BfArM - Federal Institute for Drugs and Medical Devices

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Information Letter on Isotonic Saline Solution Baxter, Clear-Flex plastic containers with Emoluer valves: Important safety information PDF, 197KB, File is accessible Date: 21. February 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: isotonic saline solution

The company Baxter Deutschland GmbH points out that Baxter has recently received an increased number of customer complaints referring to leakage of the Emoluer valves of Clear-Flex containers.

Information Letter on Olimel Peri/Olimel®: Reduction of maximal infusion rate per hour in children PDF, 552KB, File is accessible Date: 11. February 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: emulsion for infusion for parenteral nutrition

The company Baxter Deutschland GmbH points out that the posology given in the Package Leaflets and Summaries of Product Characteristics of Olimel Peri/Olimel nutrient solutions is to be altered with regard to the maximal infusion rate of …

Iron-containing medicinal products for parenteral use: realisation of the EU Commission's implementing decision Date: 07. February 2014 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: iron

In its notice of 18 December 2013, the Federal Institute for Drugs and Medical Devices has ruled the realisation of the implementing decision of the European Commission regarding iron-containing medicinal products for parenteral use.

Dear Doctor Letter on Carbomedac 10 mg/ml® (carboplatin): Recall of batch A130069B due to insoluble particles PDF, 45KB, File is accessible Date: 06. February 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: carboplatin

The company Medac Gesellschaft für klinische Spezialpräparate m.b.H. points out that the a.m. batch of the medicinal product Carbomedac 10 mg/ml® is being recalled due to insoluble crystalline particles. The concentrate for solution for …

Dear Doctor Letter (Rote-Hand-Brief) on combined hormonal contraceptives, including information material: Risk of venous thromboembolic events PDF, 507KB, File is accessible Date: 03. February 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: gestagen components: chlormadinone, desogestrel, dienogest, drospirenone, etonogestrel, gestodene, nomegestrol, norelgestromin, norgestimat

In coordination with the European Medicines Agency and the Federal Institute for Drugs and Medical Devices, the pharmaceutical manufacturers concerned are circulating information on new aspects of the risk of blood clots (venous thromboembolic …

Flupirtine: restrictions in the use of flupirtine-containing medicines Date: 27. January 2014 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: flupirtine

In its notice of 18 December 2013, the Federal Institute for Drugs and Medical Devices has ruled the realisation of the implementing decision of the European Commission regarding medicinal products with the active substance flupirtine.

Information Letter on Zyvoxid® i.v. (linezolid): Limited supply PDF, 97KB, File is accessible Date: 27. January 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: linezolid

The company Pfizer Pharma GmbH is circulating information that with immediate effect the medicinal product Zyvoxid® i.v. is available to a limited extent.

Dear Doctor Letter (Rote-Hand-Brief) on Erivedge® (vismodegib): Labelling of the bottle and Package Leaflet PDF, 303KB, File is accessible Date: 20. January 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: vismodegib

Important information on the labelling of the bottle and the Package Leaflet as a precautionary measure to ensure safe administration.

Dear Doctor Letter (Rote-Hand-Brief) on Abraxane®: Quality issues PDF, 401KB, File is accessible Date: 17. January 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: paclitaxel

Information on quality issues in connection with the medicinal product Abraxane® for intravenous use. Visible particles were discovered in the infusion bag.

Information Letter regarding Zyvoxid® 2 mg/ml solution for injection: Supply failure PDF, 122KB, File is accessible Date: 10. January 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: linezolid

The company Pfizer Pharma GmbH is circulating information that the medicinal product Zyvoxid® 2 mg/ml solution for injection can currently not be supplied.

Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing dihydroergotamine: Restrictions of indication PDF, 154KB, File is accessible Date: 06. January 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dihydroergotamine

New restrictions of certain indications have been decided for medicinal products containing dihydroergotamine.

Information Letter on Increlex® 10 mg/ml solution for injection PDF, 180KB, File is accessible Date: 23. December 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: mecasermin, recombinant human IGF-1

The company Ipsen Pharma GmbH is sending out information that the supply with Increlex® (mecasermin) is no longer interrupted.

Quinine (Limptar® N): hearing under the graduated plan procedure ("Stufenplanverfahren"), stage II Date: 20. December 2013 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: quinine

In its letter dated 19 December 2013, the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) has initiated a written hearing regarding the risk of serious haematological …

Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing temozolomide: risk of severe liver toxicity PDF, 213KB, File is accessible Date: 13. December 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: temozolomide

The companies concerned point out that cases of liver injury, including liver failure with lethal outcome, have been reported in patients treated with medicinal products containing temozolomide. The liver toxicity may not appear until several …

Dear Doctor Letter (Rote-Hand-Brief) on Iclusig® (ponatinib): Updated information on the risk of vascular occlusion PDF, 95KB, File is accessible Date: 09. December 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ponatinib

Extension of warnings to include the risk of severe vascular occlusion associated with ponatinib.

Diclofenac: realisation of the EU Commission's implementing decision Date: 06. December 2013 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: diclofenac

Based on the recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) and on the position of the Coordination Group (CMDh), the European Commission decided on 25 September 2013 to adapt …

Dear Doctor Letter (Rote-Hand-Brief) on EFIENT® (prasugrel): increased risk of serious bleeding PDF, 910KB, File is accessible Date: 03. December 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: prasugrel

The company Lilly Deutschland GmbH is circulating information that patients with unstable angina pectoris (UA)/NSTEMI receiving EFIENT® prior to diagnostic coronary angiography have an increased risk of serious bleeding.

Iclusig®: Risk of blood clots Date: 25. November 2013 Topics: Pharmakovigilanz Type: Risk information

Active substance: ponatinib

The Committee for Medicinal Products for Human Use (CHMP) recommends updating the product information of the leukaemia medicine Iclusig® (ponatinib) to include new warnings in order to minimise the risk of a higher rate of blood clots.

Dear Doctor Letter (Rote-Hand-Brief) on Oncaspar® solution for injection (pegasparaginase): Possible quality deficiency PDF, 364KB, File is accessible Date: 19. November 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pegasparaginase

The company Sigma-Tau Arzneimittel GmbH is circulating information that individual containers from different batches have exhibited fine cracks that can lead to leakage (assumed incidence: one in every 5,000 injection vials). Due to these fine …

Information Letter on Pixuvri® 29 mg powder for concentrate for solution for infusion (pixantrone): Risk of dosing errors PDF, 130KB, File is accessible Date: 19. November 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pixantrone

The company CTI Life Sciences Limited in Great Britain points out that there is a risk of dosing errors when taking Pixuvri® (active substance: pixantrone), since the dose recommended in the EU is different as compared to that stated in some …

Dear Doctor Letter (Rote-Hand-Brief) on Gilenya® (fingolimod): Hemophagocytic syndrome PDF, 1MB, File is accessible Date: 18. November 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fingolimod

The company Novartis Pharma GmbH is circulating information on reports of 2 cases of a hemophagocytic syndrome (HPS) leading to the deaths of patients with relapsing-remitting multiple sclerosis treated with fingolimod.

Dear Doctor Letter (Rote-Hand-Brief) on COSOPT-S® 20 mg/ml and 5 mg/ml eye drops in single-dose containers: Risk of eye injury PDF, 160KB, File is accessible Date: 18. November 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dorzolamide hydrochloride

The company MSD Sharp & Dohme GmbH is circulating information on changes in the design of the product resulting in instructions for use to be observed in order to avoid eye injury.

Dear Doctor Letter (Rote-Hand-Brief) on solutions for infusion that contain hydroxyethyl starch (HES): New contraindications and restrictions in indications
PDF, 513KB, File is accessible
Date: 15. November 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: hydroxyethyl starch

The marketing authorisation holders are circulating information on new contraindications to be observed and further restrictions in indications.

Dear Doctor Letter (Rote-Hand-Brief) on JEXT® Adrenalin Autoinjector: Recall on patient level due to quality deficiency PDF, 2MB, File is accessible Date: 12. November 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: adrenalin

As a precautionary measure, the company ALK-Abelló Arzneimittel GmbH is recalling five batches of the Adrenalin Autoinjector JEXT® in Germany: four batches of the 300 microgram strength and one batch of the 150 microgram strength. The batches …

Dear Doctor Letter (Rote-Hand-Brief) on Pegasys® pre-filled syringes (pegylated interferon alfa-2a): Counterfeit of batch B1299B03 PDF, 1MB, File is accessible Date: 11. November 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pegylated interferon alfa-2a

The company Roche Pharma AG is circulating information that a counterfeit of Pegasys® 180 microgram/0.5 ml (pegylated interferon alfa-2a), batch B1299B03 EXP 07 2015 has been discovered in Germany.

Dear Doctor Letter (Rote-Hand-Brief) on Septopal® 10 Batch 11L0504 and Septopal® 30 Batch 12C0503 (gentamicin): Recall due to quality deficiency PDF, 94KB, File is accessible Date: 08. November 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: gentamycin

The company Biomet Deutschland GmbH is recalling the a.m. two batches due to a mix-up of the inner sachets. The company cannot rule out the possibility of lacking sterility.

Jevtana® (cabazitaxel): Potential risk of incorrect dosing following preparation of Jevtana® PDF, 64KB, File is accessible Date: 29. October 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: cabazitaxel

The company Sanofi-Aventis Deutschland GmbH calls attention to the instructions for preparation of Jevtana®.

Dear Doctor Letter (Rote-Hand-Brief) on parenteral iron-containing medicinal products: Risk of serious hypersensitivity reactions PDF, 187KB, File is accessible Date: 28. October 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: iron

The marketing authorisation holders of iron-containing medicinal products for parenteral use are circulating information within a European safety review on the risk of serious hypersensitivity reactions as well as on the precautionary measures …

Information Letter on Increlex® 10 mg/ml solution for injection (mecasermin, recombinant human IGF-1): Interruption in supply PDF, 115KB, File is accessible Date: 18. October 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: mecasermin, recombinant human IGF-1

The company Ipsen Pharma GmbH is sending out information that as of immediately the medicinal product Increlex® 10 mg/ml solution for injection can no longer be supplied in Germany.

Use of valproate (and related substances) during pregnancy: initiation of a European safety review Date: 15. October 2013 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: valproate

At the request of Great Britain, the European Medicines Agency (EMA) has initiated a review procedure in accordance with Article 31 of Directive 2001/83/EC regarding valproate, valproic acid and related substances.