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

Results per page: 10 20 30

Selected filter

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.