BfArM - Federal Institute for Drugs and Medical Devices
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If you use the services of this provider, it is possible that usage data will be collected and, if necessary, stored in server logs.The BfArM has no influence on the type and scope of the transmitted or stored data. Go to LinkedIn
DHPCs (Rote-Hand-Briefe) and Information Letters
Here you will find Direct Healthcare Professional Communications - DHPCs (so-called "Rote-Hand-Briefe") and Information Letters sent out by pharmaceutical companies informing healthcare professionals about newly identified major drug-associated risks and measures to reduce them. The files are available in German only. The information published here only applies to drugs which are in the BfArM's responsibility.
"Rote-Hand-Briefe" and further safety information for vaccines and biomedical medicinal products published by the Paul-Ehrlich-Institute can be found at: Rote-Hand-Briefe (PEI).
After clicking on the "search all DHPCs and Information letters" button, the total amount of all DHPCs and Information letters can be searched in the website search.
Active substance: electrolytes, carbohydrates
In agreement with the BfArM, the pharmaceutical entrepreneurs are circulating information on the risk of irreversible brain injury.
Active substance: dolutegravir
There are reports from an observational study on neural tube defects in babies, whose mothers became pregnant while taking dolutegravir.
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.
Active substance: azithromycin
The clinical trial ALLOZITHRO on the prevention of bronchiolitis obliterans syndrome (BOS) in patients after allogeneic haematopoietic stem cell transplantation (HSCT) was discontinued prematurely.
Active substance: enoxaparin sodium
The company Techdow Pharma Germany GmbH is circulating information on rare cases of premature self-activation of the safety device in unopened, unused pre-filled Inhixa syringes.
Active substance: radium 223 dichloride
The company Bayer AG issues information that an interim analysis of the randomised clinical trial in patients with castration-resistant metastatic prostate cancer has shown an increased risk of deaths and fractures in patients receiving radium 223 dichloride (Xofigo®) in combination with abiraterone acetate (Zytiga®) and prednisone/prednisolone.
Active substance: sonidegib
Medicinal products containing sonidegib are embryotoxic and/or teratogenic and can cause embryo-foetal death or severe birth defects when administered to pregnant women; therefore, Odomzo® must not be taken during pregnancy.
Active substance: Sonidegib
Active substance: Ulipristal acetate
After reports of serious liver damage, including acute liver failure, in patients treated with Esmya® temporary measures have been taken.
Active substance: obeticholic acid
Due to the risk of serious liver injury in patients with moderate and severe hepatic impairment, all patients are to be monitored by way of laboratory and clinical assessment for progression of the PBC disease during treatment with obeticholic acid in order to determine whether dosage adjustment is needed.
