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

818 results

Results per page: 10 20 30

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.

Sibutramine containing medicines: implementation of European Commission decision to suspend marketing authorisation due to increased risk of cardiovascular events Date: 04. October 2019 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: sibutramine

On 30 September 2010, the Federal Institute for Drugs and Medical Devices (BfArM) ordered the implementation of the European Commission's decision on drugs containing sibutramine and the increased risk of cardiovascular events. In a letter …

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.

Ranitidine: Recall of ranitidine containing drugs Date: 17. September 2019 Topics: Pharmakovigilanz Type: Risk information

Active substance: Ranitidin

The Federal Institute for Drugs and Medical Devices (BfArM) informs that in the European Union there is a recall of drugs containing the active substance ranitidine produced by the active substance manufacturer Saraca Laboratories Limited.

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.

Gilenya® (Fingolimod): Updated restrictions for use during pregnancy Date: 26. July 2019 Topics: Pharmakovigilanz Type: Risk information

Active substance: fingolimod

The European Medicines Agency (EMA) has recommended that the multiple sclerosis drug Gilenya® (fingolimod) should not be used in pregnant women and women of childbearing potential who do not use effective contraception.

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.

Faecal microbiota transplantation (FMT, stool transplantation): Risk of transmission of multi-resistant bacteria Date: 18. June 2019 Topics: Pharmakovigilanz Type: Risk information

Active substance: FMT

The American Food and Drug Administration (FDA) warns of the risk of serious bacterial infections caused by the transmission of multi-resistant bacteria during faecal microbiota transplants (FMT).

Omega-3 fatty acids: EMA reviewing use after heart attacks Date: 18. June 2019 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: omega-3 fatty acids

The Federal Institute for Drugs and Medical Devices (BfArM) is implementing the implementing decision of the European Commission in its notification of 14 June 2019.

Fenspiride-containing drugs: potential risk of cardiac arrhythmia Date: 06. June 2019 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: fenspirid

The PRAC recommendation was adopted by the CMDh by consensus and will be implemented directly at national level.

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.

Fluoroquinolones: severe and long-lasting side effects in muscles, joints and nervous system Date: 02. May 2019 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: fluoroquinolones | quinolones

In response to enquiries, the BfArM refers at this point to Annex II of the Commission Decision, which describes areas of application in Category 1.

Lapatinib (Tyverb®): Re-analysis of data on use following treatment with trastuzumab Date: 30. April 2019 Topics: Pharmakovigilanz Type: Risk information

Active substance: lapatinib

The European Medicines Agency (EMA) is updating the prescribing information for Tyverb® (lapatinib) after irregularities had been observed in results of a study involving postmenopausal women.

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 (available in German only) PDF, 2MB, File is accessible Date: 10. April 2019 Topics: Pharmakovigilanz Type: Download

Dear Doctor Letter (available in German only)

Information for patients (available in German only) PDF, 2MB, File is accessible Date: 10. April 2019 Topics: Pharmakovigilanz Type: Download

Information for patients (available in German only)

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 …

Metamizole: inconsistent information regarding dosage and contraindications Date: 04. April 2019 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: Metamizol

The European Medicines Agency (EMA) has started a review of medicines containing metamizole.

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.

Xeljanz® (tofacitinib): Increased risk of blood clots in lungs and death with higher dose for rheumatoid arthritis Date: 20. March 2019 Topics: Pharmakovigilanz Type: Risk information

Active substance: tofacitinib

EMA is advising healthcare professionals and patients not to exceed the recommended dose of Xeljanz® (tofacitinib) when treating rheumatoid arthritis.

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.