BfArM - Federal Institute for Drugs and Medical Devices

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Information letter on Xofigo® (radium 223 dichloride): Temporary shortage of the medicinal product and special temporary preparation instructions. PDF, 75KB, File is accessible Date: 07. November 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: radium-223-dichlorid

The company Bayer Vital GmbH is circulating information on a worldwide temporary shortage of the medicinal product Xofigo® as recently produced batches did not pass routine quality checks prior to release.

Information Letter on Xofigo® (radium 223 dichloride): Temporary shortage of the medicinal product PDF, 2MB, File is accessible Date: 05. November 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: radium-223-dichlorid

The company Bayer Vital GmbH is circulating information on a worldwide temporary shortage of the medicinal product Xofigo® as recently produced batches did not pass routine quality checks prior to release.

Dear Doctor Letter (Rote-Hand-Brief) on Beofenac® (aceclofenac): New contraindications and warnings PDF, 1MB, File is accessible Date: 28. October 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: aceclofenac

The company Almirall Hermal GmbH is circulating information that treatment with aceclofenac - similar to that with diclofenac and selective COX-2 inhibitors - is associated with an increased risk of arterial thrombotic events.

Information Letter on Buccolam®: Recall due to a potential quality defect PDF, 793KB, File is accessible Date: 09. October 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: midazolam

The company ViroPharma GmbH issues information on the recall of the medicinal product Buccolam®. During a routine inspection at the manufacturing site, the potential risk of a cross-contamination with another medicinal product produced at the …

Safety relevant information on Beta interferons: Risk of thrombotic microangiopathy and nephrotic syndrome PDF, 286KB, File is accessible Date: 20. August 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: interferon beta

In accord with the European Medicines Agency (EMA) and the marketing authorisation holders, the BfArM issues important safety information regarding the treatment of multiple sclerosis with medicinal products containing interferon beta.

Dear Doctor Letter (Rote-Hand-Brief) on domperidone: serious cardiac side effects PDF, 369KB, File is accessible Date: 20. August 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: domperidone

After conclusion of the European safety review of medicinal products containing domperidone, the marketing authorisation holders are circulating a joint Dear Doctor Letter with information on safety measures to minimise cardiac risks.

Amsidyl® (active substance amsacrine) 75 MG concentrate for solution for infusion
(PZN 07131886) – Information on the shortage of Amsidyl after detection of GMP deficiencies during manufacture PDF, 454KB, File is accessible Date: 21. July 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Amsacrine

The pharmaceutical entrepreneur has issued information on a lack of availability of Amsidyl® until presumably 2015 due to the GMP deficiencies determined at the manufacturing site.

Information Letter on Velcade 3.5 MG (PZN 00822831) – Further information regarding the precautionary recall of a batch of Velcade (DELSC01) PDF, 269KB, File is accessible Date: 16. July 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Bortezomib

As a follow-up to the already published precautionary recall of a batch of Velcade®, the pharmaceutical manufacturer has compiled further information.

Dantrolene sodium (DANTROLEN i.v.®): Use of filter needles to draw up reconstituted solution from new stock until further notice PDF, 1MB, File is accessible Date: 27. June 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dantrolene sodium

The company Norgine GmbH is circulating information that some vials of dantrolene sodium for intravenous use after reconstitution may contain visible particles of the active substance.

Dear Doctor Letter (Rote-Hand-Brief) on transdermal patches containing fentanyl: Possible life-threatening consequences of accidental exposure PDF, 1MB, File is accessible Date: 13. June 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fentanyl

The marketing authorisation holders are circulating information on possible life-threatening consequences of accidental exposure to patches containing fentanyl.

Information Letter on Procoralan®: Potentially dangerous bradycardia PDF, 1MB, File is accessible Date: 11. June 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ivabradine

The company Servier Deutschland GmbH has issued a reminder that specific conditions for use must be observed in order to avoid potentially dangerous bradycardia when administering the medicinal product Procoralan® containing ivabradine for …

Dear Doctor Letter (Rote-Hand-Brief) on Invirase® (saquinavir): Important new safety information on ECG monitoring PDF, 467KB, File is accessible Date: 28. May 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: saquinavir

The company Roche Pharma AG is circulating information on new recommendations regarding ECG monitoring in treatment-naïve patients receiving Invirase® (saquinavir). This Dear Doctor Letter is intended to emphasise the necessity of ECG …

Dear Doctor Letter (Rote-Hand-Brief) on Norditropin® SimpleXx® 10 mg/1.5 ml: Counterfeit PDF, 2MB, File is accessible Date: 23. May 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: somatropin

The company Novo Nordisk Pharma GmbH is circulating information on the discovery of a counterfeit cartridge of the medicinal product Norditropin® SimpleXx® 10 mg/1.5 ml (active substance: somatropin).

Information Letter on Buccolam®: Recall due to a potential quality defect PDF, 300KB, File is accessible Date: 09. May 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: midazolam

The company ViroPharma GmbH issues information on the recall of the medicinal product Buccolam®. During a routine inspection at the manufacturing site, the potential risk of a cross-contamination with another medicinal product produced at the …

Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing dihydroergotoxine: Restriction of indications PDF, 99KB, File is accessible Date: 27. March 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dihydroergotoxine

The company Sigma-Tau Arzneimittel GmbH is circulating information that there are several indications for which medicinal products with the active substance dihydroergotoxine must no longer be prescribed in the future.

Granocyte® (lenograstim): Risk of capillary leak syndrome PDF, 309KB, File is accessible Date: 20. March 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: lenograstim

The company Chugai Pharma Marketing is circulating information on the occurrence of capillary leak syndrome (CLS) following administration of lenogastrim (as also in the case of other G-CSF products) in patients undergoing chemotherapy, as …

Dear Doctor Letter (Rote-Hand-Brief) on Protelos® (strontium ranelate): Restriction of indication and recommendations for controls during administration PDF, 917KB, File is accessible Date: 11. March 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: strontium ranelate

The company Servier Deutschland GmbH is circulating information that use of Protelos is now restricted to the treatment of severe osteoporosis in postmenopausal women and adult men with a high risk of fractures who cannot be treated with other …

Information letter on Isotonic Saline Solution Baxter, Clear-Flex plastic containers with Emoluer valves: Recall due to leakage PDF, 91KB, File is accessible Date: 07. March 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: isotonic saline

In addition to the safety information of 18 February 2014, the company Baxter Deutschland GmbH is circulating information on the recall of several batches of the medicinal product Isotonic Saline Solution Baxter.

Information Letter on Doribax® 250 mg/500 mg (doripenem): Discontinuation and recall of stock in circulation PDF, 647KB, File is accessible Date: 05. March 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: doripenem

The company Janssen-Cilag GmbH points out that it will discontinue distribution of the medicinal product Doribax® 250 mg/500 mg (active substance: doripenem). The entire stock still on the market will be recalled on pharmacy level. This recall …

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 …

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 …

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.

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 …