Yaz-drospirenone（ドロスピレノン）の安全性を確認する
ヤーズ配合錠
成分：1錠中ドロスピレノン3mg及びエチニルエストラジオールベータデクスとしてエチニルエストラジオール0.020mg含有
この薬24錠とプラセボ4錠で１パックらしい。ヤーズフレックスも成分は同じ。おそらく錠数が変わるのだと思われる。
イーファーマによればドロスピレノン・エチニルエストラジオール ベータデクス錠 には次の3種類の薬がある。
①商品名 ヤーズフレックス配合錠
経路：内服薬 / 規格：1錠 / 一般名：ドロスピレノン・エチニルエストラジオール ベータデクス錠 / 薬価：280.10 / メーカー：バイエル薬品薬効：個々の器官系用医薬品 ホルモン剤（抗ホルモン剤を含む） 混合ホルモン剤 卵胞ホルモン，黄体ホルモン混合製剤
②商品名 ヤーズ配合錠
経路：内服薬 / 規格：1錠 / 一般名：ドロスピレノン・エチニルエストラジオール ベータデクス錠 / 薬価：243.10 / メーカー：バイエル薬品薬効：個々の器官系用医薬品 ホルモン剤（抗ホルモン剤を含む） 混合ホルモン剤 卵胞ホルモン，黄体ホルモン混合製剤
③商品名 ヤーズ配合錠（バイエル薬品）
経路：内服薬 / 規格：1シート / 一般名：ドロスピレノン・エチニルエストラジオール ベータデクス錠 / 薬価：6807.20 / メーカー：バイエル薬品
WHOの避妊薬に関する注意書き ヤーズはFDAから2008年頃から様々なタイプの避妊薬について安全性の確認を始め、2012年にはドロスピレノン含有のピルで血栓のリスクが高まる可能性を指摘した。
Combined hormonal oral contraception and risk of venous thromboembolism (VTE)
2009年のFDAがYazの過剰広告に対応した時のNew York Timesの記事２本
A Birth Control Pill That Promised Too Much
By Natasha Singer
Feb. 10, 2009
Bayer HealthCare Pharmaceuticals has just introduced a new $20 million advertising campaign for Yaz, the most popular birth control pill in the United States.
But the television ads, now running during prime-time shows like “Grey’s Anatomy” and on cable networks, are not typical spots promoting the benefits of a prescription drug. Instead, they warn that nobody should take Yaz hoping that it will also cure pimples or premenstrual syndrome.
As part of an unusual crackdown on deceptive consumer drug advertising, the Food and Drug Administration and the attorneys general of 27 states have required Bayer to run these new ads to correct previous Yaz marketing....
NYタイムズ2009年の記事
Health Concerns Over Popular Contraceptives
By Natasha Singer
Sept. 25, 2009The oral contraceptives Yaz and Yasmin are the top-selling pharmaceutical line for Bayer HealthCare, largely as a result of marketing that presents them as much more than mere pregnancy prevention.
Yaz, in particular, the top-selling birth control pill in the United States, owes much of its popularity to multimillion-dollar ad campaigns that have promoted the drug as a quality-of-life treatment to combat acne and severe premenstrual depression.
Yaz, a newer sister drug to Yasmin, contains less estrogen. The franchise had worldwide sales of about $1.8 billion last year, based on Bayer’s successful positioning of Yasmin and Yaz as the go-to drug brands for women under 35.
But recently, the Yaz line’s image has been clouded by concerns from some researchers, health advocates and plaintiffs’ lawyers. They say that the drugs put women at higher risk for blood clots, strokes and other health problems than some other birth control pills do....
2009年にFDAによるヤーズのリコール疑惑についてCBSが載せている2010年の記事。訴訟が次々と行われていることや死亡例などを報じる関連記事4本あり。
Did You Know the FDA Recalled Bayer's Yaz Contraceptive? Neither Did Anyone Else
BY JIM EDWARDSUPDATED ON: MAY 6, 2010 / 4:22 PM / MONEYWATCH
アメリカ医療法医学専門家協会の2012年対バイエル集団訴訟に関する記事
Bayer Settles Yaz Lawsuits | AMFS
By AMFS June 25, 2019In November 2012, ABC News reported Bayer, the manufacturer of Yaz, a birth control pill, settled Yaz lawsuit claims at a fast pace. Bayer appears to be taking the approach to compensate those injured and put the situation to rest.
RD Legal Funding issued a press release on the Yaz or Yasmin birth control pill allegedly having caused people to suffer blood clots. ABC News reported the pill also caused individuals DVT, stroke or Pulmonary Embolism.
The Yaz Resource Center cautions victims to seek a lawyer with experience in defective drug litigation, and recommends people engage lawyers and law firms who have already settled Yaz lawsuits. According to the Yaz Lawsuit Center, Yaz lawsuits are handled on an individual basis, rather than as a single Yaz class action lawsuit. A class action lawsuit bundles together cases against a common defendant and if successful, a court grants a settlement that is equally split among individual class members according to predetermined calculations....
薬害について情報提供するDrug Dangerの2013時点でのYaz情報
FDAの認可などについて時系列的に説明されている。
Yaz Birth Control - Yaz Side Effects, FDA Warning & Lawsuits
2011年までのYazに関する詳細と経過を紹介している記事
injurylawyer-news.com
History of Yaz and Yasmin in the United States:
2001 – The FDA approves Yasmin, the first “fourth generation” birth control pill, which contains the hormone dropsirenone. Dropsirenone is allegedly responsible for Yaz side effects including dangerous blood clots and gallbladder problems.
March 2006 – The FDA approves Yaz for the prevention of pregnancy.
October 2006 – The FDA approves Yaz for the treatment of PMDD, a severe form of PMS. Yaz is not approved to treat ordinary PMS.
January 2007 – Yaz is approved to treat moderate acne.
October 2008 – The FDA sends a warning letter to Bayer about its marketing campaign, which caused consumers to believe that Yaz was effective for the treatment of PMS and for all stages of acne and which understated and obscured the risks of blood clots and other serious Yaz side effects.
February 2009 – Bayer HealthCare spends $20 million on advertisements to comply with FDA orders to inform the public about the actual indications and risks of Yaz.
April 2010 – The FDA updates the Yaz warning label with additional information about the possible risks of serious blood clots and vascular problems.
March 2011 – The FDA updates the labels on Yaz and other oral contraceptives containing dropsirenone to reflect new information about the risks of blood clots.
December 2011 – An FDA advisory panel decides in a 21-5 vote that the product warnings on Yaz are still inadequate and do not inform consumers about potentially fatal side effects that may lead to deep vein thrombosis, stroke or pulmonary embolism.
バイエルの集団訴訟が解決したと報じている法律事務所のページ
2012年の記述？
2013年にバイエルが賠償金を払い解決したとしている記事
www.lexisnexis.com
この頃から（もっと前から）情報が秘されたのではないだろうか。
drugwatchによるYazに関する総合的情報のページと、Yaz訴訟のページ
2019年1月現在、1万9000件を超えたMDL（multi-district litigation）はすべて解決されと書いている。
Yaz Birth Control: Uses, Dosages, Interactions and WarningsYaz Lawsuits | Blood Clot, Heart Attack & Stroke Claims
Over 19,000 Yaz claims were resolved through multidistrict litigation in United States District Court for the Southern District of Illinois.
とりあえず以上。
