FDA批准含叶酸的复方口服避孕药Beyaz片剂上市
9月24日，美国食品药品管理局（FDA）批准拜耳公司雌激素/孕激素的复方口服避孕药Beyaz片剂上市。该复方药物含有左旋叶酸钙0.451mg。目前临床医学已确认人神经管缺陷（例如脊柱裂）与叶酸水平低有关，通常建议孕期妇女补充叶酸。叶酸属于水溶性B族维生素，左旋叶酸钙是叶酸的代谢产物，有助于体内新细胞的形成和养护。
Beyaz是FDA基于含相同剂量雌激素和孕激素的药物YAZ获批的经验批准的，YAZ获批的适应证有：避孕；治疗因服用口服复方避孕药而引起的女性经前情绪障碍（PMDD）；治疗14岁以上女性中等程度的痤疮，但此用法仅适用于患者愿意选择口服复方避孕药避孕的情况。
除具有已获批药物YAZ的上述适应证外，Beyaz获批的另一个适应证是：用于升高选择口服复方避孕药避孕的女性体内的叶酸水平，降低妇女用药期间怀孕或停药后短时间内怀孕时罹患神经管损伤的风险。
在美国开展的一项针对Beyaz临床疗效的多中心、双盲、随机对照临床试验，共纳入379名18～40岁的健康女性受试者，均单独使用Beyaz或YAZ24周以上，试验发现Beyaz能够增加女性体内的叶酸水平。德国的一项关于Beyaz的研究发现，停药后数周内，用药者体内的叶酸水平仍较高。Beyaz用于避孕、PMDD和痤疮时的安全性和有效性数据则来源于已获批的YAZ的临床试验。
Beyaz临床试验中常见不良反应有：不规则子宫出血、恶心、乳房压痛、头痛。其他严重不良反应包括血管事件（血栓）和肝脏疾病。考虑到吸烟会增加严重心血管事件的发生风险，FDA建议35岁以上的吸烟女性不使用该药物。Beyaz的相关临床研究并未发现Beyaz与YAZ相比在安全性方面的差别。

What is Beyaz® prescribed for?
For women who choose the Pill for birth control, Beyaz is approved to:
Prevent pregnancy - 99% effective when taken as directed
Provide a daily dose of folate supplementation, which is recommended for women in their reproductive years. Folate lowers the risk of having rare neural tube defects in a pregnancy occurring during Beyaz use or shortly after stopping
Treat premenstrual dysphoric disorder (PMDD)
Beyaz is not approved to treat Premenstrual Syndrome (PMS), a less serious set of symptoms occurring before your period
Treat moderate acne in women at least 14 years of age
Who should not take Beyaz?
Do not use Beyaz if you smoke and are over age 35. Smoking increases your risk of serious side effects from the Pill, which can be life-threatening, including blood clots, stroke, or heart attack.
This risk increases with age and number of cigarettes smoked.
Do not use Beyaz if you have kidney, liver, or adrenal disease because this could cause serious heart and health problems, or if you have or have had blood clots, certain cancers, history of heart attack or stroke, or if you are or may be pregnant.
What are the most serious risks of taking Beyaz?
Beyaz increases the risk of serious conditions including blood clots, stroke, and heart attack.
These can be life-threatening or lead to permanent disability. The risk of blood clots is highest during the first year of use. This increased risk is highest when
you first start taking birth control pills and when you restart the same or different birth control pills after not using them for a month or more. Users of drospirenone-containing pills (like Beyaz) may have a higher risk of blood clots than users of birth control pills that do not contain drospirenone. Talk to your healthcare provider about your risk of blood clots before deciding which Pill is right for you.
In addition, drospirenone is a different kind of hormone that for some may increase potassium too much.
Consult your healthcare provider if you are on daily long-term treatment for a chronic condition with medications that may also increase potassium (see below), as you should have a blood test to check your potassium level during the first month of taking Beyaz .
Call your healthcare provider right away if you have:
Persistent leg pain; sudden shortness of breath; sudden blindness, partial or complete; severe pain in your chest; sudden, severe headache unlike your usual headaches; weakness or numbness in an arm or leg, or trouble speaking; yellowing of the skin or eyes
What medications may increase potassium?
NSAIDs–ibuprofen (Motrin, Advil), naproxen (Aleve® and others) when taken long-term and daily for arthritis or other problems, potassium-sparing diuretics (spironolactone and others), potassium supplementation, ACE inhibitors (Capoten, Vasotec, Zestril, and others), angiotensin-II receptor antagonists (Cozaar, Diovan,
Avapro, and others), aldosterone antagonists, and heparin.
What are the most common side effects in Beyaz clinical trials?
The most common side effects were headache/migraine, menstrual irregularities, nausea/vomiting, breast pain/tenderness, fatigue, irritability, decreased libido, weight gain, and mood changes.
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20127901105632.PDF

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注：以下产品不同规格和不同价格，购买以咨询为准！
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产地国家: 美国
原产地英文商品名:
YAZ (3/0.02)MG/TAB 84TABS
原产地英文药品名:
DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM
中文参考商品译名:
YAZ (3/0.02)毫克/片 84片
中文参考药品译名:
屈螺酮/乙炔雌二醇/甲基四氢叶酸钙
生产厂家中文参考译名:
拜耳
生产厂家英文名:
BAYER HLTHCARE
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产地国家: 德国
原产地英文商品名:
YAZ (3/0.02)MG/TAB 28TABS
原产地英文药品名:
DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM
中文参考商品译名:
YAZ (3/0.02)毫克/片 28片
中文参考药品译名:
屈螺酮/乙炔雌二醇/甲基四氢叶酸钙
生产厂家中文参考译名:
拜耳
生产厂家英文名:
BAYER HLTHCARE
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产地国家: 德国
原产地英文商品名:
YAZ (3/0.02)MG/TAB 84TABS
原产地英文药品名:
DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM
中文参考商品译名:
YAZ (3/0.02)毫克/片 84片
中文参考药品译名:
屈螺酮/乙炔雌二醇/甲基四氢叶酸钙
生产厂家中文参考译名:
拜耳
生产厂家英文名:
BAYER HLTHCARE
该药品相关信息网址1:
http://beyaz.com/
该药品相关信息网址2:
www.drugs.com/beyaz.html