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AYERST AYGESTIN "PROGESTIN THERAPY MADE SIMPLE" AD's

Executive Summary

AYERST AYGESTIN "PROGESTIN THERAPY MADE SIMPLE" AD's failure to include the drug's approved indications renders the piece "misleading" under FDA regs and the FD&C Act, the Health Research Group (HRG) asserted in a May 17 letter to Acting Com. Novitch. "By failing to list any of the approved indications for Aygestin in the ad and accompanying prescribing information, Ayerst is encouraging physicians to prescribe this drug, for an unapproved use," mainly as an estrogen supplement for prevention of post-menopausal bleeding, HRG Director Sidney Wolfe, MD, and researcher Cary LaCheen, declared. HRG noted that Aygestin (norethindrone acetate) is approved for treatment of amenorrhea, endomestriosis, and abnormal uterine bleeding due to "hormonal imbalance occurring in the absence of organic pathology." The consumer group asked FDA to halt the ads and "seriously consider invoking civil or criminal penalties against the mfr." HRG noted the ad is the second progestin ad this year the group has protested. Upjohn withdrew a Provera ad in early 1984 which claimed the drug reduced the likelihood of hyperplasia ("The Pink Sheet" Feb. 13, T&G-11). The Aygestin ad, which ran in May in OBGYN News, is designed to highlight the product's new unit-of-use packaging. The ad copy states that "each Cycle-Pack contains 10 5-mg tablets to help patients comply with their progestin regimen and increase the likelihood of therapeutic success." Although "the text of the advertisement refers to 'progestin therapy' and 'therapeutic success,' the indications for this therapy and the nature of this therapeutic success are never specified," Wolfe and LaCheen pointed out. "Nor does the accompanying prescribing information list any of the approved indications for this drug." Asserting that progestins are widely prescribed, though not approved, as supplements to post-monopausal estrogen therapy, HRG declared: "This ad may mislead some physicians, particularly new physicians just beginning to practice medicine to believe that Aygestin is approved as a routine estrogen supplement, particularly since progestins are typically used about 10 days each month (the number of days in the Cycle Pack) when they are added to estrogen replacement therapy."

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