Petition to the FDA to Ban Third Generation Oral Contraceptives Containing Desogestrel due to Increased Risk of Venous Thrombosis (HRG Publication
نویسنده
چکیده
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 users per year of third generation oral contraceptives compared to 15 cases for every 100,000 users of second generation oral contraceptives) and lack of evidence of clinical benefit as compared to the second generation oral contraceptives. The third generation oral contraceptives containing desogestrel are:
منابع مشابه
Petition to the FDA to Ban Third Generation Oral Contraceptives Containing Desogestrel due to Increased Risk of Venous Thrombosis
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 ( ...
متن کامل[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...
متن کاملRisk 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...
متن کاملPulmonary embolism in a healthy woman using the oral contraceptives containing desogestrel
Venous thromboembolism is well known as one of the rare but serious adverse effects of combined oral contraceptives (COCs). The COCs with third and fourth generation progestogens were found to have higher risk of venous thrombosis than those with second generation progestogens. We present a case of pulmonary embolism in a 23-year-old nulligravid woman who was using COCs containing the third gen...
متن کاملEnhancement 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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