BfArM - Federal Institute for Drugs and Medical Devices

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Direct Healthcare Professional Communication (DHPC) on Cystagon 150 mg of the company Recordati Rare Diseases: Recall of batch T2208 PDF, 347KB, File is accessible Date: 27. February 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Mercaptamine bitartrate

Recordati Rare Diseases informs about a precautionary recall of batch T2208 of the medicinal product Cystagon 150 mg capsules.

Information Letter on Separation of the combined indications for methotrexate medac 25 mg/ml solution for injection (in vials) PDF, 132KB, File is accessible Date: 15. February 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Methotrexate

The product Methotrexat medac 25 mg/ml solution for injection (in vials) with the marketing authorisation number 80379.00.00 is only available for oncological indications.

Direct Healthcare Professional Communication (DHPC) on amfepramone-containing medicines: Withdrawal and revocation of approvals PDF, 479KB, File is accessible Date: 06. February 2023 Type: Direct Healthcare Professional Communication

Active substance: amfepramone

Amfepramone-containing medicines are no longer available on the EU market, as marketing authorisations have been revoked respectively withdrawn.

Direct Healthcare Professional Communication (DHPC) on Caprelsa® (vandetanib): Restriction of indication PDF, 284KB, File is accessible Date: 02. January 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: vandetanib

Sanofi informs that data from a randomized trial and an observational study show insufficient efficacy of vandetanib in patients without identified RET mutations.

Direct Healthcare Professional Communication (DHPC) on terlipressin: Serious or fatal respiratory failure and sepsis/septic shock in patients with type 1 hepatorenal syndrome (type 1 HRS) PDF, 448KB, File is accessible Date: 01. December 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: terlipressin

Terlipressin may cause severe or lethal respiratory failure in patients with hepatorenal syndrome type 1 (HRS-1) with a higher frequency than previously known, as well as increase the risk of sepsis or septic shock.

Direct Healthcare Professional Communication (DHPC) on Xalkori® (Crizotinib): Visual disturbances, including risk of vision loss, need for monitoring in pediatric patients PDF, 212KB, File does not meet accessibility standards Date: 11. November 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Crizotinib

Pfizer informs that pediatric patients should be screened for visual impairment.

Direct Healthcare Professional Communication (DHPC) on chlormadinone acetate and nomegestrol acetate: Measures to minimise the risk of meningioma PDF, 412KB, File is accessible Date: 09. November 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: chlormadinone, nomegestrol

The marketing authorisation holders of chlormadinone- and nomegestrol- containing medicines would like to inform you that medicinal products containing chlormadinone acetate or nomegestrol acetate are only indicated when other interventions are …

Direct Healthcare Professional Communication (DHPC) on Imbruvica® (ibrutinib): New risk minimisation measures, including dose modification recommendations, due to the increased risk for serious cardiac events PDF, 167KB, File does not meet accessibility standards Date: 03. November 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ibrutinib

Janssen-Cilag International NV in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) would like to inform you that Ibrutinib increases the risk of fatal and serious cardiac arrhythmias …

Direct Healthcare Professional Communication (DHPC) on Custodiol® cardioplegic solution/ organ preservation solution, 500 ml and 1000 ml bottles: risk of visible particles in the solution, use of a filter PDF, 307KB, File does not meet accessibility standards Date: 07. October 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance:

Direct Healthcare Professional Communication (DHPC) on Custodiol® cardioplegic solution/ organ preservation solution, 500 ml and 1000 ml bottles: risk of visible particles in the solution, use of a filter

Direct Healthcare Professional Communication (DHPC) on Natpar 100 microgram/dose powder and solvent for solution for injection of the company Takeda: Discontinuation of manufacturing at the end of 2024 and update on shortage of 100 microgram/dose PDF, 302KB, File is accessible Date: 07. October 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Parathyroid hormone

Takeda informs of an expected supply shortage for the medicinal product Natpar 100 micrograms/dose strength due to manufacturing challenges.

Direct Healthcare Professional Communication (DHPC) on Nulojix® (belatacept): Risk of medication errors due to change in maintenance dose from 5 mg/kg to 6 mg/kg PDF, 217KB, File does not meet accessibility standards Date: 04. October 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Belatacept

Bristol Myers Squibb in agreement with the European Medicines Agency and the Federal Institute for Drugs and Medical Devices (BfArM) would like to inform you that With the implementation of a new manufacturing process, the maintenance dose for …

Direct Healthcare Professional Communication (DHPC) on Rubraca®▼(rucaparib-camsylate): restriction of indication PDF, 270KB, File is accessible Date: 08. August 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: rucaparib-camsylate

The company Clovis Oncology Ireland Ltd--Limited informs about a limitation of the indication with regard to monotherapy in adult patients.

Direct Healthcare Professional Communication (DHPC) on Hydroxyethyl starch (HES) solutions for infusion: suspension of marketing authorisations due to continued use in contraindicated patient populations with increased risk of serious harm PDF, 269KB, File is accessible Date: 01. July 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Hydroxyethyl starch, HES

Based on the results of the latest application study, the provisional suspension of marketing authorizations for HES-containing infusion solutions in the EU has been ordered. Germany will implement the suspension order as of November 24, 2023.

Direct Healthcare Professional Communication (DHPC) on dexmedetomidine: risk of increased mortality in intensive care patients ≤ 65 years of age PDF, 262KB, File does not meet accessibility standards Date: 15. June 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dexmedetomidine

Marketing authorization holders of dexmedetomidine-containing drugs provide information on results from the SPICE III study, in which the use of dexmedetomidine was associated with a higher risk of mortality compared with other sedatives in the age …

Direct Healthcare Professional Communication (DHPC) on Defitelio® (defibrotide): Do not use for prophylaxis of veno-occlusive disease (VOD) after post-hematopoietic stem-cell transplantation (HSCT) PDF, 158KB, File is accessible Date: 13. June 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: defibrotide

Gentium S.r.l would like to inform you that the Study 15-007 was stopped due to futility. Defitelio® is not to be used as prophylaxis for veno-occlusive disease.

Direct Healthcare Professional Communication (DHPC) on Ocaliva®▼ (obeticholic acid): New contraindication for treatment of primary biliary cholangitis (PBC) in decompensated cirrhosis or history of hepatic decompensation. PDF, 249KB, File is accessible Date: 09. June 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: obeticholic acid

The company Intercept Pharma International Ltd. informs about a new contraindication for the treatment of primary biliary cholangitis (PBC).

Direct Healthcare Professional Communication (DHPC) on Fosfuro® 3000 mg granules for oral solution (fosfomycin trometamol): Deletion of the indication perioperative antibiotic prophylaxis for transrectal prostate biopsy in adult men PDF, 1MB, File is accessible Date: 20. May 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fosfomycin trometamol

Apogepha Arzneimittel GmbH as the marketing authorisation holder of Fosfuro® 3000 mg informs that Fosfuro® 3000 mg (fosfomycin trometamol) is not authorised in the indication perioperative antibiotic prophylaxis in transrectal prostate biopsy in …

Direct Healthcare Professional Communication (Rote-Hand-Brief) on Natpar 100 micrograms/dose powder and solvent for solution for injection of the company Takeda: Expected supply shortage from July 1st, 2022 PDF, 212KB, File is accessible Date: 09. May 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Parathyroid hormone

Takeda informs of an expected supply shortage for the medicinal product Natpar 100 micrograms/dose strength due to manufacturing challenges.

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.

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 …