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Phil, Nancy and List, Thanks Phil that is helpful, And to Nancy this is the kind of thing that I think winds up confusing to lay people and can cause them not to take a particular drug. The experience with the condition rhabdomyolysis is rare and unproven. Any drug including ASA can have rare side effects including death in very small numbers. The risk of not taking the drug must be weighed against the risk of taking it. Also I think the risk of someone focussing on and worrying about a particular side effect must be weighed against its likelihood of occurrence. IMHO the risk of rhabdomyolysis is so low that the worry about it is more likely to do harm than is the chance of developing the condition itself. Rhabdomyolysis is listed because it has been reported and therefore a physician should take it into account if a patient exhibits symptoms. It should not be a factor in whether a patient chooses to take a drug or not. A statement by the physician that- "this is a new drug and sometimes unreported side effects can occur" and to "be cautious and report anything which you are concerned is serious whether it appears related to the medication or not"- should suffice. I belabor this point only because I have seen many patients check out a drug in the PDR or PI and come in and ask about a potential side effect and worry about it until they talked themselves into it (I practiced psychiatry for 20+ years prior to my retirement with PD). If your personality is to worry about potential side effects then one IMO should not read the information- but possibly have it available (e.g.. to check on-line) in case a rare symptom does occur . If you tend to not be a worrier or one who tends to ignore physical illness then by all means read as much as you can about the drugs that you are taking. Knowledge is Power but knowledge about what you don't know is a weakness. - for professionals as well as laymen. Thanks for letting me get this rant off my chest and clarify my thinking about the subject. As Dennis Miller says. "That's what I think, I may be wrong". Charlie ----- Original Message ----- From: Phil Tompkins <[log in to unmask]> To: <[log in to unmask]> Sent: Wednesday, December 15, 1999 1:24 PM Subject: Re: Rhabdomyolysis (very long) > 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."