BfArM - Federal Institute for Drugs and Medical Devices

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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.

Rote-Hand-Brief (Dear Doctor Letter) regarding Leflunomid medac® laboratory tests PDF, 474KB, File is accessible Date: 29. October 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: leflunomide

Correction of the information on laboratory tests to be performed when administering Leflunomid medac®.

Information Letter on Vfend®: possible occurrence of squamous cell carcinomas of the skin PDF, 370KB, File is accessible Date: 27. September 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: voriconazole

Important safety-relevant information on the potential risk of the occurence of squamous cell carcinomas of the skin in patients taking Vfend® (voriconazole) as long-term treatment.

Anti-diabetics containing rosiglitazone: Order of discontinuation in Germany due to cardiovascular risks and Dear Doctor Letter (Rote-Hand-Brief) PDF, 238KB, File is accessible Date: 24. September 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: rosiglitazone

In a decision dated 23 September 2010, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the recall of anti-diabetics containing rosiglitazone from the trade chain in Germany down to the pharmacy level. Due to the necessity …

Information Letter regarding Relistor®: Occurrence of gastrointestinal perforations PDF, 2MB, File is accessible Date: 13. September 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: methylnaltrexone bromide

Important safety information on the occurrence of gastrointestinal perforations in patients who received RELISTOR® (active substance: methylnaltrexone bromide) for subcutaneous injection.
An information letter including the Fachinformation

Main information on contrast media containing gadolinium: Risk of nephrogenic systemic fibrosis (NSF) PDF, 44KB, File is accessible Date: 13. September 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: gadolinium

Summarising information on the risk of nephrogenic systemic fibrosis in association with the administratiion of gadolinium-containing contrast media.

Dear Doctor Letter on Xyrem®: Risk of dosing errors PDF, 1MB, File is accessible Date: 12. August 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: sodium oxybate

Risk of dosing errors with Xyrem® (sodium oxybate) because gramme (g) and milliliter (ml) are easily confused.

Dear Doctor Letter (Rote-Hand-Brief) regarding Ketoprofen, topical formulations PDF, 58KB, File is accessible Date: 09. August 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ketoprofen

Important safety information about the risk of photosensivity reactions in association with topical uses of Ketoprofen.

Dear Doctor letter (Rote Hand Brief) on Cardioxane®: Secondary neoplasia in children PDF, 1MB, File is accessible Date: 26. July 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dexrazoxane

Important safety information on Cardioxane® (dexrazoxane) and increased risk for secondary neoplasia in children.

Dear Doctor letter on Invirase®: QT-prolongations PDF, 2MB, File is accessible Date: 15. July 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: saquinavir

Additional safety information on the arrhythmogenic risk due to QT and PR interval prolongations in association with Invirase (saquinavir).

Dear Doctor Letter on Perfalgan®: Inadvertent overdose in newborn babies and infants PDF, 1MB, File is accessible Date: 14. July 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: paracetamol i.v.

Important information on the risk of inadvertently overdosed intravenous infusion of paracetamol 10 mg/ ml to newborn babies and infants.

Dear Doctor Letters on temozolomide: Recall Date: 09. July 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: temozolomide

For precautionary reasons the pharmaceutical companies will recall certain batches of temozolomide.

Information Letter on Exelon® and Prometax® transdermal patches: incorrect administration and medication error PDF, 51KB, File is accessible Date: 29. April 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: rivastigmine

In association with the rivastigmine transdermal patches, Exelon® and Prometax®, cases of overdosage due to medication errors and incorrect administration have been reported.

Dear Doctor Letter (Rote-Hand-Brief) on Kepivance®: Restriction of indication PDF, 2MB, File is accessible Date: 20. April 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: palifermin

Indication for Kepivance® restricted to patients exposed to radiotherapy and chemotherapy for conditioning prior to autologous stem cell transplantation.

Dear Doctor Letter (Rote-Hand-Brief) on REGRANEX®: Extension of existing contraindications PDF, 79KB, File is accessible Date: 15. March 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: becaplermin

REGRANEX® (active substance: becaplermin) contraindicated for patients with malign diseases.