BfArM - Federal Institute for Drugs and Medical Devices

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Dear Doctor Letter (Rote-Hand-Brief) on Eligard® (leuprorelin acetate): medication errors due to overtightening of the safety needle PDF, 559KB, File is accessible Date: 14. December 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: leuprorelin acetate

The company Astellas is circulating information on medication errors reported in connection with leakage of the medicinal product from the syringe..

Dear Doctor Letter (Rote-Hand-Brief) on Radium 223 dichloride (Xofigo®): increased risk of death and fractures in a randomised clinical trial with Xofigo® used in combination with abiraterone acetate and prednisolone/prednisone PDF, 36KB, File is accessible Date: 12. December 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: radium 223 dichloride

The company Bayer is circulating information on an increased incidence of deaths and fractures in a randomised clinical trial (15396/ERA-223 study) in patients with chemotherapy-naϊve castration-resistant prostate cancer (CRPC) receiving …

Terfenadine: closer monitoring of the side-effect profile PDF, 77KB, File is accessible Date: 04. December 2017 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: terfenadine

After a hearing regarding terfenadine, including evaluation of the safety report, no changes in the benefit/risk profile could be determined.

Dear Doctor Letter (Rote-Hand-Brief) on cladribine (Litak®, Leustatin®): changes in the product informations due to the risk of progressive multifocal leukoencephalopathy (PML) PDF, 101KB, File is accessible Date: 04. December 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: cladribine

The companies Lipomed GmbH and Janssen-Cilag GmbH are circulating information on the risk of progressive multifocal leukoencephalopathy (PML) associated with cladribine therapy which can occur up to several years after treatment with cladribine.

Xofigo®: EMA restricts use of prostate cancer medicine Xofigo Date: 04. December 2017 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: Radium-223 dichloride

Medicine should only be used after two previous treatments or when other treatments cannot be taken.

European Database on Adverse Drug Reaction Reports Date: 28. November 2017 Topics: Pharmakovigilanz Type: Article

The European database of suspected adverse drug reactions (ADRs) allows you to view data on suspected adverse drug reactions, also known as adverse drug reactions (ADRs), for medicines approved in the European Economic Area (EEA).

Dear Doctor Letter (Rote-Hand-Brief) on misoprostol (Misodel®): reports on excessive uterine tachysystole PDF, 409KB, File is accessible Date: 27. November 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: misoprostol

The company Ferring Arzneimittel GMBH is circulating information on reports of excessive uterine tachysystole that will possibly not subside with the use of tocolysis.

Dear Doctor Letter (Rote-Hand-Brief) on Gilenya®: new contraindications in patients with cardiac disorders PDF, 426KB, File is accessible Date: 07. November 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fingolimod

The company Novartis is circulating information on new contraindications in patients with cardiac disorders.

Dear Doctor Letter (Rote-Hand-Brief) on human Epoetins: new warnings on severe cutaneous adverse reactions PDF, 217KB, File is accessible Date: 04. October 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: epoetins

The marketing authorisation holders of all human epoetins are circulating information on cases of drug-induced Stevens Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), some of which were fatal.

Information letter on Dacogen® (decitabine): changes regarding instructions for reconstitution and dilution of Dacogen® 50 MG, powder for concentrate for solution for infusion PDF, 485KB, File is accessible Date: 08. September 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: decitabin

The company Janssen is circulating information that the reconstituted solution of Dacogen® must be diluted to a final concentration in the range 0.15 to 1.0 MG/ML in order to comply with the updated Chapter 5.1.10 of the European Pharmacopoeia.

Dear Doctor Letter (Rote-Hand-Brief) on Levact® (bendamustine): increased mortality observed in recent clinical studies with bendamustine PDF, 506KB, File is accessible Date: 29. August 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: bendamustine

The company Astellas is circulating information that an increased mortality was observed in recent clinical studies when bendamustine was used in non-approved combination treatments or outside the approved indications. Fatal toxicities were …

Information letter on ERWINASE ® 10,000 IU/vial powder for solution for injection: precautionary measures when administering ERWINASE vials from batches 181a* and 182a* Date: 14. August 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: asparaginase

Due to shortage, ERWINASE® 10,000 IU/vial powder for solution for injection is currently only available under consideration of the provisions of Section 73 (3) AMG.

Counterfeits of the medicinal product VELCADE® 3.5 mg powder for solution for injection discovered in Germany Date: 14. August 2017 Topics: Pharmakovigilanz Type: Risk information

Active substance: bortezomib

The Federal Institute for Drugs and Medical Devices (BfArM) is issuing information on counterfeits of the medicinal product VELCADE 3.5 mg powder for solution for injection by Janssen-Cilag International NV, Belgium which were was found in …

Information letter on Trisenox® (arsenic trioxide): import from third country in order to avert shortages Date: 03. August 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: arsenix trioxide

The company Teva GmbH is circulating information on the fact that due to problems in the manufacture of Trisenox there will be a shortage on the European market during mid/late August 2017. However, these manufacturing issues do not affect the …

Counterfeits of the medicinal product Xeplion® 150 mg extended-release suspension for injection (batches GFB4D00_BG-RO and GEB3Z00_BG-RO) have reached the German market (including amendments of 2 August 2017, 28 July 2017 and 26 July 2017) Date: 02. August 2017 Topics: Pharmakovigilanz Type: Risk information

Active substance: paliperidon

The Federal Institute for Drugs and Medical Devices (BfArM) has received new information on a further batch concerned in the case of counterfeits of the medicinal product Xeplion 150 mg extended-release suspension for injection (active …

Omnitrope® 15 mg / 1.5 ml solution for injection (somatropin) Batch EL9738: Counterfeit being offered in German packaging Date: 18. July 2017 Topics: Pharmakovigilanz Type: Risk information

Active substance: somatropin

The Federal Institute for Drugs and Medical Devices (BfArM) refers to counterfeits of the medicinal product Omnitrope® 15 mg / 1.5 ml solution for injection by the company Sandoz reported in France, Denmark and Mexico. The medicinal product …

Arixtra® (fondaparinux sodium): shortage following interrupted production due to a minor defect affecting the needle guard PDF, 248KB, File is accessible Date: 18. July 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fondaparinux sodium

The company Aspen Pharma Trading Limited is circulating information on the fact that a minor defect affecting the needle guard of some Arixtra syringes has led to quarantine of several batches and interrupted production.

Dear Doctor Letter (Rote-Hand-Brief) on Imbruvica® (ibrutinib): risk of hepatitis B re-activation PDF, 490KB, File is accessible Date: 18. July 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ibrutinib

The company Janssen-Cilag GmbH is circulating information on the fact that cases of hepatitis B virus (HBV) re-activation have occurred during treatment with Imbruvica®. Therefore, patients should be examined with regard to HBV infection prior …

Marketing authorisations based on studies conducted by the company Micro Therapeutic Research Labs in India: suspension of marketing authorisations Date: 13. July 2017 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: various

In a notice dated 13 July 2017, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the provisional suspension of generic marketing authorisations based on clinical trials conducted by the company Micro Therapeutic Research …

Introduction of a patient alert card for medicinal products containing valproate and related substances Date: 13. July 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: valproate and related substances

In a notice dated 10 April 2017, the Federal Institute for Drugs and Medical Devices (BfArM) ruled the introduction of a patient alert card for medicinal products containing valproate as a supplementary risk minimisation measure. The companies …