Ärztliche Aufklärungspflichten nach Bekanntgabe eines Warnhinweises über unerwünschte Arzneimittelwirkungen

BACKGROUND: Based on a recent warning from the drug authorities about increased suicidality among users of hormonal contraceptives, this article discusses the legal consequences of translating novel findings from clinical trials into altered contents of gaining informed consent during the medical consultation. METHODS AND RESULTS: Comprehensive information in accordance with § 630e German Civil Code (BGB) requires that rare drug reactions be mentioned by the prescribing physician, when they are associated with serious sequelae. This act regulates the treating physician’s obligations to inform about complications for both preventive and curative treatment options. In this paper, we refer to the scientific evidence level of data from clinical trials as the key feature for implementing altered medical information in the proper conduct of acquiring the consent of the patient in line with § 630e BGB. The article discusses how additions and amendments to the package leaflet and the expert information will impact on the obligations for the treating party to provide information for the patient in order to obtain informed consent. In particular, we focus on the relationship between the obligations for the physician prescribing oral contraceptives on an individual case and the generalized information conditions according to § 11 and § 11a German Medicinal Products Act. DISCUSSION: Current warnings of the drug authorities in the form of red-hand letters do not necessarily have legal consequences for gaining informed consent during the medical consultation.