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 …