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: Quinapril hydrochloride
Pfizer informs about a precautionary recall of all strengths and pack sizes of the medicinal product Accupro at pharmacy level, as investigations have identified nitrosamine contamination.
Active substance: Quinapril hydrochloride, hydrochlorothiazide
Pfizer informs about a precautionary recall of all strengths and package sizes of the medicinal product Accuzide at pharmacy level, as nitrosamine contamination has been detected by investigations.
Active substance: anagrelide hydrochloride
Shire Pharmaceuticals Ireland Limited (a subsidiary of Takeda Pharmaceuticals Company Limited) would like to inform you that there is an increased risk of thrombotic complications, including cerebral infarction, upon abrupt anagrelide discontinuation.
Active substance: cladribine
Merck Healthcare Germany GmbH provides information about liver damage, including serious cases, reported during treatment of patients with Mavenclad®.
Active substance: levothyroxine sodium
From mid-January 2022, a new formulation of Berlthyrox® will be available under the new trade name L-Thyroxine BC® and with a new package design.
Active substance: irinotecan hydrochloride 3 H2O
Marketing authorization holders of irinotecan-containing drugs inform that UGT1A1 genotyping may be helpful to avoid the risk of neutropenia and diarrhea.
Active substance: donepezil
The marketing authorization holders of donepezil-containing drugs inform that post-marketing cases of QTc interval prolongation and torsade de pointes associated with the use of donepezil have been reported.
Active substance: mitomycineThe Direct Healthcare Professional Communication (DHPC) on restrictions on the use of mitomycin preparations of the company Medac GmbH for intravenous administration has been lifted. The use of a particle filter for intravenous administration is no longer required (see information letter).
Active substance: dapagliflozin
AstraZeneca, in agreement with the European Medicines Agency (EMA) and the German Federal Institute for Drugs and Medical Devices (BfArM), informs that Forxiga® (dapagliflozin) 5 mg is no longer approved for the treatment of patients with type 1 diabetes.
Active substance: varenicline
The company Pfizer Pharma GmbH informs that all Champix (varenicline) batches that were found to contain N-nitroso-varenicline above the acceptable level of intake set at EU level are being recalled.
