Sarcoidosis is a granulomatous multiorgan diseases with an unknown etiology, with the predominant lung involvement.
Immunosuppressive agents such as
corticosteroids,
methotrexate, azathioprinum, ciclosporinum A,
chlorambucil,
cyclophosphamide, hydroxychlorochinum,
indomethacin, pentoxyfillinum,
thalidomide, leflunomidum, and
adalimumab, or
infliximab have been used in its treatment. It should be emphasized that the Summary of Products Characteristics (SPC) of these drugs does not specifically recommend their use in the
therapy for
sarcoidosis. That makes the application of the drugs in
sarcoidosis an
off-label use, which is not formally accepted by the authorities but is supported by medical bibliography or recommendations given by scientific bodies. Thus the off-label drugs raise legal, but also ethical and medical problems. The dosing regimen and the required
duration of therapy for
sarcoidosis are missing. In effect the
therapy usually follows the recommendations from the American and European Respiratory Societies (ATS/ERS), based on the long-term medical research. The American Food and Drug Administration recognizes the existence of the
off-label use. European legislations do not precisely specify the rules for the admissibility of the
off-label use. The doctrine of law assumes that the
off-label use constitutes a medical experiment. Therefore, the commencement of
therapy with such drugs requires patients' informed consent, which must be kept along with other medical records. Insufficient knowledge of the legal regulations may result in civil and professional liability of a physician supervising the
therapy of a
sarcoidosis patient, especially in case of adverse effects.