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Charles T. Meyer, M.D. wrote: > Hans, > Thanks for the article on Rhabdomyolysis. Does anybody have the exact > wording of the package insert of Comtan regarding this condition. See below. Phil T. From Entacapone (Comtan) prescribing info from Novartis: http://www.pharma.us.novartis.com/product/pi/pdf/comtan.pdf > "Other Events Reported With Dopaminergic Therapy "The events listed below are rare events known to be associated with the use of drugs that increase dopaminergic activity, although they are most often associated with the use of direct dopamine agonists. "Rhabdomyolysis: Cases of severe rhabdomyolysis have been reported with Comtan use. The complicated nature of these cases makes it impossible to determine what role, if any, Comtan played in their pathogenesis. Severe prolonged motor activity including dyskinesia may account for rhabdomyolysis. One case, however, included fever and alteration of consciousness. It is therefore possible that the rhabdomyolysis may be a result of the syndrome described in Hyperpyrexia and Confusion (see PRECAUTIONS, Other Events Reported With Dopaminergic Therapy). "Hyperpyrexia and Confusion: Cases of a symptom complex resembling the neuroleptic malignant syndrome characterized by elevated temperature, muscular rigidity, altered consciousness, and elevated CPK have been reported in association with the rapid dose reduction or withdrawal of other dopaminergic drugs. Several cases with similar signs and symptoms have been reported in association with Comtan therapy, although no information about dose manipulation is available. The complicated nature of these cases makes it difficult to determine what role, if any, Comtan may have played in their pathogenesis. No cases have been reported following the abrupt withdrawal or dose reduction of entacapone treatment during clinical studies. Prescribers should exercise caution when discontinuing entacapone treatment. When considered necessary, withdrawal should proceed slowly. If a decision is made to discontinue treatment with Comtan, recommendations include monitoring the patient closely and adjusting other dopaminergic treatments as needed. This syndrome should be considered in the differential diagnosis for any patient who develops a high fever or severe rigidity. Tapering Comtan has not been systematically evaluated."