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Direct Healthcare Professional Communication (DHPC) on Miltefosin (Impavido® 10 mg/50 mg Capsules): new warning about ocular changes, including keratitis PDF, 638KB, File is accessible Date: 05. February 2021 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: miltefosine

The company Paesel und Lorei GmbH & Co. KG informs in coordination with the Federal Institute for Drugs and Medical Devices (BfArM) that in a few case reports complications of the eye (including keratitis) occurred under treatment with …

Direct Healthcare Professional Communication (DHPC) on Alkindi® (hydrocortisone granules in capsules for opening): risk of acute adrenal insufficiency when switching from crushed or compounded oral hydrocortisone formulations PDF, 798KB, File is accessible Date: 04. February 2021 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: hydrocortisone

Diurnal Europe B.V. informs about the report of an adrenal crisis in an infant who was switched from soluble hydrocortisone tablets to Alkindi®.

Ulipristal acetate 5 mg: temporary suspension of marketing authorisation for medicinal products for the treatment of uterine fibroids Date: 02. February 2021 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: ulipristal acetate

The Federal Institute for Drugs and Medical Devices (BfArM) has revoked the provisional suspension of the marketing authorisations for medicinal products and ordered changes to the marketing authorisations.

Direct Healthcare Professional Communication (DHPC) on ulipristal acetate 5 mg: indications for uterine fibroids restricted due to concerns of severe liver injury PDF, 681KB, File is accessible Date: 01. February 2021 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ulipristal acetate

The marketing authorization holders, in coordination with the European Medicines Agency (EMA) and the German Federal Institute for Drugs and Medical Devices (BfArM), inform about new restrictions for the use of ulipristal acetate 5 mg.

Retinoids: updated measures for pregnancy prevention as well as warnings on neuropsychiatric disorders after oral use Date: 07. January 2021 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: acitretin | adapalene | alitretinoin | bexarotene | isotretinoin | tazarotene | tretinoin

The BfArM requires pharmaceutical companies to report annually all pregnancies reported in connection with the use of acitretin, alitretinoin and isotretinoin.

Direct Healthcare Professional Communication (DHPC) on metamizole: risk of drug-induced liver injury PDF, 212KB, File is accessible Date: 15. December 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: metamizole

The marketing authorisation holders of metamizole-containing medicinal products in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) would like to inform you that cases of …

Direct Healthcare Professional Communication (DHPC) Gliolan® (5-aminolevulinic acid, 5-ALA): what to do in case of delayed surgery and information on fluorescence in non high-grade glioma PDF, 470KB, File is accessible Date: 01. December 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: 5-Aminolävulinsäure, 5-ALA

medac GmbH, in coordination with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM), provides information on the procedure for delayed operations and on fluorescence in non-high-grade gliomas.

Hydroxychloroquine and Chloroquine: psychiatric disorders Date: 27. November 2020 Topics: Pharmakovigilanz Type: Risk information

Active substance: hydroxychloroquine, chloroquine

Current information about psychiatric disorders for Chloroquine and Hydroxychloroquine.

Direct Healthcare Professional Communication (DHPC) on Gilenya® (fingolimod): updated recommendations to minimise the risk of drug-induced liver injury (DILI) PDF, 165KB, File is accessible Date: 10. November 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fingolimod

Novartis would like to inform you in agreement with European Medicines Agency (EMA) and Federal Institute for Drugs and Medical Devices, of cases of acute liver failure requiring liver transplant and clinically significant liver injury have …

Direct Healthcare Professional Communication (DHPC) on Tecfidera® (dimethyl fumarate): updated recommendations in the light of cases of progressive multifocal leukoencephalopathy (PML) in the setting of mild lymphopenia PDF, 90KB, File is accessible Date: 09. November 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dimethyl fumarate

Biogen Netherlands B.V. informs that cases of progressive multifocal leukoencephalopathy (PML) have been reported in patients treated with Tecfidera with existing mild lymphopenia (lymphocyte value ≥ 0.8 x 109/l and below the lower standard …

Direct Healthcare Professional Communication (DHPC) on Esbriet®: important safety update and new recommendations to prevent Drug-Induced Liver Injury (DILI) Date: 29. October 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Pirfenidone

Roche Pharma Ltd informs about severe cases of drug-induced liver injury (DILI) recently reported using Esbriet® (Pirfenidone).

Direct Healthcare Professional Communication (DHPC) on systemic and inhaled fluoroquinolones: risk of heart valve regurgitation/incompetence PDF, 128KB, File is accessible Date: 29. October 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fluoroquinolones

The marketing authorisation holders of fluoroquinolone antibiotics products would like to inform you about the risk of heart valve regurgitation/incompetence associated with fluoroquinolones for systemic and inhalation use.

EU regulators request nitrosamine testing of metformin medicines (CHMP meeting highlights 12-15 October 2020) Date: 16. October 2020 Topics: Pharmakovigilanz Type: Risk information

Active substance: metformin

EU regulators request nitrosamine testing of metformin medicines

Dear Doctor Letter (Rote-Hand-Brief) on Kybella® 10 mg/ml solution for injection (deoxycholic acid): risk of injection-site necrosis PDF, 270KB, File is accessible Date: 15. October 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: deoxycholic acid

The Marketing Authorisation Holder (MAH) informs about the risk of injection-site necrosis.

Panexcell Clinical Laboratories Priv. Ltd.: conduct of studies in India Date: 14. October 2020 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: vgarious (in Germany parenteral iron sucrose)

The BfArM has provisionally ordered the suspension of the above-mentioned generic drug approvals in its decision of October 7, 2020.

Remdesivir (Veklury®): PRAC checks signal for kidney damage Date: 06. October 2020 Topics: Pharmakovigilanz Type: Risk information

Active substance: remdesivir

PRAC has begun reviewing a safety signal for acute renal damage in some COVID-19 patients treated with Veklury® (Remdesivir).

Ranitidine: EMA reviews ranitidine-containing drugs based on detection of NDMA Date: 29. September 2020 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: ranitidine

The Federal Institute for Drugs and Medical Devices (BfArM) has ordered the temporary suspension of all holders of marketing authorisations for medicinal products containing ranitidine.

Dexamethasone: review of dexamethasone for treating adults with COVID-19 requiring respiratory support Date: 18. September 2020 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: dexamethasone

The European Medicines Agency (EMA) supports the use of dexamethasone in COVID-19 patients on oxygen or artificial respiration.

Leuprorelin-containing depot medicinal products: handling errors with depot formulations Date: 06. August 2020 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: leuprorelin

With its decision of 29 July 2020, the BfArM implements the unanimous decision of the CMDh of 25 June 2020 for depot drugs containing leuprorelin.

Fluorouracil,capecitabine, tegafur and flucytosine: recommendation for testing and treatment Date: 04. August 2020 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: fluorouracil | capecitabine | tegafur | flucytosine

The Federal Institute for Drugs and Medical Devices (BfArM) implements the decision of the European Commission with a notice in the national graduated plan procedure.

Methocarbamol/paracetamol-containing medicinal products: benefits continue to outweigh risks Date: 03. August 2020 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: methocarbamol | paracetamol

With regard to the combination drug methocarbamol/paracetamol 380 mg/300 mg, the final decision of the EU Commission was issued on 10.06.2020.

Direct Healthcare Professional Communication (DHPC) on leuprorelin-containing depot drugs: need to strictly follow the instructions regarding preparation and administration to reduce the risk of application errors PDF, 85KB, File is accessible Date: 30. July 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: leuprorelin

The marketing authorisation holders of depot medicines containing leuprorelin would like to inform about application errors which could possibly lead to a reduced efficacy.

Yondelis® (trabectedin): review of efficacy due to study discontinuation Date: 24. July 2020 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: trabectedin

EMA has recommended that the use of Yondelis (trabectedin) in treating ovarian cancer remain unchanged following a review of a study that investigated Yondelis as a third-line treatment in patients with ovarian cancer.

Nitrosamines: EMA to provide guidance on avoiding nitrosamines in human medicines Date: 09. July 2020 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: nitrosamine

EMA finalises opinion on presence of nitrosamines in medicines.

Fosfomycin-containing medicinal products: re-evaluation of the risk-benefit ratio according to the current state of scientific knowledge Date: 03. July 2020 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: Fosfomycin

The BfArM informs about the initiation of a European risk assessment procedure according to Art. 31 of Directive 2001/83/EC for fosfomycin.

Direct Healthcare Professional Communication (DHPC) on 5-Fluorouracil (i.v.), capecitabine and tegafur containing products: pre-treatment testing to identify DPD-deficient patients PDF, 109KB, File is accessible Date: 04. June 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: 5-fluorouracil, capecitabine, tegafur

The marketing authorisation holders of medicines containing 5-fluorouracil i.v. (5-FU), capecitabine or tegafur, would like to inform you that patients with partial or complete dihydropyrimidine dehydrogenase (DPD) deficiency are at an …

Direct Healthcare Professional Communication (DHPC) on flucytosine: updated recommendations for the use in patients with dihydropyrimidine dehydrogenase (DPD) deficiency PDF, 97KB, File is accessible Date: 04. June 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Flucytosine

Mylan (Meda Pharma GmbH & Co KG) would like to inform you that the treatment with flucytosine is contraindicated in patients with known complete dihydropyrimidine dehydrogenase (DPD) deficiency due to the risk of life-threatening toxicity.

Hydroxychloroquine: renewed warning of risks when used to treat COVID-19 Date: 02. June 2020 Topics: Pharmakovigilanz Type: Risk information

Active substance: hydroxychloroquine, chloroquine

The European Medicines Agency (EMA) again warns about the risks of using hydroxychloroquine (and chloroquine) to treat COVID-19.

Direct Healthcare Professional Communication (DHPC) on tolperisone: a reminder of the negative risk-benefit balance if the use is outside the authorised indication PDF, 952KB, File is accessible Date: 02. June 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: tolperisone

The marketing authorisation holders of tolperisone containing drugs are once again informing, that since 2013 tolperisone is only authorised for the symptomatic treatment of spasticity after a stroke in adult patients.

Cyproterone-containing medicines: review of meningioma risk Date: 19. May 2020 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: cyproterone

The PRAC recommendations were adopted by the Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) by consensus on 25 March 2020.