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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.