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Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing dolutegravir (Tivicay®, Triumeq®, Juluca®): neural tube defects in babies whose mothers became pregnant while taking dolutegravir PDF, 510KB, File is accessible Date: 04. June 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dolutegravir

There are reports from an observational study on neural tube defects in babies, whose mothers became pregnant while taking dolutegravir.

Information Letter on flupirtine: recall and revocation of marketing authorisation PDF, 36KB, File is accessible Date: 04. June 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: flupirtine

Following the European benefit-risk assessment, marketing authorisations of medicinal products containing the active substance flupirtine are revoked on an EU-wide level due to the risk of liver damage.

Dear Doctor Letter (Rote-Hand-Brief) on Lynparza® (olaparib): risk of medication errors due to new dosage forms PDF, 552KB, File is accessible Date: 29. May 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: olaparib

Lynparza® capsules and Lynparza® tablets must neither be substituted 1:1 nor on a milligramme-to-milligramme basis.

Dear Doctor Letter (Rote-Hand-Brief) on azithromycin: increased recurrence of haematological malignancies and mortality in patients following haematopoietic stem cell transplantation (HSCT) under azithromycin PDF, 948KB, File is accessible Date: 03. May 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: azithromycin

The clinical trial ALLOZITHRO on the prevention of bronchiolitis obliterans syndrome (BOS) in patients after allogeneic haematopoietic stem cell transplantation (HSCT) was discontinued prematurely.

Dear Doctor Letter (Rote-Hand-Brief) on Inhixa® (enoxaparin sodium): risk of self-activation of the safety device in unopened, unused pre-filled syringes PDF, 681KB, File is accessible Date: 18. April 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: enoxaparin sodium

The company Techdow Pharma Germany GmbH is circulating information on rare cases of premature self-activation of the safety device in unopened, unused pre-filled Inhixa syringes.

Dear Doctor Letter (Rote-Hand-Brief) on Xofigo® (radium 223 dichloride): contraindicated in combination with abiraterone acetate and prednisolone/prednisone PDF, 115KB, File is accessible Date: 20. March 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: radium 223 dichloride

The company Bayer AG issues information that an interim analysis of the randomised clinical trial in patients with castration-resistant metastatic prostate cancer has shown an increased risk of deaths and fractures in patients receiving radium …

Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing sonidegib (Odomzo® capsules): important information for minimising the teratogenic risk PDF, 133KB, File does not meet accessibility standards Date: 27. February 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: sonidegib

Medicinal products containing sonidegib are embryotoxic and/or teratogenic and can cause embryo-foetal death or severe birth defects when administered to pregnant women; therefore, Odomzo® must not be taken during pregnancy.
Active substance: …

Dear Doctor Letter (Rote-Hand-Brief) on Esmya® 5 mg tablets (ulipristal acetate): restrictions of use, warnings regarding serious liver injury as well as recommendations for monitoring liver function PDF, 161KB, File is accessible Date: 19. February 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Ulipristal acetate

After reports of serious liver damage, including acute liver failure, in patients treated with Esmya® temporary measures have been taken.

Dear Doctor Letter (Rote-Hand-Brief) on OCALIVA® (obeticholic acid): differential dosing recommendations in primary biliary cholangitis (PBC) patients with moderate and severe hepatic impairment PDF, 361KB, File is accessible Date: 09. February 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: obeticholic acid

Due to the risk of serious liver injury in patients with moderate and severe hepatic impairment, all patients are to be monitored by way of laboratory and clinical assessment for progression of the PBC disease during treatment with obeticholic …

Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing mycophenolate mofetil (MMF)/mycophenolic acid (MPA): updated recommendations for contraception PDF, 264KB, File is accessible Date: 07. February 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: mycophenolate

As mycophenolate mofetil (MMF) and mycophenolic acid (MPA) are known to be genotoxic, it is recommended that the male patient or his female partner use reliable contraception during treatment and for at least 90 days after the end of the …