BfArM - Federal Institute for Drugs and Medical Devices

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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.

Dear Doctor Letter (Rote-Hand-Brief) on hormonal contraceptives: new warning regarding suicidal tendencies possibly linked to depression associated with use of hormonal contraception PDF, 2MB, File is accessible Date: 21. January 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Hormonelle Kontrazeptiva

The marketing authorisation holders of hormonal contraceptives are issuing information on the inclusion of a new warning on suicidal tendencies possibly linked to depression.

Dear Doctor Letter (Rote-Hand-Brief) on Sodium-Glucose-Co-Transporter 2 inhibitors (SGLT2i): risk of Fournier´s gangrene (necrotising fasciitis of the perineum) PDF, 965KB, File is accessible Date: 21. January 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: SGLT2 inhibitors

The Marketing Authorisation Holders (MAH) inform about the risk of Fournier´s gangrene (necrotising fasciitis of the perineum) associated with the use of SGLT2 inhibitors.

Dear Doctor Letter (Rote-Hand-Brief) for contraceptives containing dienogest and ethinylestradiol: risk of venous thromboembolism PDF, 239KB, File is accessible Date: 11. December 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dienogest, ethinylestradiol

The company Jenapharm GmbH & Co. KG provides information on the risk of venous thromboembolism (VTE) in women using contraceptives containing dienogest and ethinylestradiol compared to women using levonorgestrel and ethinylestradiol …

Information Letter on Palexia® 20 mg/ml oral solution (tapentadol): administration to children and adolescents in hospitals PDF, 1MB, File does not meet accessibility standards Date: 06. December 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: tapentadol

The company Grünenthal is circulating information on a new dosing pipette for weight-based dosing in children with a body weight of more than 16 kg.

Risk information for Colchicum-Dispert® and Colchysat®Bürger by the company Bürger Date: 20. November 2018 Topics: Pharmakovigilanz Type: Risk information

Active substance: Colchicin

Based on reports of overdosage leading to death, the dosing recommendations and warnings have been updated.

Suicidal tendencies possibly linked to depression associated with use of hormonal contraception Date: 15. November 2018 Topics: Pharmakovigilanz Type: Risk information

Active substance: hormonal contraceptives

As a result of a signal procedure on the risk of suicidal tendencies in connection with the use of hormonal contraceptives, a new warning is to be included in the Summary of Product Characteristics and Patient Information Leaflet.

Dear Doctor Letter (Rote-Hand-Brief) on Valproat: new restrictions on use; pregnancy prevention program to be put in place PDF, 173KB, File is accessible Date: 09. November 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: valproate

Marketing authorization holders of valproate-containing drugs inform about important new contraindications, strengthened warnings and measures to prevent valproate exposure during pregnancy.

Dear Doctor Letter (Rote-Hand-Brief) on systemic and inhaled fluoroquinolones: risk of aortic aneurysm and dissection PDF, 2MB, File is accessible Date: 26. October 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fluoroquinolones

The marketing authorisation holders of fluoroquinolone-containing medicinal products would like to inform about a new warning regarding the risk of aortic aneurysm and dissection associated with the use of systemic or inhaled fluoroquinolones.

Dear Doctor Letter (Rote-Hand-Brief) on hydrochlorothiazide: risk of non-melanoma skin cancer (basal cell carcinoma, squamous cell carcinoma) PDF, 3MB, File is accessible Date: 17. October 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: hydrochlorothiazide

Marketing authorisation holders of the products containing hydrochlorothiazide would like to inform about pharmacoepidemiological studies which have shown a risk of non-melanoma skin cancer with exposure to increasing cumulative doses of …

Dear Doctor Letter (Rote-Hand-Brief) on Sildenafil (Revatio® and Viagra®): should not be used to treat intrauterine growth restriction PDF, 165KB, File is accessible Date: 11. October 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: sildenafil

The STRIDER clinical trial, which was studying sildenafil for treating intrauterine growth restriction (IUGR), has been prematurely discontinued due to a higher incidence of persistent pulmonary hypertension of the newborn (PPHN) and overall …

Dear Doctor Letter (Rote-Hand-Brief) on Rivaroxaban (Xarelto®): increase in all-cause mortality, thromboembolic and bleeding events in patients after transcatheter aortic valve replacement in a prematurely stopped clinical trial PDF, 163KB, File is accessible Date: 02. October 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: rivaroxaban

A phase III clinical study, 17938 (GALILEO), conducted in patients after transcatheter aortic valve replacement (TAVR) has been terminated ahead of schedule based on preliminary results showing an increase in all-cause mortality, …

Dear Doctor Letter (Rote-Hand-Brief) on hydroxyethyl starch (HES) solutions for infusion: new measures to reinforce existing restrictions due to increased risk of renal dysfunction and mortality in critically ill or septic patients PDF, 231KB, File is accessible Date: 13. August 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: hydroxyethyl stark, HES

The marketing authorisation holders inform that hydroxyethyl starch (HES)-containing solutions for infusion have continued to be used in patients with contraindications. Such contraindicated use is associated with a risk for serious harm, …

Risk Management Plans (RMP) Date: 13. August 2018 Topics: Pharmakovigilanz Type: Article

Submission of Risk Management Plans (RMP) within the Framework of Regulatory Actions (Marketing authorization applications, Renewals and Variations)

Dear Doctor Letter (Rote-Hand-Brief) on radium-223-dichloride (Xofigo): new restrictions due to increased risk of fractures and possible increased risk of death PDF, 139KB, File is accessible Date: 06. August 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Radium-223-dichlorid

The use of Xofigo is associated with an increased risk of fractures. A possible increased risk of death was also observed in a clinical trial investigating radium-223 dichloride (Xofigo) in combination with abiraterone acetate and …

Esmya® (ulipristal acetate) for treatment of uterine fibroids: risk of serious liver injury Date: 03. August 2018 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: ulipristal acetate

The European risk assessment procedure for Esmya® has been completed following the EU Commission's decision.

Dear Doctor Letter (Rote-Hand-Brief) on ulipristal acetate (Esmya®): restricted indication, new contraindication and requirements for liver monitoring PDF, 430KB, File is accessible Date: 03. August 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Ulipristalacetat

Restricted indication, new contraindication and requirements for liver monitoring.

Dear Doctor Letter (Rote-Hand-Brief) on Spinraza (nusinersen): communicating hydrocephalus not related to meningitis or bleeding reported PDF, 306KB, File is accessible Date: 31. July 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: nusinersen

The marketing authorization holder, Biogen, informs of the occurrence of communicating hydrocephalus not related to meningitis or bleeding under treatment with Spinraza. Biogen informs on several measures that should be followed.

Information Letter on Fiasp® (insulin aspart): new colour scheme for cartridges and pre-filled pens PDF, 291KB, File is accessible Date: 06. July 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: insulin aspart

The company Novo Nordisk Pharma GmbH is circulating information on the fact that a new colour scheme will be introduced for Fiasp® products as of July 2018 in order to improve their discernibility from Tresiba®.

Dear Doctor Letter (Rote-Hand-Brief) on finasteride: risk of sexual dysfunction and psychiatric symptoms PDF, 2MB, File is accessible Date: 05. July 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: finasterid

Marketing Authorization Holders are circulating information on the risk of developing sexual dysfunctions and psychiatric symptoms under treatment with finasteride.

Dear Doctor Letter (Rote-Hand-Brief) on darunavir/cobicistat: increased risk of therapeutic failure and mother-to-child transmission of HIV PDF, 588KB, File is accessible Date: 25. June 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: darunavir, cobicistat

The company Janssen-Cilag GmbH is circulating information on the fact that treatment with darunavir/cobicistat should not be initiated during pregnancy.

Dear Doctor Letter (Rote-Hand-Brief) on filgrastim, pegfilgrastim, lipegfilgrastim and lenograstim: new warnings regarding aortitis associated with the use of granulocyte colony-stimulating factors (G-CSF) PDF, 444KB, File is accessible Date: 25. June 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: filgrastim, pegfilgrastim, lipegfilgrastim, lenograstim

In agreement with the Federal Institute for Drugs and Medical Devices (BFARM), the marketing authorisation holders are circulating information on the risk of aortitis associated with the administration of granulocyte colony-stimulating factors …

Information Letter on Actilyse® powder and solvent for solution for injection and infusion (alteplase) for acute ischaemic stroke: important extension of indication to include adolescents under 16 years of age PDF, 330KB, File is accessible Date: 22. June 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: alteplase

Actilyse® has been licensed for treatment of acute ischaemic stroke in adolescent patients under 16 years of age.

Dear Doctor Letter (Rote-Hand-Brief) on Maxipime® (cefepime): risk of serious neurologic adverse events in patients with renal impairment PDF, 178KB, File is accessible Date: 18. June 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: cefepime

Information is circulated on the risk of serious adverse events, including encephalopathy, in patients with renal impairment who received doses that exceeded the recommendations.

Dear Doctor Letter (Rote-Hand-Brief) on certain intravenous fluids containing electrolytes and/or carbohydrates: risk of severe hyponatraemia PDF, 452KB, File is accessible Date: 07. June 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: electrolytes, carbohydrates

In agreement with the BfArM, the pharmaceutical entrepreneurs are circulating information on the risk of irreversible brain injury.

Notification of the Stufenplanbeauftragter rtf, 265KB, File does not meet accessibility standards Date: 06. June 2018 Topics: Pharmakovigilanz Type: Form

According to § 63a subparagraph 3 of the German Medicines Act (AMG), pharmaceutical entrepreneurs are obligated to notify a Stufenplanbeauftragter to the competent authority, the responsible regional authority and, if necessary, also to the …

Notification of a change to the Stufenplanbeauftragter rtf, 299KB, File does not meet accessibility standards Date: 06. June 2018 Topics: Pharmakovigilanz Type: Form

In addition to the obligation to notify a Stufenplanbeauftragter (officer/commissioner of the graduated plan), an alteration or change of the Stufenplanbeauftragter must also be notified. The procedure of notification of a change is identical to the …

Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing dolutegravir (Tivicay®, Triumeq®, Juluca®): neural tube defects in babies whose mothers became pregnant while taking dolutegravir PDF, 510KB, File is accessible Date: 04. June 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dolutegravir

There are reports from an observational study on neural tube defects in babies, whose mothers became pregnant while taking dolutegravir.

Information Letter on flupirtine: recall and revocation of marketing authorisation PDF, 36KB, File is accessible Date: 04. June 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: flupirtine

Following the European benefit-risk assessment, marketing authorisations of medicinal products containing the active substance flupirtine are revoked on an EU-wide level due to the risk of liver damage.

Dear Doctor Letter (Rote-Hand-Brief) on Lynparza® (olaparib): risk of medication errors due to new dosage forms PDF, 552KB, File is accessible Date: 29. May 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: olaparib

Lynparza® capsules and Lynparza® tablets must neither be substituted 1:1 nor on a milligramme-to-milligramme basis.