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Dear Doctor Letter (Rote-Hand-Brief) on Mimpara® (cinacalcet): Occurrence of severe hypocalcaemia resulting in death PDF, 338KB, File is accessible Date: 26. March 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: cinacalcet

Important safety-relevant information regarding a fatal case with severe hypocalcaemia in a clinical study in children and adolescents.

Information Letter on NULOJIX® (belatacept): Increased occurrence of acute graft rejection PDF, 113KB, File is accessible Date: 26. March 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: belatacept

The pharmaceutical manufacturer is sending out information on the increased occurrence of acute graft rejection under treatment with NULOJIX® (belatacept) associated with rapid corticosteroid taper in patients at high immunologic risk for …

Dear Doctor Letter (Rote-Hand-Brief) on Fentanyl®-Janssen and Durogesic® SMAT (12, 25, 50, 75, 100 µg/h), transdermal patch (active substance: fentanyl): New warning Date: 11. March 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fentanyl

New warning regarding medicinal products (and generics) containing fentanyl and the possible occurrence of serotonin syndrome if used concomitantly with serotonergic medicines.

Information Letter on NeuroBloc® (botulinum toxin type B): Risks related to "off-label“ use PDF, 848KB, File is accessible Date: 25. February 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: botulinum toxin type B

Serious adverse events were observed in connection with NeuroBloc® if used outside the licensed indication ("off-label“).

Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing tolperisone: Risk of hypersensitivity reactions PDF, 155KB, File is accessible Date: 21. February 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: tolperisone

The pharmaceutical manufacturers are sending out information on the restriction of the indication for medicinal products containing tolperisone and on the risk of hypersensitivity reactions.

Information letter on Optimark® products (gadolinium): New peel-off tracking label PDF, 73KB, File is accessible Date: 21. February 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: gadolinium

In order to enable a better understanding on the use of contrast agents containing gadolinium (Gd-based contrast agents) within the European Union, the European Commission has requested all manufacturers of contrast agents containing …

Dear Doctor Letter (Rote-Hand-Brief) on Xagrid® (active substance: anagrelide hydrochloride): Serious cardiovascular adverse events PDF, 466KB, File is accessible Date: 06. February 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: anagrelide hydrochloride

The pharmaceutical manufacturer is sending out information on a connection between Xagrid® and serious cardiovascular adverse events even in patients without known heart disease. This letter includes a reminder that Xagrid® is only indicated …

Dear Doctor Letter (Rote-Hand-Brief) on Tredaptive® (combination of niacin/laropiprant): Discontinuation of marketing PDF, 584KB, File is accessible Date: 22. January 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: niacin, laropiprant

The pharmaceutical manufacturer is sending out information that due to new data available from a clinical trial the marketing of the medicinal product Tredaptive® has been discontinued and that therefore treatment with this medicinal product …

Dear Doctor Letter (Rote-Hand-Brief) on Pradaxa® (dabigatran etexilate): New contraindication PDF, 337KB, File is accessible Date: 09. January 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dabigatran etexilate

The pharmaceutical manufacturer is sending out information that the medicinal product Pradaxa® is now contraindicated in patients with artificial heart valves who require anticoagulant treatment.

Dear Doctor Letter (Rote-Hand-Brief) on Gilenya® (fingolimod): Recommendations revised in analogy to the recommendations for first use regarding cardiovascular monitoring in case of renewed treatment PDF, 56KB, File is accessible Date: 08. January 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fingolimod

Revised recommendations on repeated cardiovascular monitoring in case of renewed treatment with Gilenya®. These recommendations apply for patients following interruption of treatment and for patients with bradyarrhythmia requiring therapy …

Dear Doctor Letter (Rote-Hand-Brief) on Angiox® (bivalirudin): Inappropriate "bolus-only" dosing for PCI PDF, 235KB, File is accessible Date: 08. January 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: bivalirudin

Communication for healthcare professionals based on reports of IV bolus injections of Angiox® (bivalirudin) alone without immediately following IV infusions. The resulting sub-therapeutic plasma concentrations bear the risk of ineffective …

Dear Doctor Letter (Rote-Hand-Brief) on Tredaptive®: Results of a clinical study PDF, 781KB, File is accessible Date: 02. January 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: niacin, laropiprant

Recommendation not to start new patients on treatment with Tredaptive® as the primary endpoint could not be met in the cardiovascular endpoint study HPS2-THRIVE.

Dear Doctor Letter (Rote-Hand-Brief) on Revlimid® (lenalidomide): Risk of liver diseases PDF, 268KB, File is accessible Date: 10. December 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: lenalidomide

Information for health care professionals regarding the risk of liver diseases in connection with the use of Revlimid® (lenalidomide) in the presence of other risk factors.

Information Letter on Tyverb® (lapatinib): Combination treatment with Tyverb® (lapatinib) less effective in certain settings PDF, 1,010KB, File is accessible Date: 10. December 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: lapatinib

Important information on Tyverb® (lapatinib): Comparative data from clinical trials have shown that in certain settings combination treatments containing lapatinib are less effective than those containing trastzumab (Herceptin®).

Dear Doctor Letter (Rote-Hand-Brief) on Ultravist® (iopromide): Batch recall PDF, 351KB, File is accessible Date: 15. November 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: iopromide

It cannot be ruled out with certainty that the delivered batch 22763A of the medicinal product Ultravist® 300 10x10 ml (PZN 3049076) has been intermixed with Primovist® 10 ml (labelled as Ultravist 30). Therefore, all stocks of this batch are …

Dear Doctor Letter (Rote-Hand-Brief) on Partusisten® intrapartal (fenoterol hydrobromide): Shortage, possible alternative: Partusisten® concentrate for solution for infusion PDF, 107KB, File is accessible Date: 30. October 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fenoterol hydrobromide

Due to a shortage in the supply of Partusisten® intrapartal the company has published information that the medicinal product Partusisten® concentrate for solution for infusion can be used as an alternative. Partusisten® concentrate for …

Dear Doctor Letter (Rote-Hand-Brief) on Caelyx® (pegylated liposomal doxorubicin): Shortage, introduction of a web-based ordering and reservation system PDF, 152KB, File is accessible Date: 30. October 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pegylated liposomal doxorubicin

Supply problems with regard to Caelyx® have been reported in the past. A further letter with information on the reintroduction of Caelyx® is being circulated now. Due to the persisting shortage the company has introduced a web-based ordering …

Agomelatine (Valdoxan®/Thymanax®): Risk of hepatotoxicity PDF, 190KB, File is accessible Date: 25. October 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: agomelatine

Liver function tests are to be performed regularly in patients treated with agomelatine. The medicinal product should be discontinued immediately if an increase in transaminases exceeds 3 times the upper limit of normal or if typical symptoms …

Pegasys® pre-filled syringes (pegylated interferon alfa-2a): Risk of possible shortages PDF, 2MB, File is accessible Date: 04. October 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pegylated interferon alfa-2a

A further information letter states that the risk of possible shortages of Pegasys® pre-filled syringes will persist over longer period of time than originally expected. The company Roche now estimates that the supply situation of the …

Macugen® (pegaptanib sodium): Risk of a serious increase in intraocular pressure due to intravitreal injection of excess volume of Macugen® PDF, 157KB, File is accessible Date: 01. October 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pegaptanib sodium

In order to ensure a safe intravitreal administration of Macugen®, the excess volume must be expelled from the pre-filled syringe before use.