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INDOCIN & MECLOMEN "NOT FOR INITIAL USE" STATEMENTS SHOULD BE REMOVED FROM LABELING

Executive Summary

"Not for initial use" statements should be removed from the indications section of Indocin and Meclomen labeling, FDA's Arthritis Advisory Cmte. unanimously recommended at its April 30 meeting. With respect to Indocin (indomethacin), Cmte. Chairman Michael Weisman, MD, University of California/San Diego, commented that the principal reason for recommending removal of the label restriction is that Indocin "seems to have withstood the test of time of 20 years and is still available and is still widely prescribed." He added that the individual experience of cmte. members who treat rheumatic disease seems "to indicate that this [restriction] could be deleted." Indocin's labeling currently states: "Because of its potential to cause adverse reactions, particularly at high dose levels, the use of Indocin in rheumatoid arthritis and osteoarthritis in adults should be carefully considered for active disease unresponsive to adequate trial with salicylates and other measures of established value, such as appropriate rest." The "Indications" section of Meclomen (meclofenamate) labeling states that "Meclomen is not recommended as the initial drug for treatment because of gastrointestinal side effects, including diarrhea which is sometimes severe." FDAer John Harter, MD, stated that although there is an increased incidence of diarrhea with Meclomen, there is no "doubt that it looks like it's manageable." He said that diarrhea is "probably not" something that would indicate a "non-recommendation" for use in the label. The cmte. also recommended moving a statement on diarrhea from the "Warning" section to the "Precautions" section of the labeling. Harter commented that the "Warnings" section should be reserved for "more serious" problems and a move to the "Precautions" section would be "consistent with the fact that diarrhea is not such an important thing." The cmte. was also asked to consider whether a "not for initial use" statement is appropriate for the labeling of any drugs. Weisman commented that "is appears that the 'not for initial use' concept has been used as a proxy, or almost a euphemism, for other issues" related to the drug. Examples of such issues that it has disease modifying potential, has a propensity to produce certain special side effects, may leave certain populations at higher risk, or may only be as effective as aspirin. Weisman said such drug characteristics should "somehow find their way into the package insert and replace this kind of proxy statement about 'not for initial use.'" Commenting on the replacement of "not for initial use" with more specific statements about the particular properties of a drug, Harter suggested that both types of statements might be appropriate for a new compound. He said that "only under certain circumstances" would you start a patient out with a drug that has increased risk. Harter added that "the 'not for initial use' concept makes good medical sense. If you've got things you're familiar with that work in a patient, [then] why use a drug you don't know and there's not a lot known about." Harter also noted that "there's been some discussion over the years . . . that when we don't really know about a drug, the appropriate thing to do if you have some concerns, or even when any of them are first approved, is to make them 'not for initial use.'"

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