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818 results

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Flupirtine: implementation of revocation of marketing authorisation Date: 24. May 2018 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: flupirtine

In its notices and/or ascertainment decision of 26 April 2018, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the realisation of the unanimous CMDh position of 21 March 2018.

Dolutegravir (Tivicay®, Triumeq®): New study suggests risk of birth defects in babies born to women who were treated for HIV infection Date: 22. May 2018 Topics: Pharmakovigilanz Type: Risk information

Active substance: dolutegravir

The European Medicines Agency (EMA) is currently evaluating preliminary results from a study which found 4 cases of birth defects.

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.

Benzodiazepines/benzodiazepine like products and opioids: Concomitant use Date: 12. April 2018 Topics: Pharmakovigilanz Type: Risk information

Active substance: benzodiazepines | opioids

The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) recommends texts for the product informations of benzodiazepines/benzodiazepine like products and opioids.

Fiasp®: Colour change for insulin injection Fiasp® to avoid mix-ups with Tresiba® Date: 23. March 2018 Topics: Pharmakovigilanz Type: Risk information

Active substance: insulin aspart

The colour of cartridges of the pre-filled pens and vials of the rapid-acting insulin Fiasp® is changing from yellow to red and yellow, as there have been reports of cases where patients mistakenly injected Fiasp® instead of the long-acting …

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 …