BfArM - Federal Institute for Drugs and Medical Devices

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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.