direct Healthcare Professional Communication (DHPC) on CHAMPIX: Batch recall due to contamination with N-nitroso-varenicline above Pfizer's acceptable daily dose PDF, 71KB, File is accessible Date: 15. July 2021 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Varenicline

The company Pfizer would like to inform that several batches of the drug CHAMPIX are being recalled

Direct Healthcare Professional Communication (DHPC) on ▼Xeljanz (tofacitinib): increased risk of major adverse cardiovascular events and malignancies with use of tofacitinib relative to TNF-alpha inhibitors PDF, 109KB, File is accessible Date: 06. July 2021 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: tofacitinib

Pfizer Europe MA EEIG provides information about an increased incidence of myocardial infarction with tofacitinib compared with TNF-alpha inhibitors, as well as an increased incidence of malignancy in patients with rheumatoid arthritis (RA) who were …

Basis for the ongoing monitoring and improvement of drug safety Date: 01. July 2021 Topics: Arzneimittelsicherheit Pharmakovigilanz Type: Article

Taking medicine can be associated with certain risks. All medicinal products are carefully monitored after having been placed on the EU market.

Information Letter on Lynparza® 50 mg hard capsules (active ingredient olaparib): discontinuation of production at the end of 2021 PDF, 83KB, File is accessible Date: 29. June 2021 Topics: Pharmakovigilanz Aktuelles Type: Direct Healthcare Professional Communication

Active substance: olaparib

AstraZeneca informs that the production of Lynparza® 50 mg hard capsules (active ingredient: olaparib) will be discontinued at the end of 2021.

Direct Healthcare Professional Communication (DHPC) on Minprostin®, Prepidil®, Propess® (dinoprostone-containing drugs): updates to product information on risk reduction of uterine hyperstimulation, uterine rupture, and fetal/neonatal death. PDF, 295KB, File is accessible Date: 28. June 2021 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dinoprostone

The product information for dinoprostone-containing drugs (Minprostin®, Prepidil®, Propess®) is updated.

Information Letter on INOmax® 800 ppm mol/mol, gas for medical use: difficulties with closing cylinder valves after use PDF, 127KB, File is accessible Date: 18. June 2021 Topics: Pharmakovigilanz Aktuelles Type: Direct Healthcare Professional Communication

Active substance: Nitric Oxide

The company Linde Healthcare AB informs that INOmax® cylinders that are not completely empty cannot be closed properly after opening.

Direct Healthcare Professional Communication (DHPC) on Amiodaron-hameln 50 mg/ml Concentrate for Solution for Injection/Infusion: visual inspection required due to possible crystallization PDF, 164KB, File is accessible Date: 17. June 2021 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: amiodarone

The company Hameln Pharma GmbH would like to inform that there is an increased potential for crystallization in ampoules.

Direct Healthcare Professional Communication (DHPC) on Venclyxto® (venetoclax) film coated tablets: updated recommendations on tumour lysis syndrome (TLS) in CLL patients PDF, 110KB, File is accessible Date: 10. June 2021 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: venetoclax

AbbVie in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) would like to inform you of fatal cases of TLS.

Direct Healthcare Professional Communication (DHPC) on Azazitidin 25 mg/ml: letter to healthcare professionals about potential risk of incorrect reconstitution (medication error) PDF, 257KB, File is accessible Date: 20. May 2021 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: azacitidine

The marketing authorization holders of Azacitidin 25 mg/ml would like to inform in agreement with the Federal Institute for Drugs and Medical Devices (BfArM) of the new 150 mg azacitidine presentation on the market and the potential risk of …

Ifosfamide: review of encephalopathy risk Date: 23. April 2021 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: ifosfamide

The CMDh, having considered the PRAC assessment report and recommendation, agreed by majority that the benefits of ifosfamide solutions for infusion continue to outweigh their risks in the treatment of different types of cancers, including various …

Direct Healthcare Professional Communication (DHPC) on Eylea® 40 mg/ml (aflibercept solution for intravitreal injection): higher risk of intraocular pressure increase with the pre-filled syringe PDF, 468KB, File is accessible Date: 15. April 2021 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: aflibercept

Bayer, in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM), would like to inform of cases of increased intraocular pressure.

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.