BfArM - Federal Institute for Drugs and Medical Devices

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Dear Doctor Letter (Rote-Hand-Brief) on Eliquis®, Pradaxa®, Lixiana®/Roteas® and Xarelto®: use is not recommended in patients with antiphospholipid syndrome PDF, 1MB, File is accessible Date: 23. May 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: apixaban | dabigatran etexilate | edoxaban | rivaroxaban

Marketing authorisation holders inform that the use of direct oral anticoagulants (DOACs) in patients with antiphospholipid syndrome is not recommended.

Dear Doctor Letter (Rote-Hand-Brief) on Tyverb® (lapatinib): important update to Summary of Product Characteristics PDF, 872KB, File is accessible Date: 17. May 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Lapatinib

Novartis will provide information on changes with regard to the therapeutic indication (Section 4.1) of the Lapatinib Summary of Product Characteristics.

Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing biotin: risk of false laboratory test results due to biotin interferences PDF, 213KB, File is accessible Date: 15. May 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: biotin

Taking medicinal products, dietary supplements or dietary food for special medical purposes is associated with a risk of false positive or false negative laboratory test results.

Dear Doctor Letter (Rote-Hand-Brief) on modafinil: potential risk of severe congenital malformations PDF, 762KB, File is accessible Date: 09. May 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: modafinil

In coordination with the Federal Institute for Drugs and Medical Devices (BfArM), the marketing authorisation holders of medicinal products containing modafinil inform about new findings related to the use of modafinil during pregnancy.

Dear Doctor Letter (Rote-Hand-Brief) on domperidone: reminder regarding measures to minimise cardiac risks PDF, 1MB, File is accessible Date: 29. April 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: domperidone

In agreement with the Federal Institute for Drugs and Medical Devices (BfArM), the marketing authorisation holders of medicinal products containing domperidone would like to remind you of the safety measures from the year 2014.

Dear Doctor Letter (Rote-Hand-Brief) on Euthyrox® (levothyroxine) new formulation tablets: monitoring of patients switching between tablets Date: 10. April 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: levothyroxine

Merck Serono GmbH would like to inform you in agreement with the Federal Institute for Drugs and Medical Devices that a new formulation of Euthyrox® (levothyroxine) tablets will be available End of April/Beginning of May 2019.

Dear Doctor Letter (Rote-Hand-Brief) on fluoroquinolone antibiotics: serious and long-lasting, disabling and potentially permanent side effects PDF, 2MB, File is accessible Date: 08. April 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fluoroquinolones

The marketing authorisation holders of medicinal products containing fluoroquinolone are circulating information on the incidence of serious and potentially permanent side effects associated with fluoroquinolones administered systemically or …

Dear Doctor Letter (Rote-Hand-Brief) on Xeljanz® (tofacitinib): increased risk of pulmonary embolism and mortality in patients with rheumatoid arthritis PDF, 277KB, File is accessible Date: 29. March 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: tofacitinib

Pfizer Pharma would like to inform you that the recommended dose of Xeljanz® (active ingredient: tofacitinib) for the treatment of rheumatoid arthritis must not be exceeded.

Dear Doctor Letter (Rote-Hand-Brief) on Genvoya®, Stribild® und Tybost®: increased risk of treatment failure and increased risk of mother-to-child transmission of HIV infection PDF, 815KB, File is accessible Date: 26. March 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: elvitegravir | cobicistat

Gilead Sciences informs that treatment with elvitegravir- and cobicistat-containing drugs should not be started during pregnancy.

Information Letter on Dantrolene 20 mg powder for solution for injection (DANTRIUM IV): use filtration device provided with product to reduce risk of injection site reactions PDF, 373KB, File is accessible Date: 01. March 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Dantrolen

The company Norgine informs on a new filtration device (BBraun Mini-Spike) to reduce the risk of reactions at the injection site.