BfArM Drug Safety Communications

Mysimba Cardiovascular Risk and Annual Assessment Requirements

BfArM, in agreement with EMA, issued a Direct Healthcare Professional Communication regarding Mysimba (naltrexone/bupropion). The communication addresses long-term cardiovascular risks that have not been fully determined for patients treated beyond one year. New recommendations include discontinuation of treatment after one year if patients have not maintained at least 5% weight loss, and mandatory annual cardiovascular risk assessments for treatment continuation decisions.

Eberth Antibiotics - Outdated Package Inserts Create Patient Safety Risk

Dr. Friedrich Eberth Arzneimittel GmbH issued a Direct Healthcare Professional Communication (DHPC) via BfArM alerting that certain batches of nine antibiotic and antifungal products have outdated package inserts, creating a potential patient safety risk. Affected products include multiple strengths of cefazolin, cefotaxime, ceftazidime, ceftriaxone, levofloxacin, moxifloxacin, and voriconazole. Healthcare professionals are advised to discard outdated package inserts and refer to the current package inserts provided with the communication.

Accupaque Visipaque Batch Risk Alert: Particle Contamination in Iohexol Iodixanol Solutions

GE Healthcare Buchler GmbH & Co. KG issued a Direct Healthcare Professional Communication (DHPC) alerting to a potential risk of particles in certain batches of Accupaque (iohexol) and Visipaque (iodixanol) solutions for injection filled into polypropylene bottles. The company instructs that only clear, particle-free solutions may be used per the Summary of Product Characteristics (SmPC), and this must be verified prior to administration.

Phenhydan Injection: DHPC on Visual Particles, Filter Required

BfArM published an updated DHPC from Desitin Arzneimittel GmbH regarding Phenhydan solution for injection (phenytoin sodium), following particle contamination identified in batch 021950 during official sample analysis. The company clarified that a syringe filter with 0.2-0.45 µm pore size must be used when drawing up the solution, then removed before patient administration. This supersedes the November 2025 filter guidance which was corrected for accuracy.

Arixtra Recall: Needle Iron Particle Discoloration in Pre-filled Syringes

BfArM issued a Drug Safety Communication regarding Viatris Healthcare Limited's Arixtra (fondaparinux sodium) pre-filled syringes. Reports indicate brown discoloration and blockage in needles caused by oxidized iron particles. Affected batches must not be dispensed or administered if discoloration is observed.

Tegretal Suspension Use Restricted in Newborns

The German Federal Institute for Drugs and Medical Devices (BfArM) has issued a direct healthcare professional communication restricting the use of Tegretal Suspension (carbamazepine) in newborns due to high propylene glycol content. This restriction is to prevent serious side effects in infants.

Kisqali Tablets: Updated Storage Conditions and Shelf Life

Novartis Pharma GmbH has updated the storage conditions and shelf life for Kisqali 200 mg film-coated tablets. The medicine no longer requires refrigeration and now has an authorized shelf life of 2 years. This information letter was issued by the BfArM.

Arixtra Quality Defect: Needle Discoloration and Iron Particle

The German Federal Institute for Drugs and Medical Devices (BfArM) issued a notice regarding a quality defect in Arixtra pre-filled syringes. Reports indicate brown discoloration and needle blockage due to oxidized iron particles, posing a risk to patients. Healthcare professionals are instructed not to dispense or administer affected products.

Digimerck Tablets Quality Defect: Degradation Products May Exceed Limit

The German Federal Institute for Drugs and Medical Devices (BfArM) issued a Direct Healthcare Professional Communication regarding Digimerck 0.07 mg tablets. A quality defect has been identified where degradation products may slightly exceed the specification limit by the end of the product's shelf life. Distribution was discontinued in 2022.

Melphalan AqVida: Risk of Overdose Due to Higher Concentration

The German Federal Institute for Drugs and Medical Devices (BfArM) issued a communication regarding Melphalan AqVida RTD 90 mg/ml, a new formulation with an 18-fold higher concentration than existing melphalan products. This increased concentration poses a potential risk of overdose for patients.