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: temozolomide
The companies concerned point out that cases of liver injury, including liver failure with lethal outcome, have been reported in patients treated with medicinal products containing temozolomide. The liver toxicity may not appear until several weeks or more after the beginning of therapy or after stopping the treatment with temozolomide. Therefore, liver function tests should be carried out at specified times.
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: risperidone, paliperidone
Important information on the risk of an intraoperative floppy iris syndrome (IFIS) in connection with administration of risperidone or paliperidone to patients undergoing cataract surgery.
Active substance: pioglitazone
The pharmaceutical entrepreneur is sending out a Dear Doctor Letter on Actos®, Competact® and Tandemact® giving information on new contraindications and warnings due to a slightly increased risk of bladder cancer.
Active substance: mycophenolate
As mycophenolate mofetil (MMF) and mycophenolic acid (MPA) are known to be genotoxic, it is recommended that the male patient or his female partner use reliable contraception during treatment and for at least 90 days after the end of the treatment.
Active substance: fusafungine
By way of a Dear Doctor Letter, the company concerned is informing healthcare professionals of the revocation of the marketing authorisations of medicinal products containing fusafungine (Locabiosol® as mouth and nose spray) within the EU.
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: dihydroergotoxine
The company Sigma-Tau Arzneimittel GmbH is circulating information that there are several indications for which medicinal products with the active substance dihydroergotoxine must no longer be prescribed in the future.
