Germany. The Federal Institute of Drugs and Medical Devices has announced its intention to revoke the marketing authorizations for ionic contrast media containing lysine amidotriazoate, iotalamic acid or ioxitalamic acid, either alone or in combination, for intravasal administration, because their use has been associated with severe adverse reactions including hypotension, arrhythmias, pulmonary oedema and renal disorders.

At the same time, the Institute intends to restrict the indications for products that are currently indicated for intra-arterial and intravenous use and for use in the body cavities to the latter indication only.

Reference: Notification from the Federal Institute for Drugs and Medical Devices, 6 July 1998.