BfArM - Federal Institute for Drugs and Medical Devices

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iCalcium folinate and 5-fluorouracil: incompatibilities between the injectable forms Date: 21. December 2016 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: calcium folinate | 5-fluorouracil

The BfArM has initiated a graduated plan procedure ("Stufenplanverfahren") in order to update the product informations of medicinal products containing calcium folinate for injection.

Information Letter on Kyprolis® 30 mg vial (carfilzomib): Recall due to possible cracks in the glass of the vials PDF, 29KB, File is accessible Date: 21. December 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: carfilzomib

The company Amgen is circulating information on a voluntary recall of the medicinal product Kyprolis® 30 mg vial.

Recall of the medicinal product Tranexamsäure Carino 100 mg/ml, 5 ml ampoules, 5x5 ml solution for injection, PZN 10816978 batch designation: 013024 due to mix-up with Urapidil-25 mg-Carino ampoules PDF, 18KB, File is accessible Date: 20. December 2016 Topics: Pharmakovigilanz Type: Risk information

Active substance: tranexamic acid

The Federal Institute for Drugs and Medical Devices (BfArM) calls attention to the recall of batch 013024 of the medicinal product Tranexamsäure Carino 100 mg/ml by the company Carinopharm GmbH.

Information letter on Ammonaps® (sodium phenylbutyrate) tablets and granules: Treatment only if no alternative is available
PDF, 422KB, File is accessible
Date: 13. December 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: sodium phenylbutyrate

In view of failings found in the manufacturing site of Ammonaps® (sodium phenylbutyrate) the company Swedish Orphan Biovitrum International AB (Sobi) is circulating information on temporary precautionary measures regarding treatment with …

Injectable allergy medications containing methylprednisolone that include traces of cows' milk proteins: risk of allergic reactions Date: 06. December 2016 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: methylprednisolone

At the request of Croatia, the European Medicines Agency EMA has initiated a review procedure on 1 December 2016. It concerns injectable medicinal products with the active substance methylprednisolone that additionally contain lactose from …

Dear Doctor Letter (Rote-Hand-Brief) on oral solutions containing levetiracetam: Risk of overdosage due to medication errors PDF, 97KB, File is accessible Date: 21. November 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: levetiracetam

In several cases, oral administration of levetiracetam solutions (100 mg/ml) resulted in accidental (up to 10-fold) overdosage, especially in children aged 11 years and younger.

Marketing authorisations based on studies conducted by the company Alkem Laboratories Ltd. in India: suspension of marketing authorisation Date: 14. November 2016 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: Riluzol

In a notice dated 13 October 2016, the Federal Institute for Drugs and Medical Devices (BfArM) ruled the provisional suspension of a generic marketing authorisation that was based on a clinical trial conducted by the company Alkem Laboratories

Information Letter on Erwinase® 10.000 IU/vial, powder for solution for injection: Information on temporary shortages PDF, 38KB, File is accessible Date: 14. November 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Crisantaspase

The company Jazz Pharmaceuticals Germany GmbH is circulating information on the fact that over a period of 4 to 5 weeks there will be temporary shortages as regards new orders of Erwinase®.

Dear Doctor Letter (Rote-Hand-Brief) on Otezla® (apremilast): New important information on suicidal thoughts or behaviour PDF, 713KB, File is accessible Date: 08. November 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: apremilast

The company Celgene GmbH is circulating information regarding occasional cases of suicidal thoughts or behaviour that have been reported from clinical trials and after introduction to the market.

Dear Doctor Letter (Rote-Hand-Brief) on Revlimid® (lenalidomide): New important information on reactivation of virus infections PDF, 335KB, File is accessible Date: 08. November 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: lenalidomide

The company Celgene GmbH is circulating information that cases of virus reactivation after treatment with lenalidomide have been reported.

Information Letter on acitretin and teratogenicity: Extension of the contraception period and the prohibition of blood donation after end of therapy PDF, 98KB, File is accessible Date: 08. November 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: acitretin

In an Information Letter, the companies Dermapharm and Puren Pharma point out the extension of the contraception period and the prohibition of blood donation up to three years after discontinuation of therapy with acitretin.

Metformin for treatment of type 2 diabetes: use is extended to patients with moderately reduced kidney function Date: 03. November 2016 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: metformin

As of 14 October 2016 and based on a European safety review, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended further lowering the limit of the creatinine clearance above which …

Medicinal products containing hydroxyethyl starch (HES): review of the risk-benefit ratio Date: 18. October 2016 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: hydroxyethyl starch

In its notice of 12 October 2016, the BfArM has ruled suspension of the marketing authorisations until 1 November 2017. This notice is not legally enforceable. It is currently permitted to place the medicinal products on the market.

Information letter on emergency hormonal contraceptives (e.g. Postinor®): New recommendations for women taking CYP3A4 inducers PDF, 93KB, File does not meet accessibility standards Date: 26. September 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: levonorgestrel

The company Gedeon Richter Pharma GmbH is circulating new recommendations for women taking liver enzyme inducers. Active substances that trigger such an induction include e.g. preparations containing St. John's wort, rifampicin, certain HIV

3-Bromopyruvate (3-BP): Prescription requirement Date: 14. September 2016 Topics: Pharmakovigilanz Type: Risk information

Active substance: 3-Bromopyruvate

Medicinal products for human use with effects not generally known in medical science only to be dispensed upon prescription by a physician.

Dear Doctor Letter (Rote-Hand-Brief) on GlucaGen® HypoKit (glucagon hydrochloride): Batch recall due to quality defect Date: 07. September 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: glucagon hydrochloride

The company Novo Nordisk Pharma GmbH is circulating information that 3 batches of the GlucaGen® HypoKit are being recalled in Germany.

Renewed information on Erwinase® 10,000 IU/vial (crisantaspase): Shortage and instructions for use for further batches 174aG116 and 177aG116 PDF, 303KB, File is accessible Date: 26. August 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: crisantaspase

In connection with the import of Erwinase® from The United Kingdom, the company Jazz Pharmaceuticals Germany GmbH is circulating information on the fact that a 5 μm filter needle is to be used when administering batches 174aG116 and 177aG116.

Dear Doctor Letter (Rote-Hand-Brief) on Zydelig® (Idelalisib): Updated recommendations following conclusion of the safety data evaluation PDF, 600KB, File is accessible Date: 23. August 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: idelalisib

The company Gilead Sciences GmbH is circulating information on the updated indication of idelalisib as first-line treatment of patients with chronic lymphocytic leukaemia (CLL) and on risk minimisation measures for prevention of infections.

Viread 245 mg and Truvada 200 mg: Counterfeit medicinal products discovered Date: 20. July 2016 Topics: Pharmakovigilanz Type: Risk information

Active substance: tenofovi rdisoproxil, emtricitabine

The Federal Institute for Drugs and Medical Devices (BfArM) warns that counterfeits of the medicinal products Viread 245 mg film-coated tablets and Trudava 200 mg film-coated tablets have been discovered in several European countries.

Arcoxia® (etoricoxib): Altered dosage recommendations for patients with rheumatoid arthritis and ankylosing spondylitis (Bekhterev's disease) PDF, 902KB, File is accessible Date: 19. July 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: etoricoxib

The company MSD is circulating information on altered dosage recommendations for the medicinal product Arcoxia®.

Dear Doctor Letter (Rote-Hand-Brief) on Noxafil® (posaconazole): Tablets and oral suspension are not interchangeable PDF, 784KB, File is accessible Date: 18. July 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: posaconazole

The company MSD is circulating information on the broad-spectrum antimycotic Noxafil® with regard to the use of different pharmaceutical forms.

Zydelig® for treatment of chronic lymphocytic leukaemia and follicular lymphoma: PRAC recommendation Date: 15. July 2016 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: idelalisib

The BfArM issues information on the recommendations of the Pharmacovigilance Risk Assessment Committee (PRAC) for physicians and patients in order to make use of the medicinal product Zydelig® as safe as possible.

Acitretin and teratogenicity: Extension of the period of pregnancy prevention to 3 years after end of treatment Date: 14. July 2016 Topics: Pharmakovigilanz Type: Risk information

Active substance: Acitretin

The BfArM issues information on the result of the European PSUR worksharing procedure for the active substance acitretin. It was determined that the current 2-year period of pregnancy prevention after end of treatment is not sufficient and …

Information letter on Etopophos® 100-/1000 mg (etoposide): Shortage and procedure for ordering PDF, 146KB, File is accessible Date: 14. July 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: etoposide

The company Bristol-Myers Squibb GmbH & Co. KGaA is circulating information regarding the shortage of Etopophos® 100-/1000 mg.

Dear Doctor Letter (Rote-Hand-Brief) on Adempas® (riociguat): New contraindication for patients with pulmonary hypertension in connection with idiopathic interstitial pneumonia (PH-IIP) PDF, 900KB, File is accessible Date: 05. July 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: riociguat

In coordination with the European Medicines Agency the companies Bayer and MSD are circulating a Dear Doctor Letter on Adempas® with information regarding preliminary results of the RISE-IIP study.

Implanon NXT®: Possible risks and complications associated with insertion, localisation, removal and migration PDF, 1MB, File does not meet accessibility standards Date: 27. June 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: etonogestrel

The company MSD Sharp & Dohme GmbH recommends that only those physicians should insert and remove Implanon NXT® who have completed training for the use of the NXT® applicator and techniques for insertion and removal of the Implanon NXT® …

Dear Doctor Letter (Rote-Hand-Brief) on Thalidomide Celgene®: New important information on virus reactivation and pulmonary hypertension PDF, 504KB, File is accessible Date: 21. June 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: thalidomide

The company Celgene GmbH is circulating information on cases of virus reactivation and pulmonary hypertension under treatment with thalidomide.

Cialis®: Counterfeit medicinal products discovered in Greece Date: 10. June 2016 Topics: Pharmakovigilanz Type: Risk information

Active substance: tadalafil

The Federal Institute for Drugs and Medical Devices (BfArM) calls attention to cases of counterfeits from Greece of Cialis 20 mg film-coated tablets for treatment of erectile dysfunction. This concerns packages with the lot numbers C334146 and …

Renewed Information Letter on Erwinase® 10,000 IU/vial (crisantaspase): Shortage and instructions for use for the additional batch 177G* PDF, 400KB, File does not meet accessibility standards Date: 02. June 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: crisantaspase

The company Jazz Pharmaceuticals Germany GmbH is circulating information on use and handling instructions (visual inspection and filtering) of the Erwinase batch 177G* imported from the United Kingdom.

Information Letter on Erwinase® 10,000 IU/vial (crisantaspase): Instructions for use and shortage PDF, 139KB, File does not meet accessibility standards Date: 02. June 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: crisantaspase

The company Jazz Pharmaceuticals Germany GmbH is circulating information on use and handling instructions (visual inspection and filtering) of the Erwinase batch 174G imported from the United Kingdom.