In view of the available data found in the literature and spontaneous reports, including those describing the chronology of drug interactions between Amiodarone and Sirolimus, leading to increased toxicity of Sirolimus, PRAC considers the estimated cumulative data to be sufficient to support a causal relationship. The PRAC concluded that the information on products containing Amiodarone should be amended to reflect this drug interaction with Sirolimus appropriately.
Considering available data from the literature and spontaneous reports, PRAC believes that a causal relationship between amiodarone and the following adverse reactions: hallucinations, neutropenia, agranulocytosis, and decreased libido, is at least a reasonable possibility. PRAC concluded that information about products containing Amiodarone (IMU, SMPCs, PILs) should be changed accordingly.
