BfArM Drug Safety Communications

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.

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.

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.

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.