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Dear Doctor Letter (Rote-Hand-Brief) on cyproterone acetate 2 mg/ethinylestradiol 35 µg PDF, 292KB, File is accessible Date: 12. June 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: cyproterone acetate

Strengthening of warnings, new contraindications and updated indication.

Information Letter on CILEST® and PRAMINO® tablets: Recall of the entire stock from the market PDF, 337KB, File is accessible Date: 04. June 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ethinyl estradiol, norgestimate

The pharmaceutical manufacturer is sending out information on the recall of the entire stock of CILEST® and PRAMINO® from the market as both products are no longer available.

Dear Doctor Letter (Rote-Hand-Brief) on Samsca® (tolvaptan): liver injury PDF, 188KB, File is accessible Date: 23. May 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: tolvaptan

Information for healthcare professionals regarding the potential risk of liver injury due to Samsca® (tolvaptan).

Information Letter on Nipruss® (sodium nitroprusside): recall all batches PDF, 944KB, File is accessible Date: 23. May 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: sodium nitroprusside

As a precautionary measure and in co-ordination with the competent supervising authority, the company UCB Pharma GmbH is recalling all batches of Nipruss® dry substance for infusion after reconstitution (PZN 04746699).

Dear Doctor Letter (Rote-Hand-Brief) on Protelos® (strontium ranelate): Restriction of indication PDF, 301KB, File is accessible Date: 13. May 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: strontium ranelate

Recent data showing an increased risk of myocardial infarction have resulted in restrictions regarding the use of Protelos® (restricted indication, new contraindications and warnings).

Dear Doctor Letter (Rote-Hand-Brief) on Pletal® (cilostazol): New safety information PDF, 3MB, File is accessible Date: 02. May 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: cilostazol

As the result of a review of the benefits and risks of cilostazol and in collaboration with the European Medicines Agency, the indications for medicinal products containing cilostazol have been restricted.

Dear Doctor Letter (Rote-Hand-Brief) on Tavor® pro injectione 2 mg solution for injection (lorazepam): Recall PDF, 119KB, File is accessible Date: 02. May 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: lorazepam

Recall of Tavor® pro injectione 2 mg solution for injection due to possible contamination with glass splinters.

Increlex® 10 mg/ml solution for injection (mecasermin, recombinant human IGF-1): Temporary market shortage PDF, 208KB, File is accessible Date: 30. April 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: mecasermin, recombinant human IGF-1

The company Ipsen Pharma GmbH is sending out information that the medicinal product Increlex® 10 mg/ml solution for injection will presumably be out of stock starting early August 2013. This shortage is due to manufacturing difficulties and …

Information Letter on CAELYX®: As of Monday 29 April 2013, supply with the medicinal product will return to normal PDF, 408KB, File is accessible Date: 23. April 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pegylated liposomal doxorubicin

Janssen-Cilag is sending out information that the supply with CAELYX® 2 mg/ml concentrate for solution for infusion is returning to regular availability and that the "CAELYX® Managed Access Programme" is being terminated.

Dear Doctor Letter (Rote-Hand-Brief) on Thalidomide Celgene™ (thalidomide): Risk of second primary haematological malignancies PDF, 288KB, File is accessible Date: 08. April 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: thalidomide

The pharmaceutical manufacturer is sending out information on the risk of second primary haematological malignancies in patients treated with thalidomide.

Dear Doctor Letter (Rote-Hand-Brief) on INCIVO® (telaprevir): Occurrence of serious skin reactions PDF, 351KB, File is accessible Date: 08. April 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: telaprevir

The pharmaceutical manufacturer is sending out information on the occurrence of serious skin reactions associated with treatment with INCIVO®.

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 …

Pharmacovigilance Risk Assessment Committee (PRAC) Date: 19. January 2013 Topics: Arzneimittelsicherheit Pharmakovigilanz Type: Article

The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee is responsible for assessing and monitoring safety issues for human medicines; it is the successor to the Pharmacovigilance Working Party (PhVWP) of the Committee for …

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.

Tredaptive®, Pelzont®, Trevaclyn® (niacin/laropiprant): start of a review procedure in accordance with Article 20 of Regulation (EC) No. 726/2004 Date: 02. January 2013 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: niacin | laropiprant

The European Medicines Agency (EMA) has initiated a review procedure regarding the lipid-lowering drugs Tredaptive®/Pelzont®/Trevaclyn® after the MAH of the medicinal products had published preliminary results of a large, long-term study.

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 …

Diphenhydramine, doxylamine and dimenhydrinate: Over-the-counter first-generation H1-antihistamines in infants and young children Date: 09. November 2012 Topics: Pharmakovigilanz Type: Risk information

Active substance: diphenhydramine, doxylamine and dimenhydrinate

Children under the age of 3 years are especially at risk of experiencing adverse effects of first-generation H1-antihistamines. The BfArM points out that these medicinal products are only to be administered to infants and young children under …

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 …