BfArM - Federal Institute for Drugs and Medical Devices

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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.

Medicinal products containing ambroxol and bromhexine: recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) and the Co-ordination group (CMDh) within a European safety review concerning the risk of hypersensitivity reactions Date: 10. March 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: ambroxol | bromhexine

The BfArM issues information on a recommendation by the PRAC and the resulting majority decision by the Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) within a European safety review in accordance with …

Neulasta®: Possibility of counterfeits being on the market Date: 06. March 2015 Topics: Pharmakovigilanz Type: Risk information

Active substance: pegfilgrastim

The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) has received information via the "Land" authority ("Landesbehörde") of Bavaria and via the EU's Rapid Alert System (RAS) that …

Cialis®: Counterfeit medicinal products from Italy - Update Date: 24. February 2015 Topics: Pharmakovigilanz Type: Risk information

Active substance: tadalafil

The BfArM is reporting further information from the company Lilly as the marketing authorisation holder of the originator product.

Information on theft of the medicinal product Sildaristo® produced by Aristo Pharma GmbH in Berlin Date: 12. February 2015 Topics: Pharmakovigilanz Type: Risk information

Active substance: sildenafil

The State Office of Health and Social Affairs in Berlin ("Landesamt für Gesundheit und Soziales", LaGeSo) has informed the BfArM of the theft of the medicinal product Sildaristo®.

Polymyxin-based products (colistin, colistimethate sodium): realisation of the EU Commission's implementing decision Date: 30. January 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: colistin | colistimethate sodium

Based on the review of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), the European Commission decided on 16 December 2014 to update the product informations of medicinal products containing …

Medicinal products containing testosterone: review of possible cardiac risks Date: 22. January 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: testosterone

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has reviewed the risk of cardiovascular diseases, particularly heart attacks, under treatment with testosterone.

Medicinal products containing ponatinib (Iclusig®): risk of blood vessel blockage Date: 15. January 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: Ponatinib

With the publication of the decision of the European Commission on 15 January 2015, the risk assessment procedure for Iclusig® was completed.

Medicinal products containing valproate and related substances: risk of anomalies in neonates Date: 13. January 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: valproate

On 19 November 2014, the Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) decided unanimously based on the recommendations of the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment …

Medicinal products containing Estradiol for topical administration: realisation of the EU Commission's implementing decision Date: 09. January 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: estradiol

In its notice of 9 January 2015, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the realisation of the corresponding implementing decision of the EU Commission C(2014)6030 of 19 August 2014