BfArM - Federal Institute for Drugs and Medical Devices

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Information letter on Zelboraf®: Potentiation of radiation damage PDF, 105KB, File is accessible Date: 20. October 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: vemurafenib

The company Roche Pharma AG is circulating information, that cases of severe radiation damage have been reported in patients treated with radiation prior to, during or subsequent to treatment with Zelboraf.

Codeine: review of the risk-benefit ratio of codeine-containing drugs for the treatment of cough in children and adolescents Date: 16. October 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: codeine

Treatment of cough in children younger than 12 years with medicinal products containing codeine is no longer permitted due to the risk of respiratory depression.

Educational material: Hearing of parallel importers pursuant to the graduated plan ("Stufenplan") Date: 13. October 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: different

Parallel importers are requested to comment in a hearing pursuant to the graduated plan.

Information Letter on Reminyl®: Serious skin reactions; Stevens-Johnson Syndrome and acute generalised exanthematous pustulosis PDF, 377KB, File is accessible Date: 22. September 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Galantaminhydrobromid

The company Janssen-Cilag is circulating information on a new warning for Reminyl®.

Dear Doctor Letter (Rote-Hand-Brief) on Betmiga® (mirabegron): New recommendations concerning the risk of increased blood pressure PDF, 413KB, File is accessible Date: 07. September 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: mirabegron

The company Astellas Pharma GmbH is circulating information that serious cases of hypertension and increased blood pressure have been reported under treatment with mirabegron.

Fumaderm: progressive multifocal leukoencephalopathy (PML), hearing within a graduated plan procedure ("Stufenplanverfahren"), stage II Date: 04. September 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: Fumarsäureester

After receiving reports of adverse reactions of currently nine cases of progressive multifocal leukoencephalopathy (PML) in connection with the use of Fumaderm®, the BfArM considers amendments of the section on adverse events in the product …

Olysio® (simeprevir) in combination with Sovaldi® (sofosbuvir): Risk of severe arrhythmias if used concomitantly with amiodarone Date: 21. August 2015 Topics: Pharmakovigilanz Type: Risk information

Active substance: simeprevir, sofosbuvir

In accordance with the evaluation of cardiac safety of the concomitant administration of Harvoni®, Daklinza® and Sovaldi® with amiodarone, the Pharmacovigilance Risk Assessment Committee (PRAC) has also revised the medicinal product Olysio® …

Dear Doctor Letter (Rote-Hand-Brief) on InductOs 1.5 mg/ml powder, solvent and matrix for implantation matrix: Possible temporary shortage of the medicinal product PDF, 77KB, File is accessible Date: 13. August 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dibotermin alfa

The company Medtronic BioPharma B.V. is circulating information that InductOs is expected to run out of stock as of the end of October 2015.

Ibuprofen-containing medicines: cardiovascular risk Date: 27. July 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: ibuprofen

In its notice of 22 July 2015, the BfArM has ruled the realisation of the decision of the Co-ordination group for Mutual Recognition and Decentralised Procedures - Human (CMDh) of 20 May 2015 regarding medicinal products containing …

Dear Doctor Letter (Rote-Hand-Brief) on the use of intrauterine devices (IUDs): Risk of uterine perforation PDF, 436KB, File is accessible Date: 23. July 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: levonorgestrel

In view of updated results of the "European Active Surveillance Study for Intrauterine Devices” (EURAS-IUD), the company Jenapharm GmbH & Co. KG is circulating information on the investigation of the use of copper-bearing intrauterine …

Petnidan® Syrup, 50 mg/ml oral solution: Possibility of counterfeits of the medicinal product in the legal supply chain in Germany Date: 15. July 2015 Topics: Pharmakovigilanz Type: Risk information

Active substance: ethosuximide

The BfArM has received information that counterfeit packs of the medicinal product Petnidan® Syrup, 50 mg/ml oral solution (Marketing Authorisation Holder: Desitin Arzneimittel GmbH) are on the market in Turkey in German packaging.

Information Letter on Dacogen 50 mg, powder for concentrate for solution for infusion: Changes regarding instructions for reconstitution and shelf life PDF, 555KB, File is accessible Date: 10. July 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: decitabine

The company Janssen-Cilag GmbH is circulating information on measures to improve stability for reconstitution and shelf life of Dacogen.

Information Letter on SGLT2 inhibitors: Risk of diabetic ketoacidosis PDF, 186KB, File is accessible Date: 10. July 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: canagliflozin, capagliflozin, empagliflozin

The companies AstraZeneca AB, Boehringer Ingelheim International GmbH and Janssen-Cilag International N.V. are circulating information on the risk of diabetic ketoacidosis under treatment with SGLT2 inhibitors.

Viagra®: Possibility of counterfeits of the medicinal product in the legal supply chain in Germany Date: 02. July 2015 Topics: Pharmakovigilanz Type: Risk information

Active substance: Sildenafil

The Italian authority AIFA has informed the BfArM that the customs in Italy confiscated counterfeit medicinal products of the company Pfizer's prescription-only potency drug Viagra® 100 mg film-coated tablets.

Saxagliptin: EMA investigates irregularities in large cardiovascular study (SAVOR) Date: 25. June 2015 Topics: Pharmakovigilanz Type: Risk information

Active substance: Saxagliptin

On its website, the French supervisory authority (ANSM) has reported a possibly increased mortality due to infections during the course of a study performed with the active substance saxagliptin (SAVOR: Saxagliptin Assessment of Vascular …

SGLT2 inhibitors: initiation of a European safety review to evaluate the risk of diabetic ketoacidosis Date: 16. June 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: canagliflozin | dapagliflozin | empagliflozin

The BfArM issues information on the initiation of a European safety review according to Article 20 of Regulation (EC) No. 726/2004 regarding SGLT2 inhibitors.

Information letter on Corotrop® 10 mg/10 ml solution for injection: Shortage PDF, 22KB, File is accessible Date: 16. June 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: milrinone

The company Sanofi-Aventis Deutschland GmbH is circulating information that the medicinal product Corotrop® 10 mg/10 ml solution for injection is temporarily not available due to capacity issues at the manufacturing site.

Information letter on Kineret® (anakinra) 100 mg and 100 mg/0.67 ml solution for injection in a pre-filled syringe: Visible solid deposits on the surface of the needle PDF, 155KB, File is accessible Date: 16. June 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: anakinra

The Swedish company Orphan Biovitrum AB (Sobi) issues information on deposits of the active substance on the surface of the needle.

Hydroxyzine: effects on heart rhythm Date: 20. May 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: hydroxyzine

The Co-ordination group for Mutual Recognition and Decentralised Procedures - Human (CMDh) has unanimously decided further measures to minimise the risk of arrhythmias.

Dear Doctor Letter (Rote-Hand-Brief) on Gilenya® (fingolimod): First reported case of progressive multifocal leukoencephalopathy (PML) PDF, 344KB, File is accessible Date: 04. May 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fingolimod

The company Novartis Pharma GmbH is circulating information on the first case report of PML in a patient taking fingolimod for multiple sclerosis (MS) without previous treatment with natalizumab or other immunosuppressive medicines.

Information Letter on Sustiva® (efavirenz) 30 mg/ml oral solution: Discontinuation and recommendation for switching patients to Sustiva® capsules or tablets PDF, 624KB, File is accessible Date: 04. May 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: efavirenz

The company Bristol-Myers Squibb GmbH & Co. KGaA is circulating information on discontinuation of Sustiva® 30 mg/ml oral solution by the end of October 2015.

Dear Doctor Letter (Rote-Hand-Brief) on Imnovid® (pomalidomide): Risk of serious hepatotoxicity, interstitial lung disease and cardiac failure PDF, 519KB, File is accessible Date: 04. May 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pomalidomide

The company Celgene GmbH is circulating safety information regarding reduction of the risk of serious hepatotoxicity, interstitial lung disease and cardiac failure.

Pulmozyme: Possibility of counterfeits of the medicinal product in the legal supply chain in Germany Date: 24. April 2015 Topics: Pharmakovigilanz Type: Risk information

Active substance: dornase alfa

The BfArM has received information that counterfeits of the medicinal product Pulmozyme 2500 U/2.5 ml (nebuliser solution) are possibly on the market in Germany.

Dear Doctor Letter (Rote-Hand-Brief) on Hydroxyzine (Atarax® and AH3®N film-coated tablets): New restrictions due to the risk of QT-interval prolongation PDF, 367KB, File is accessible Date: 17. April 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: hydroxyzine

The company UCB Pharma GmbH is circulating information on new restrictions in order to further minimise the known risk of QT-interval prolongation attributed to medicinal products containing hydroxyzine.

Viread: Possibility of counterfeits of the medicinal product in the legal supply chain in Germany Date: 10. April 2015 Topics: Pharmakovigilanz Type: Risk information

Active substance: tenofovir

The BfArM has received information that counterfeits of the centrally licensed medicinal product Viread 245 mg film-coated tablets are possibly on the market in Germany.

Medicinal products containing dimethyl fumarate (Tecfidera®, Fumaderm®): Progressive multifocal leukoencephalopathy (PML) in connection with the administration of medicinal products containing dimethyl fumarate Date: 07. April 2015 Topics: Pharmakovigilanz Type: Risk information

Active substance: dimethyl fumarate

The BfArM issues information that in Germany up to now overall 9 cases of PML (progressive multifocal leukoencephalopathy) have been reported in connection with the administration of Fumaderm® and 2 cases in connection with the administration …

Quinine for nocturnal leg cramps (Limptar® N): BfArM's notice regarding changes of the product informations within a national graduated plan procedure ("Stufenplanverfahren"), including a restriction of the indication, amongst others due to the risk of severe blood count changes (thrombocytopenias) Date: 02. April 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: quinine

The BfArM issues information on a national graduated plan procedure ("Stufenplanverfahren") regarding the active substance quinine for the indication nocturnal leg cramps.

Sofosbuvir: Arrhythmias as a possible interaction with other direct-acting antiviral agents (DAA) for the treatment of hepatitis C in combination with agents that could cause bradycardia (e.g. amiodarone) Date: 27. March 2015 Topics: Pharmakovigilanz Type: Risk information

Active substance: sofosbuvir

Signs of potential arrhythmias, especially the possibly life-threatening slowing of the heart rate (bradycardia), have become known especially due to case reports from France.

Metformin: Update of Summaries of Product Characteristics/Package Leaflets regarding contraindication for patients with impaired renal function Date: 27. March 2015 Topics: Pharmakovigilanz Type: Risk information

Active substance: metformin

The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) issues information that the Summaries of Product Characteristics/Package Leaflets of medicinal products containing metformin have …

Dear Doctor Letter (Rote-Hand-Brief) on Ketoconazole HRA®: Risk of hepatotoxicity PDF, 842KB, File is accessible Date: 11. March 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ketoconazole

The company HRA Pharma is circulating information on the hepatotoxicity risk of its ketokonazole-containing medicinal product for treatment of endogenous Cushing's syndrome as well as on the measures to be taken prior to and during treatment.