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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 …

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 …

Dear Doctor Letter (Rote-Hand-Brief) on new contraindications of Saccharomyces boulardii (Saccharomyces cerevisiae HANSEN CBS 5926) in seriously ill or immunocompromised patients Date: 22. January 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Saccharomyces boulardii

The marketing authorisation holders of the medicinal products concerned issue information on rare cases of fungemia that led to death in seriously ill patients.

Information Letter on noradrenaline PDF, 3MB, File is accessible Date: 17. January 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: noradrenaline

The company Aguettant issues information on the marketing of a solution for infusion containing noradrenaline in two new ready-for-use strengths.

Information Letter on Haldol® (tablets, oral drops, solution, solution for injection) and Haldol Decanoat Depot®: clarification regarding Janssen-Cilag GmbH's Dear Doctor Letter of 21 December 2017 PDF, 261KB, File is accessible Date: 15. January 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: haloperidol

Due to questions regarding the recently circulated Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing haloperidol, the company Janssen-Cilag GmbH (Haldol®-Janssen) would like to clarify the aspects raised most frequently.

Dear Doctor Letter (Rote-Hand-Brief) on contrast media containing gadolinium: updated recommendations for use PDF, 388KB, File is accessible Date: 10. January 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: gadolinium

The marketing authorisation holders concerned are circulating information on indications confirmed by the European Medicines Agency (EMA) regarding low levels of gadolinium deposition in the brain following administration of contrast media …

Dear Doctor Letter (Rote-Hand-Brief) on Haldol® and Haldol Decanoat Depot® (haloperidol): changes in the indications and posology PDF, 689KB, File is accessible Date: 22. December 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: haloperidol

The company Janssen-Cilag wishes to inform that the European Medicines Agency (EMA) has conducted a procedure to harmonise the SmPCs, labelling and package leaflets of preparations containing haloperidol.

Oral and rectal dosage forms of antiemetic agents containing dimenhydrinate and diphenhydramine for children up to the age of 3 years Date: 22. December 2017 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: dimenhydrinate | diphenhydramine

The Federal Institute for Drugs and Medical Devices (BfArM) issues information on the conclusion of the graduated plan procedure ("Stufenplanverfahren") regarding the use of oral and rectal antiemetic agents containing …

Mycophenolate: Updated recommendations on contraceptive measures for women and men
Date: 21. December 2017 Topics: Pharmakovigilanz Type: Risk information

Active substance: mycophenolate

The European Medicines Agency (EMA) has updated its recommendations on contraceptive measures for women and men taking medicinal products that contain mycophenolate.

Medicinal products containing modified-release paracetamol: measures for risk minimisation and to reduce harm in case of overdose Date: 15. December 2017 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: paracetamol - modified release

The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) confirms the PRAC recommendation that the marketing authorisations of medicinal products containing modified or prolonged release paracetamol shall be …

Dear Doctor Letter (Rote-Hand-Brief) on Eligard® (leuprorelin acetate): medication errors due to overtightening of the safety needle PDF, 559KB, File is accessible Date: 14. December 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: leuprorelin acetate

The company Astellas is circulating information on medication errors reported in connection with leakage of the medicinal product from the syringe..

Dear Doctor Letter (Rote-Hand-Brief) on Radium 223 dichloride (Xofigo®): increased risk of death and fractures in a randomised clinical trial with Xofigo® used in combination with abiraterone acetate and prednisolone/prednisone PDF, 36KB, File is accessible Date: 12. December 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: radium 223 dichloride

The company Bayer is circulating information on an increased incidence of deaths and fractures in a randomised clinical trial (15396/ERA-223 study) in patients with chemotherapy-naϊve castration-resistant prostate cancer (CRPC) receiving …

Terfenadine: closer monitoring of the side-effect profile PDF, 77KB, File is accessible Date: 04. December 2017 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: terfenadine

After a hearing regarding terfenadine, including evaluation of the safety report, no changes in the benefit/risk profile could be determined.

Dear Doctor Letter (Rote-Hand-Brief) on cladribine (Litak®, Leustatin®): changes in the product informations due to the risk of progressive multifocal leukoencephalopathy (PML) PDF, 101KB, File is accessible Date: 04. December 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: cladribine

The companies Lipomed GmbH and Janssen-Cilag GmbH are circulating information on the risk of progressive multifocal leukoencephalopathy (PML) associated with cladribine therapy which can occur up to several years after treatment with cladribine.

Xofigo®: EMA restricts use of prostate cancer medicine Xofigo Date: 04. December 2017 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: Radium-223 dichloride

Medicine should only be used after two previous treatments or when other treatments cannot be taken.

European Database on Adverse Drug Reaction Reports Date: 28. November 2017 Topics: Pharmakovigilanz Type: Article

The European database of suspected adverse drug reactions (ADRs) allows you to view data on suspected adverse drug reactions, also known as adverse drug reactions (ADRs), for medicines approved in the European Economic Area (EEA).

Dear Doctor Letter (Rote-Hand-Brief) on misoprostol (Misodel®): reports on excessive uterine tachysystole PDF, 409KB, File is accessible Date: 27. November 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: misoprostol

The company Ferring Arzneimittel GMBH is circulating information on reports of excessive uterine tachysystole that will possibly not subside with the use of tocolysis.

Dear Doctor Letter (Rote-Hand-Brief) on Gilenya®: new contraindications in patients with cardiac disorders PDF, 426KB, File is accessible Date: 07. November 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fingolimod

The company Novartis is circulating information on new contraindications in patients with cardiac disorders.

Dear Doctor Letter (Rote-Hand-Brief) on human Epoetins: new warnings on severe cutaneous adverse reactions PDF, 217KB, File is accessible Date: 04. October 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: epoetins

The marketing authorisation holders of all human epoetins are circulating information on cases of drug-induced Stevens Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), some of which were fatal.

Information letter on Dacogen® (decitabine): changes regarding instructions for reconstitution and dilution of Dacogen® 50 MG, powder for concentrate for solution for infusion PDF, 485KB, File is accessible Date: 08. September 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: decitabin

The company Janssen is circulating information that the reconstituted solution of Dacogen® must be diluted to a final concentration in the range 0.15 to 1.0 MG/ML in order to comply with the updated Chapter 5.1.10 of the European Pharmacopoeia.

Dear Doctor Letter (Rote-Hand-Brief) on Levact® (bendamustine): increased mortality observed in recent clinical studies with bendamustine PDF, 506KB, File is accessible Date: 29. August 2017 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: bendamustine

The company Astellas is circulating information that an increased mortality was observed in recent clinical studies when bendamustine was used in non-approved combination treatments or outside the approved indications. Fatal toxicities were …