BfArM - Federal Institute for Drugs and Medical Devices

Navigation and service

Search i

Search help

  • Enter one or more search terms in the search field. Upper and lower case are not relevant.
  • As soon as you have entered three letters in the search field, various search words will be suggested from which you can choose one.
  • If you are searching for a certain group of words, put these words in double quotes. The hits will then contain the words in the order you entered, e.g. "medicines for children".
  • Multiple search terms can also be combined with the Boolean operators AND and OR. When using the operator AND, the results contain the intersection of all search terms. When using the operator OR, the hits contain one of the search terms or only individual search terms. The result set is therefore significantly larger. Please note that these operators must be written in capital letters.

  • If you receive a (too) large number of hits as a result of your search, you can narrow it down by using filters. These filter options appear to the left of the search results and are subdivided into:

    • category (e.g. safety of medicinal products, medical devices, code systems)
    • format (e.g. download, risk information, DHPCs)
    • time interval (e.g. last 30 days, older than ...)
  • Selected filters can be removed individually or all at once ("Show all results").
  • By default, search results are sorted by relevance, but they can also be sorted chronologically ("Latest entries first" or "Oldest entries first").

Enter search term

447 results

Filter

Results per page: 10 20 30

Sorting:

Latest entries first

Relevance

Latest entries first(selected sorting)

Oldest entries first

Selected filter

Direct Healthcare Professional Communication (DHPC) on cyproterone acetate: restrictions in use due to the risk of meningioma PDF, 723KB, File is accessible Date: 16. April 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Cyproteronacetat

The marketing authorisation holders of cyproterone containing medicines would like to inform about the occurrence of meningiomas in association with the use of cyproterone acetate.

Information Letter on Zomacton® (somatropin): change in the trade names of the injection equipment for administering the drugs PDF, 192KB, File is accessible Date: 16. April 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: somatropin

Ferring Arzneimittel GmbH informs that the needle-free injection device ZomaJet 2 Vision for the administration of Zomacton® 4 mg has been renamed ZomaJet 4 and the needle-free injection device ZomaJet Vision X for the administration of …

Direct Healthcare Professional Communication (DHPC) on Trisenox® (arsenic trioxide): risk of medication errors due to the introduction of a 2 mg/ml vial replacing the 1 mg/ml glass vial PDF, 239KB, File is accessible Date: 31. March 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: arsenic trioxide

The company Teva B.B. informs in coordination with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) that the Trisenox® (arsenic trioxide) 1 mg/ml 10 ml ampoule (contains 10 mg arsenic …

Direct Healthcare Professional Communication (DHPC) on ulipristal acetate 5 mg for uterine fibroids: not to be used during ongoing review of liver injury risk PDF, 255KB, File is accessible Date: 23. March 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ulipristal acetate

Gedeon Richter Pharma GmbH in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) informs that Ulipristal acetate 5 mg is temporarily withdrawn from the market during the ongoing …

Direct Healthcare Professional Communication (DHPC) on Xeljanz® (Tofacitinib): increased risk of venous thromboembolic events and increased risk of serious and fatal infections PDF, 337KB, File is accessible Date: 20. March 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: tofacitinib

Pfizer, in coordination with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM), informs that a dose-dependent increased risk of serious venous thromboembolic events has been observed in …

Direct Healthcare Professional Communication (DHPC) on Cytotec® (misoprostol): risks associated with an off-label use for birth initiation PDF, 235KB, File is accessible Date: 16. March 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Misoprostol

The German Federal Institute for Drugs and Medical Devices (BfArM) informs that there are numerous new reports of severe side effects when using Cytotec® outside the approved indication. The drug Cytotec® is not approved for birth initiation.

…

Information Letter on valproate: restrictions on use and introduction of the contraceptive programme PDF, 821KB, File is accessible Date: 26. February 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: valproate

The marketing authorisation holders Aristo Pharma GmbH, Desitin Arzneimittel GmbH and Sanofi-Aventis Deutschland GmbH will again provide information about restrictions on use and the introduction of the pregnancy prevention programme for …

Direct Healthcare Professional Communication (DHPC) on Linoladiol N® (Estradiol): risks associated with systemic exposure PDF, 701KB, File is accessible Date: 20. February 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: estradiol

Dr. August Wolff GmbH & Co. KG Arzneimittel in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) informs that treatment with Linoladiol N® (containing estradiol 100 …

Direct Healthcare Professional Communication (DHPC) on▼Picato® (ingenol mebutate): suspension of the marketing authorisation due to risk of skin malignancy PDF, 116KB, File does not meet accessibility standards Date: 27. January 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ingenol mebutate

LEO Pharma would like to inform you about the suspension of the marketing authorisation of Picato (ingenol mebutate) as a precautionary measure due to growing concerns on the possible risk of skin malignancy.

Direct Healthcare Professional Communication (DHPC) on Implanon NXT® - Etonogestrel 68 mg for subcutaneous use: updated instructions for inserting and removing the implant PDF, 188KB, File is accessible Date: 15. January 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: etonogestrel

In consultation with the Federal Institute for Drugs and Medical Devices (BfArM), MSD Sharp & Dohme GmbH informs that the instructions for inserting and removing the implant have been updated to further minimize the risk of neurovascular …

Dear Doctor Letter (Rote-Hand-Brief) on ▼Increlex® (Mecasermin): risk of benign and malignant neoplasia PDF, 173KB, File is accessible Date: 02. December 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Mecasermin

Ipsen Pharma provides information on cases of benign and malignant neoplasia in children and adolescents treated with Increlex® after the launch of Mecasermin.

Dear Doctor Letter (Rote-Hand-Brief) on methotrexate: new measures to avoid potentially fatal dosage errors with methotrexate in autoimmune diseases PDF, 79KB, File is accessible Date: 25. November 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: methotrexate

Marketing authorisation holders of medicinal products containing methotrexate would like to inform you about new measures to avoid potentially fatal dosage errors.

Dear Doctor Letter (Rote-Hand-Brief) on ondansetron: increased risk of orofacial malformations when used in the first trimester of pregnancy PDF, 79KB, File is accessible Date: 01. October 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ondansetron

In coordination with the Federal Institute for Drugs and Medical Devices (BfArM), the marketing authorisation holders of drugs containing ondansetron inform about new findings in connection with the use of ondansetron during pregnancy.

Dear Doctor Letter (Rote-Hand-Brief) on ▼Picato® (ingenol mebutate): caution when treating patients with a history of skin cancer PDF, 166KB, File is accessible Date: 23. September 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Ingenolmebutat

The pharmaceutical entrepreneur LEO Pharma informs about cases of squamous cell carcinoma in patients treated with inngenolmebutate.

Dear Doctor Lettter (Rote-Hand-Brief) on retinoids: teratogenicity and neuropsychiatric diseases Date: 09. September 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: acitretin | adapalene | alitretinoin | bexaroten | isotretinoin | tazarotene | tretinoin

Marketing authorisation holders of medicinal products containing retinoids shall provide information on updates on teratogenicity and neuropsychiatric diseases.

Dear Doctor Letter (Rote-Hand-Brief) on ▼Fingolimod (Gilenya®): new contraindication in pregnant women and in women of childbearing potential not using effective contraception PDF, 1MB, File is accessible Date: 02. September 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fingolimod

Novartis would like to inform you of the new contraindication of fingolimod (Gilenya) in pregnant women and women of childbearing potential not using effective contraception due to the risk of congenital malformations in fetuse.

Dear Doctor Letter (Rote-Hand-Brief) on elmiron® (pentosan polysulfate sodium): risk of pigmentary maculopathy PDF, 40KB, File is accessible Date: 18. July 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pentosan polysulfate sodium

The pharmaceutical company bene-Arzneimittel GmbH provides information on rare cases of pigmentary maculopathy using pentosan polysulfate sodium.

Dear Doctor Letter (Rote-Hand-Brief) on Adenuric® (febuxostat): increased risk of cardiovascular death and all-cause mortality in patients treated with febuxostat in the CARES study PDF, 604KB, File is accessible Date: 27. June 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Febuxostat

Marketing authorisation holders report significantly increased all-cause mortality in patients treated with Febuxostat in the CARES study.

Dear Doctor Letter (Rote-Hand-Brief) on Xeljanz® (tofacitinib): restriction of 10 mg twice-daily use in patients who are at high risk for pulmonary embolism PDF, 294KB, File is accessible Date: 28. May 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: tofacitinib

Pfizer Europe would like to inform you that the European Medicines Agency (EMA) is reviewing the benefits and risks of Xeljanz® (tofacitinib) in all authorised indications.

Dear Doctor Letter (Rote-Hand-Brief) on Eliquis®, Pradaxa®, Lixiana®/Roteas® and Xarelto®: use is not recommended in patients with antiphospholipid syndrome PDF, 1MB, File is accessible Date: 23. May 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: apixaban | dabigatran etexilate | edoxaban | rivaroxaban

Marketing authorisation holders inform that the use of direct oral anticoagulants (DOACs) in patients with antiphospholipid syndrome is not recommended.

Dear Doctor Letter (Rote-Hand-Brief) on Tyverb® (lapatinib): important update to Summary of Product Characteristics PDF, 872KB, File is accessible Date: 17. May 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Lapatinib

Novartis will provide information on changes with regard to the therapeutic indication (Section 4.1) of the Lapatinib Summary of Product Characteristics.

Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing biotin: risk of false laboratory test results due to biotin interferences PDF, 213KB, File is accessible Date: 15. May 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: biotin

Taking medicinal products, dietary supplements or dietary food for special medical purposes is associated with a risk of false positive or false negative laboratory test results.

Dear Doctor Letter (Rote-Hand-Brief) on modafinil: potential risk of severe congenital malformations PDF, 762KB, File is accessible Date: 09. May 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: modafinil

In coordination with the Federal Institute for Drugs and Medical Devices (BfArM), the marketing authorisation holders of medicinal products containing modafinil inform about new findings related to the use of modafinil during pregnancy.

Dear Doctor Letter (Rote-Hand-Brief) on domperidone: reminder regarding measures to minimise cardiac risks PDF, 1MB, File is accessible Date: 29. April 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: domperidone

In agreement with the Federal Institute for Drugs and Medical Devices (BfArM), the marketing authorisation holders of medicinal products containing domperidone would like to remind you of the safety measures from the year 2014.

Dear Doctor Letter (Rote-Hand-Brief) on Euthyrox® (levothyroxine) new formulation tablets: monitoring of patients switching between tablets Date: 10. April 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: levothyroxine

Merck Serono GmbH would like to inform you in agreement with the Federal Institute for Drugs and Medical Devices that a new formulation of Euthyrox® (levothyroxine) tablets will be available End of April/Beginning of May 2019.

Dear Doctor Letter (Rote-Hand-Brief) on fluoroquinolone antibiotics: serious and long-lasting, disabling and potentially permanent side effects PDF, 2MB, File is accessible Date: 08. April 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fluoroquinolones

The marketing authorisation holders of medicinal products containing fluoroquinolone are circulating information on the incidence of serious and potentially permanent side effects associated with fluoroquinolones administered systemically or …

Dear Doctor Letter (Rote-Hand-Brief) on Xeljanz® (tofacitinib): increased risk of pulmonary embolism and mortality in patients with rheumatoid arthritis PDF, 277KB, File is accessible Date: 29. March 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: tofacitinib

Pfizer Pharma would like to inform you that the recommended dose of Xeljanz® (active ingredient: tofacitinib) for the treatment of rheumatoid arthritis must not be exceeded.

Dear Doctor Letter (Rote-Hand-Brief) on Genvoya®, Stribild® und Tybost®: increased risk of treatment failure and increased risk of mother-to-child transmission of HIV infection PDF, 815KB, File is accessible Date: 26. March 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: elvitegravir | cobicistat

Gilead Sciences informs that treatment with elvitegravir- and cobicistat-containing drugs should not be started during pregnancy.

Information Letter on Dantrolene 20 mg powder for solution for injection (DANTRIUM IV): use filtration device provided with product to reduce risk of injection site reactions PDF, 373KB, File is accessible Date: 01. March 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Dantrolen

The company Norgine informs on a new filtration device (BBraun Mini-Spike) to reduce the risk of reactions at the injection site.

Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing carbimazole or thiamazole: risk of acute pancreatitis and strengthened advice on contraception PDF, 2MB, File does not meet accessibility standards Date: 06. February 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: carbimazole, thiamazole

Marketing authorisation holders provide information on the need for effective contraception in women of childbearing age and on the risk of acute pancreatitis.