Petition to the FDA to Ban Third Generation Oral Contraceptives Containing Desogestrel due to Increased Risk of Venous Thrombosis

نویسنده

  • Andrew Von Eschenbach
چکیده

Public Cit izen , represent i ng more than 100 ,000 con sumers nationwide , hereby pet itions the Food and Dr ug Adm i nistra tion (FDA) pursuant to the Federal Food , Drug and Cosmetic Act 2 1 U . S .C . Section 355(e)(3), and 21 C.F .R . 10 .30 , to immed iately ban the th ird generation oral contracept ives contain i~cn .dQmaParrPl d~~tothe approximately doubled risk of venous thrombosi s ( 30 cases for every 500 ,000 users per year o i r g r ion or con racep i pared to 15 ca ses for eve ry 1 00 , 000 use rs of second generation oral contracep tives) and lack of eviden ce of clinical benefit as compared to the second generation oral contrac eptives . The th ird g enerat io n oral contraceptives conta ining desogestrel are :

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منابع مشابه

Petition to the FDA to Ban Third Generation Oral Contraceptives Containing Desogestrel due to Increased Risk of Venous Thrombosis (HRG Publication

Public Citizen, representing more than 100,000 consumers nationwide, hereby petitlons the Food and Drug Administration (FDA) pursuant to the Federal Food, Drug and Cosmetic Act 21 U.S.C. Section 355(e)(3), and 2 1 C.F.R. 10.30, to immediately ban the third generation oral contraceptives containing desogestrel due to the approximately doubled risk of venous thrombosis (30 cases for every 100,000...

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[Third generation oral contraceptives and risk of venous thrombosis].

OBJECTIVE To evaluate quantitatively articles that compared effects of second and third generation oral contraceptives on risk of venous thrombosis. DESIGN Meta-analysis. STUDIES Cohort and case-control studies assessing risk of venous thromboembolism among women using oral contraceptives before October 1995. MAIN OUTCOME MEASURES Pooled adjusted odds ratios calculated by a general varian...

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Risk of Arterial Thrombosis in Relation to Oral Contraceptives (RATIO) study: oral contraceptives and the risk of ischemic stroke.

BACKGROUND AND PURPOSE Epidemiological studies have shown an increased risk of venous thrombosis in women taking third-generation oral contraceptives, ie, those containing the progestogens desogestrel or gestodene. This study assesses the risk of ischemic stroke with several types of oral contraceptives. METHODS A multicenter, population-based, case-control study was performed in 9 Dutch cent...

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Pulmonary embolism in a healthy woman using the oral contraceptives containing desogestrel

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Enhancement by factor V Leiden mutation of risk of deep-vein thrombosis associated with oral contraceptives containing a third-generation progestagen.

Recent concern about the safety of combined oral contraceptives (OCs) with third-generation progestagens prompted an examination of data from a population-based case-control study (Leiden Thrombophilia Study). We compared the risk of deep-vein thrombosis (DVT) during use of the newest OCs, containing a third-generation progestagen, with the risk of "older" products. We also investigated the inf...

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تاریخ انتشار 2007