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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 …