When we receive a report of a potential adverse drug reaction, the report will be entered in the Lundbeck Safety Database and it will be evaluated by a team of medical doctors, nurses and pharmacists. In case of any ambiguity or missing information in the report, we are obliged to contact the reporter for additional information. If the report is received from a patient, we will ask for permission to contact the patient’s doctor to confirm the provided information and potentially also request additional relevant information in order for us to assess the case.
Adverse drug reaction reports will be reported as individual cases to worldwide Health Authorities, such as the U.S. Food and Drug Administration (FDA) and also included in cumulative reports according to national legislation and requirements. In addition, they will be included in the ongoing monitoring for new signals that will help us to identify potential new risks associated with our products. Patient information and other personal data reported to Lundbeck will be further processed in an anonymized manner according to current Data Protection laws.
If you experience a potential adverse drug reaction, please consult your doctor for advice.