BfArM - Federal Institute for Drugs and Medical Devices

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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.

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.

Direct Healthcare Professional Communication (DHPC) on donepezil: QTc interval prolongation and torsade de pointes PDF, 146KB, File is accessible Date: 13. December 2021 Type: Direct Healthcare Professional Communication

Active substance: donepezil

The marketing authorization holders of donepezil-containing drugs inform that post-marketing cases of QTc interval prolongation and torsade de pointes associated with the use of donepezil have been reported.

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 …