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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).

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.

Information Letter on Axura® and Ebixa®: Overdosage due to administration errors PDF, 55KB, File is accessible Date: 29. October 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: memantine hydrochloride

Information for medical experts regarding overdosage due to administration errors of the medicinal products Axura® und Ebixa® containing memantine hydrochloride.