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: angiotensin II
The company Paion Deutschland GmbH informs that in several hospitals in the USA vials of the medicinal product Giapreza have been detected that are not filled with the required volume.
Active substance: disodium folinate
The company medac GmbH informs that during the ongoing stability program visible particles have been found in the medicinal product Oncofolic 50 mg/ml solution for injection/infusion.
Active substance: L-arginine hydrochloride
The company B. Braun Melsungen AG informs that visible particles have been found in the retained samples of several batches of the medicinal product L-Arginine Hydrochloride 21 % Braun.
Active substance: obeticholic acid
The marketing authorisation holders of medicinal products containing obeticholic acid inform about the revocation of the marketing authorisation because the clinical benefit has not been confirmed in patients with primary biliary cholangitis.
Active substance: amidotrizoic acid
The company Dr. Franz Köhler Chemie GmbH informs that during the ongoing stability program visible particles have been found in the medicinal products Peritrast 180/31%, Peritrast Infusio 31% (retro) and Peritrast 300/60%.
Active substance: glatiramer acetate
The marketing authorisation holders of glatiramer acetate-containing medicinal products provide information about anaphylactic reactions that can occur shortly after the administration of glatiramer acetate, even months to years after the start of treatment.
Active substance: voxelotor
Pfizer Europe would like to inform you that the marketing authorisation for Oxbryta is suspended in the European Union as a precautionary measure while the review of the benefits and risks is ongoing.
Active substance: medroxyprogesterone acetate
The marketing authorisation holder of medroxyprogesterone acetate-containing medicines would like to inform you about the increased risk of developing meningioma with high doses of medroxyprogesterone acetate.
Active substance: 5-Fluorouracil
The marketing authorisation holders of 5-fluorouracil containing medicines would like to inform that in patients with moderate or severe renal impairment, blood uracil levels used for dihydropyrimidine dehydrogenase (DPD) phenotyping should be interpreted with caution as there is an increased risk of misdiagnosis of DPD deficiency, which may lead to underdosing of 5-fluorouracil and thus reduced treatment efficacy.
