In rare cases, patients with asthma on Accolate may present with systemic eosinophilia, eosinophilic pneumonia, or clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition which is often treated with systemic steroid therapy. Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. These events have usually, but not always, been associated with reductions and/or withdrawal of steroid therapy. The possibility that Accolate may be associated with emergence of Churg-Strauss syndrome can neither be excluded nor established (see PRECAUTIONS, Eosinophilic Conditions).
Postmarketing Adverse Reactions: In addition to adverse events reported from clinical trials, the following events have been identified during world-wide post-approval use of ALBENZA. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to ALBENZA. Blood and Lymphatic System Disorders: Aplastic anemia, bone marrow suppression, neutropenia.
Blizzard and Kyle (1963) offered the first substantial evidence for the autoimmune concept. They found antiadrenal antibodies in 36 of 71 patients with Addison disease and antithyroid antibodies in 22. Hung et al. (1963) found circulating adrenal antibodies in 2 sibs with Addison disease. A third sib had died from Addison disease. One of the affected sibs also had hypoparathyroidism, pernicious anemia, and superficial moniliasis. The authors suggested the disorder may not be inherited as a simple mendelian recessive but may be autoimmune in nature.