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Information letter regarding Methergin® (methylergometrine maleate): Withdrawal of Methergin® oral solution from the market, safety information for the use of Methergin® solution for injection PDF, 57KB, File is accessible Date: 14. October 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: methylergometrine maleate

The pharmaceutical manufacturer issues information on the withdrawal of Methergin® oral solution from the market due to case reports of adverse drug reactions in connection with medication errors/misuse in neonates. In addition, safety …

Dear Doctor Letter (Rote-Hand-Brief) on Revatio® (sildenafil citrate): Increased risk of mortality in paediatric patients with pulmonary arterial hypertension (PAH) PDF, 215KB, File is accessible Date: 06. October 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: sildenafil citrate

Important new safety information on the increased risk of mortality in paediatric patients with pulmonary arterial hypertension (PAH) in connection with the use of higher than recommended doses of Revatio® (sildenafil citrate).

Dear Doctor Letter (Rote-Hand-Brief) on Multaq® (dronedarone): Restrictions regarding the use of Multaq® PDF, 439KB, File is accessible Date: 30. September 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dronedarone

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has decided on restrictions as well as additional contraindications and warnings regarding the use of Multaq®.

Dear Doctor Letter (Rote-Hand-Brief) on Apidra® cartridges (insulin glulisine [produced by recombinant DNA technology]): Shortage of Apidra®

 PDF, 81KB, File is accessible Date: 26. September 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: insulin glulisine

Information on a temporary shortage in the supply of Apidra 3 ml cartridges. In Germany, this concerns the following products: Apidra® cartridge, Apidra® cartridge for OptiClik®, Apidra® SoloStar®, Apidra® OptiSet®.

Dear Doctor Letter (Rote-Hand-Brief) on Nplate® (romiplostim): Risk of disease progression of pre-existing myelodysplastic syndrome (MDS) to acute myeloid leukemia (AML) PDF, 427KB, File is accessible Date: 16. September 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: romiplostim

Important safety-relevant information on the risk of disease progression to an acute myeloid leukemia with romiplostin (Nplate®) use in patients with myelodysplastic syndrome (MDS).

Dear Doctor Letter (Rote-Hand-Brief) on Caelyx® (pegylated liposomal doxorubicin): Supply failure PDF, 114KB, File is accessible Date: 06. September 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pegylated liposomal doxorubicin

From the middle of September a temporary supply failure of Caelyx® (pegylated liposomal doxorubicin) is likely to ocur resulting in a further decline in patient supply.

Dear Doctor Letter (Rote-Hand-Brief) on Caelyx® (pegylated liposomal doxorubicin): Likely shortage PDF, 116KB, File is accessible Date: 08. August 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pegylated liposomal doxorubicin

Likely global shortage of Caelyx® (pegylated liposomal doxorubicin) possibly resulting in supply problems for patients in Germany.

Dear Doctor Letter (Rote-Hand-Brief) on Sprycel® (dasatinib): Potential risk of pulmonary arterial hypertension PDF, 363KB, File is accessible Date: 03. August 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dasatinib

The pharmaceutical entrepreneur is sending out a Dear Doctor Letter giving information on the potential risk of pre-capillary, pulmonary arterial hypertension (PAH) under treatment with Sprycel® (dasatinib).

Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing pioglitazone (Actos®, Competact®, Tandemact®): New contraindications and warnings due to a slightly increased risk of bladder cancer PDF, 155KB, File is accessible Date: 01. August 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pioglitazone

The pharmaceutical entrepreneur is sending out a Dear Doctor Letter on Actos®, Competact® and Tandemact® giving information on new contraindications and warnings due to a slightly increased risk of bladder cancer.

Dear Doctor Letter (Rote-Hand-Brief) on Vimpat® (lacosamide) 15 mg/ml syrup: Recall due to a quality defect PDF, 46KB, File is accessible Date: 29. July 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: lacosamide

As of 15 September 2011, the pharmaceutical entrepreneur is recalling the medicinal product Vimpat® 15 mg/ml syrup from the market due to a quality defect. Other pharmaceutical forms are not affected.

Dear Doctor Letter (Rote-Hand-Brief) on Multaq® (dronedarone): New study results on increased cardiovascular risks PDF, 321KB, File is accessible Date: 29. July 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dronedarone

New data from a prematurely discontinued study (PALLAS study) indicate a significantly increased risk of cardiovascular adverse events in patients with permanent atrial fibrillation due to treatment with dronedarone.

Dear Doctor Letter (Rote-Hand-Brief) on Cardioxane® (dexrazoxane): Restricted indications PDF, 279KB, File is accessible Date: 18. July 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dexrazoxane

As part of an arbitration by the EMA in 2017, the contraindications for children and adolescents listed in this dear Doctor Letter were partially removed.

Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing pioglitazone (actos®, Competact®, Tandemact®): Increased incidence of bladder cancer PDF, 178KB, File is accessible Date: 10. June 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pioglitazone

Important safety information on the use of medicinal products containing pioglitazone.

Information Letter regarding Regranex® Gel (becaplermin): Discontinuation of distribution in Europe PDF, 336KB, File is accessible Date: 10. June 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: becaplermin

According to information from the pharmaceutical manufacturer, the distribution of Regranex® Gel (becaplermin 0.01%) in Europe will be discontinued as of 30 June.

Information letter regarding Anemet® 200 mg tablets (dolasetron): Discontinuation of production PDF, 143KB, File is accessible Date: 26. April 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dolasetron

Due to the risk of arrhythmias in connection with the administration of Anemet® 200 mg tablets to adults for prevention and treatment of nausea and vomiting associated with cytostatic chemotherapy, the pharmaceutical manufacturer has renounced …

Dear Doctor Letter (Rote-Hand-Brief) on Thalidomide Celgene™ (thalidomide): Occurrence of thromboembolic events PDF, 129KB, File is accessible Date: 21. April 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: thalidomide

Important information on the occurrence of thromboembolic events associated with Thalidomide Celgene™ (thalidomide).

Information letter on Thyrogen® (thyrotropin alfa): Supply shortage due to a manufacturing issue and temporary treatment recommendations from the EMA PDF, 59KB, File is accessible Date: 11. April 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: thyrotropin alfa

An information letter on the treatment recommendations has been sent to attending physicians and pharmacies concerned.

Information letter on Onsenal® (celecoxibe): Company-led drug withdrawal for the indication "familial adenomatous polyposis" (FAP) PDF, 2MB, File is accessible Date: 08. April 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: celecoxibe

Important information on the company-led drug withdrawal of Onsenal® (celecoxibe) for the indication familial adenomatous polyposis.

Dear Doctor Letter (Rote-Hand-Brief) on Revlimid® (lenalidomide): Potential risk of second primary tumours PDF, 389KB, File is accessible Date: 01. April 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: lenalidomide

Important information on the potential risk of second primary tumours in patients treated with Revlimid® (lenalidomide).

Dear Doctor Letter (Rote-Hand-Brief) on TYGACIL® (tigecycline): Restrictions in all indications PDF, 44KB, File is accessible Date: 17. March 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: tigecycline

Important information on restrictions in all indications of TYGACIL® (tigecycline) due to increased mortality observed in clinical trials.

Dear Doctor Letter (Rote-Hand-Brief) on ZERIT® (stavudine): Restricted indications PDF, 419KB, File is accessible Date: 09. March 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: stavudine

Important information on restrictions in the indications of ZERIT® (stavudine) due to potentially serious adverse reactions.

Dear Doctor Letter (Rote-Hand-Brief) on Anemet 100 mg i.v.® (dolasetron): Renunciation of marketing authorisation PDF, 90KB, File is accessible Date: 18. February 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dolasetron

Due to the risk of arrhythmias in connection with the intravenous administration of dolasetron to adults for treatment of nausea and vomiting associated with cytostatic chemotherapy, the pharmaceutical manufacturer has renounced this marketing …

Dear Doctor Letter (Rote-Hand-Brief) on Vigil® (modafinil): Restricted indication and important safety information PDF, 104KB, File is accessible Date: 11. February 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: modafinil

A safety review by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has lead to a restriction of the indications of Vigil® (modafinil) to adults with excessive sleepiness associated with …

Dear Doctor Letter (Rote-Hand-Brief) on Octenisept® (octenidine hydrochloride, phenoxyethanol): Swelling and tissue damage following irrigation under pressure PDF, 2MB, File is accessible Date: 27. January 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: octenidine hydrochloride, phenoxyethanol

Warning against incorrect use of Octenisept®.

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).