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Dear Doctor Letter (Rote-Hand-Brief) on Fumaderm® initial / Fumaderm® (fumaric acid ester): Measures to reduce the risk of progressive multifocal leukoencephalopathy (PML)
 PDF, 713KB, File is accessible Date: 24. November 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fumaric acid ester

After a hearing under the graduated plan procedure ("Stufenplanverfahren"), stage II and conclusion of the variation worksharing procedure, the company Biogen Idec GmbH is circulating information on measures to reduce the risk of progressive …

Dear Doctor Letter (Rote-Hand-Brief) on Thalidomide Celgene® (Thalidomide): Reduction of starting dose when combined with melphalan in patients over 75 years of age PDF, 422KB, File is accessible Date: 10. November 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Thalidomid

The company Celgene GmbH is circulating information that the starting dose of Thalidomide Celgene should be reduced when combined with melphalan and prednisone (MPT) in patients over 75 years of age with untreated multiple myeloma.

Dear Doctor Letter (Rote-Hand-Brief) on CellCept®: Serious risk of teratogenicity – strengthened advice on pregnancy prevention for women and men Date: 10. November 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: mycophenolate mofetil

The company Roche Pharma is circulating information that the advice regarding pregnancy prevention when using CellCept® has been strengthened considerably.

Dear Doctor Letter (Rote-Hand-Brief) on InductOs 1.5 mg/ml powder, solvent and matrix for implantation matrix: Shortage PDF, 72KB, File is accessible Date: 05. November 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dibotermin alfa

The company Medtronic BioPharma B.V. is circulating information that the medicinal product InductOs can currently not be supplied.

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.

Dear Doctor Letter (Rote-Hand-Brief) on Xalkori® (crizotinib): New recommendations regarding the risk of cardiac insufficiency PDF, 224KB, File is accessible Date: 14. October 2015 Topics: Presse Type: Direct Healthcare Professional Communication

Active substance: crizotinib

The company Pfizer Pharma GmbH is circulating information that severe, sometimes lethal, cases of cardiac insufficiency have been reported in patients with ALK-positive NSCLC treated with crizotinib.

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.

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.

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 …

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.

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.

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.

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.

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.

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Dear Doctor Letter (Rote-Hand-Brief) on Rapiscan® (regadenoson): New information regarding the minimisation of the stroke risk and prolongation of Rapiscan-induced seizures after administration of aminophylline PDF, 194KB, File is accessible Date: 22. December 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: regadenoson

The company Rapidscan Pharma Solutions is circulating new safety information. Postponement of regadenoson administration should be considered in patients with uncontrolled hypertension.

Dear Doctor Letter (Rote-Hand-Brief) on SonoVue® (sulphur hexafluoride): Revised contraindications, warnings and precautions PDF, 589KB, File is accessible Date: 18. December 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: sulphur hexafluoride

The company Bracco Imaging Deutschland GmbH is circulating information on rare but severe arrhythmias, sometimes fatal, in patients with cardiovascular instability during stress echocardiography procedures with SonoVue® used in combination …

Dear Doctor Letter (Rote-Hand-Brief) on CellCept® (mycophenolate mofetil): New warnings with regard to the risk of hypogammaglobulinaemia and bronchiectasis PDF, 2MB, File is accessible Date: 17. December 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: mycophenolate mofetil

The company Roche Pharma AG is circulating new safety information regarding the risk of hypogammaglobulinaemia and bronchiectasis for all products that release mycophenolic acid as the active metabolite.

Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing valproate (and related substances): Risks for the unborn child in case of exposure during pregnancy Date: 12. December 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: valproat, related substances

Important new information and increased safety warnings with regard to medicinal products containing valproate and related substances (sodium valproate, valproic acid, valproate semisodium and valpromide).

Dear Doctor Letter (Rote-Hand-Brief) on Procoralan® (ivabradine): New contraindication and recommendations for minimisation of risks of cardiovascular events and severe bradycardias PDF, 1MB, File is accessible Date: 11. December 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ivabradine

The company Servier Deutschland GmbH is circulating information that concomitant use of ivabradine with verapamil or diltiazem is now contraindicated.

Dear Doctor Letter (Rote-Hand-Brief) on Tecfidera® (dimethyl fumarate): Suspected case of progressive multifocal leukoencephalopathy (PML) PDF, 195KB, File is accessible Date: 04. December 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dimethyl fumarate

The company Biogen Idec GmbH is circulating information on a fatal case of progressive multifocal leukoencephalopathy (PML) in a patient with a severe and long-term lymphopenia treated with Tecfidera®.

Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing bromocriptine: Restrictions of indication regarding inhibition of lactation PDF, 1MB, File is accessible Date: 04. December 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: bromocriptine

The marketing authorisation holders of medicinal products containing bromocriptine are circulating information that bromocriptine should only be taken in strengths up to 2.5 mg per individual dose for prevention or inhibition of lactation …

Information on medicinal products affecting the renin-angiotensin system: Key elements for communication PDF, 42KB, File is accessible Date: 01. December 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ACE-Hemmer, Angiotensin-II-Rezeptor-Antagonisten, Aliskiren

The Pharmacovigilance Risk Assessment Committee (PRAC) has adopted key elements regarding communication of the outcome of the safety review regarding medicinal products that affect the renin-angiotensin system.

Information Letter on Eligard® (leuprorelin acetate depot injection): Risk of lack of efficacy due to incorrect reconstitution and administration PDF, 521KB, File is accessible Date: 28. November 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: leuprorelin acetate

The company Astellas Pharma GmbH is circulating information on a possible lack of clinical efficacy that may occur if the product is reconstituted incorrectly.

Dear Doctor Letter (Rote-Hand-Brief) on Fenistil® 1 mg/ml solution for injection (dimethindene maleate): Quality defects; recall of two batches PDF, 483KB, File is accessible Date: 25. November 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dimethindene maleate

The company Novartis Consumer Health GmbH is sending out information on the recall of batches 11027154 and 11045012 of the medicinal product Fenistil® 1 mg/ml solution for injection as the vials of both batches partially exhibit leakage at the …

Information letter on medicinal products containing codeine as liquid dosage forms by UCB Pharma GmbH: Recall Date: 13. November 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: codein

The company UCB Pharma GmbH is circulating information on the recall of medicinal products containing codeine as liquid dosage forms.