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Dear Doctor Letter (Rote-Hand-Brief) on Dianeal®, Extraneal®, Nutrineal®: Risk of occurrence of aseptic peritonitis
 PDF, 44KB, File is accessible Date: 26. January 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: peritoneal dialysis solutions

New information on the possible presence of endotoxins in batches of the peritoneal dialysis solutions Dianeal®, Extraneal®, and Nutrineal® and the associated increased risk of occurrence of aseptic peritonitis.

Dear Doctor Letter (Rote-Hand-Brief) on Multaq® (dronedarone): Severe liver injury
 PDF, 146KB, File is accessible Date: 24. January 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dronedarone

Important safety-relevant information on the occurrence of severe liver injury and on necessary control tests.

Dear Doctor Letter (Rote-Hand-Brief) on Cubicin® (daptomycin): Cases of eosinophilic pneumonia
 PDF, 2MB, File is accessible Date: 21. January 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: daptomycin

Important safety information on the connection between Cubicin® (daptomycin) and eosinophilic pneumonia.

Dear Doctor Letter (Rote-Hand-Brief) on Vistide® (cidofovir): Serious adverse reactions following off-label use
 PDF, 145KB, File is accessible Date: 13. January 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: cidofovir

Call for reporting of all suspected cases of adverse drug reactions in association with the use of Vistide®.

Dear Doctor Letter (Rote-Hand-Brief) on Dianeal®, Extraneal®, Nutrineal®: Risk of occurrence of aseptic peritonitis PDF, 65KB, File is accessible Date: 27. December 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: peritoneal dialysis solution

Increased endotoxin concentrations which lead to an increased risk of occurrence of aseptic peritonitis have been found in batches of the peritoneal dialysis solutions Dianeal®, Extraneal® and Nutrineal®.

Dear Doctor Letter (Rote-Hand-Brief) on Revlimid® (lenalidomide): Occurrence of venous and arterial thromboembolic events PDF, 1MB, File is accessible Date: 27. December 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: lenalidomide

Important safety-relevant information on the occurrence of venous and arterial thromboembolic events associated with Revlimid® (lenalidomide).

Dear Doctor Letter (Rote-Hand-Brief) on Thelin® (sitaxentan): Withdrawal from the market PDF, 108KB, File is accessible Date: 27. December 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: sitaxentan

Withdrawal of Thelin® (sitaxentan) from the market due to unpredictable progression of serious hepatic impairment.

Dear Doctor Letter (Rote-Hand-Brief) on Nplate® (romiplostim): Possible risk of thrombotic/thromboembolic events PDF, 2MB, File is accessible Date: 15. December 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: romiplostin

Important safety-relevant information for medical experts regarding the revised dose adjustment in patients with immune thrombocytopenic purpura (ITP) as well as the warnings for administration in ITP patients with hepatic impairment.

Dear Doctor Letter (Rote-Hand-Brief) on Sutent®: Possible risk of osteonecrosis of the jaw PDF, 44KB, File is accessible Date: 10. December 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: sunitinibe

Important safety-relevant information on the potential risk of osteonecrosis of the jaw in cancer patients treated with sunitinibe (Sutent®) associated with concomitant or previous administration of bisphosphonates.

Information Letter on Sabril®: MRI findings reveal brain anomalies and motion disorders PDF, 47KB, File is accessible Date: 29. October 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: vigabatrine

During the ongoing safety monitoring of Sabril® (vigabatrine), case reports on MRI findings of brain anomalies and motion disorders were analysed.