默克公司４月８日宣布，美国ＦＤＡ已经批准了该公司新药ＦＯＳＡＭＡＸ ＰＬＵＳ Ｄ的上市申请。ＦＯＳＡＭＡＸ ＰＬＵＳ Ｄ为骨质疏松治疗药物，含有７０ｍｇ福善美（ＦＯＳＡＭＡＸ，阿仑膦酸钠）和２８００ ＩＵ维生素Ｄ３，每周只需服用一次。福善美主要于绝经后患有骨质疏松症的妇女，能够降低髋部和脊柱骨折的发生率，是目前唯一一个和一周用量的维生素Ｄ３配伍的双磷酸化合物类药物。

How Do I Know FOSAMAX or FOSAMAX PLUS D is Working?

You will not feel it working, but you and your doctor can monitor your progress with a bone mineral density test prescribed by your doctor. Ninety-six percent of patients, on either a once-daily or once-weekly schedule, increased or maintained bone mass.

How Long Do I Take FOSAMAX or FOSAMAX PLUS D?
Only your doctor can determine how long you should keep taking FOSAMAX or FOSAMAX PLUS D. The effects will continue as long as you continue treatment. For most patients, that means your bone density will be maintained or increased and your bones will be less likely to fracture.

If you experience side effects, call your doctor right away.

Selected Cautionary Information About FOSAMAX and FOSAMAX PLUS D
You should not use FOSAMAX or FOSAMAX PLUS D if you have certain disorders of the esophagus (the tube connecting the mouth with the stomach), are not able to stand or sit upright for 30 minutes, have severe kidney disease, low blood calcium, or are allergic to FOSAMAX or FOSAMAX PLUS D. Before use, talk to your doctor if you have or have had stomach or digestive problems or problems with swallowing. You should tell your doctor about all medicines you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements. In addition, for FOSAMAX PLUS D, you should talk to your doctor if you have conditions that may cause an overproduction of vitamin D (eg, sarcoidosis, leukemia, lymphoma).

Stop taking FOSAMAX or FOSAMAX PLUS D and call your doctor right away if you develop new or worsening heartburn, difficult or painful swallowing, or chest pain because these may be signs of serious upper digestive problems, which can include irritation, inflammation, or ulceration of the esophagus. (See the Patient Product Information for more details.) If you develop severe bone, joint, and/or muscle pain at any time, contact your doctor. FOSAMAX AND FOSAMAX PLUS D may cause jawbone problems in some people. Jawbone problems may include infection, and delayed healing after teeth are pulled. Digestive side effects in studies were generally mild and included stomach pain, indigestion/heartburn, or nausea.

How to Take FOSAMAX 35-mg or 70-mg Once-Weekly Tablets, FOSAMAX 70-mg Once-Weekly Oral Solution, and FOSAMAX PLUS D 70-mg/2,800 IU Once-Weekly Tablets
Choose a day of the week that best fits your schedule. Take 1 FOSAMAX or FOSAMAX PLUS D dose on your chosen day, every week.

Tablets: Swallow 1 FOSAMAX or FOSAMAX PLUS D tablet with 6 to 8 ounces of plain water first thing in the morning before you have anything to eat or drink.

OR

Oral Solution: Drink 1 entire bottle of solution followed by at least 2 ounces (a quarter of a cup) of plain water.

Begin the day’s activities, but don’t lie down, eat, drink, or take other medications for at least 30 minutes. If you want to lie down after 30 minutes, you must eat breakfast first.

If you miss a dose, take only 1 dose of FOSAMAX or FOSAMAX PLUS D on the morning after you remember. Do not take 2 doses on the same day.

Continue your usual schedule of 1 dose once a week on your chosen day.

How to Take FOSAMAX 5-mg or 10-mg Tablets Once-Daily
Take FOSAMAX with 6 to 8 oz of plain water first thing in the morning before you have anything to eat or drink. Begin the day’s activities, but don’t lie down, eat, drink, or take other medications for at least 30 minutes. If you want to lie down after 30 minutes, you must eat breakfast first.

How to Take FOSAMAX 5-mg or 10-mg Tablets Once-Daily
Take FOSAMAX with 6 to 8 oz of plain water first thing in the morning before you have anything to eat or drink. Begin the day’s activities, but don’t lie down, eat, drink, or take other medications for at least 30 minutes. If you want to lie down after 30 minutes, you must eat breakfast first.

Selected Cautionary Information About FOSAMAX and FOSAMAX PLUS D
You should not use FOSAMAX or FOSAMAX PLUS D if you have certain disorders of the esophagus (the tube connecting the mouth with the stomach), are not able to stand or sit upright for 30 minutes, have severe kidney disease, low blood calcium, or are allergic to FOSAMAX. Before use, talk to your doctor if you have stomach or digestive problems. You should tell your doctor about all medicines you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.

In addition, for FOSAMAX PLUS D, you should talk to your doctor if you have conditions that may cause an overproduction of vitamin D (eg, sarcoidosis, leukemia, and lymphoma).

[-原产地英文商品名-]FOSAMAX PLUS D(ALENDRONATE SODIUM/CHOLECALCIFEROL))70 MG/2800IU X 4Tabs
[-原产地英文药品名-]ALENDRONATE SODIUM/CHOLECALCIFEROL))70 MG/2800IU
[-中文参考商品-]阿仑膦酸钠/维生素D3 70毫克/2800单位 4片/盒
[-中文参考药品-]阿仑膦酸钠/维生素D3 70毫克/2800单位
[-临床试验期-] 完成
[-中文适应病症参考-]骨质疏松
[-生产厂家中文参考-]默克制药
[-生产厂家英文名-]MERCK

默克公司每周一次的Fosamax在英国上市

默克公司的每星期一次配方的二磷酸盐Fosamax（alen-dronate）已在它的第一个市场欧盟被批准上市，它用于治疗和预防绝经后的骨质疏松症。

    该公司将通过共同承认程序寻求在欧盟的进一步的批准，而英国将作为参照成员国。

    新的70mg的每星期一次的Fosamax配方为23.12英磅供四个星期使用。它将与每日配方的费用相同。该公司说：每星期一次的70mg剂量与每日一次的10mg治方剂同样有效，但是可增加患者的顺从性。

    每星期一次的产品已在美国采用，在美国大约35％的新的每星期的Fosamax处方药是用于新配方的药品，在最近举行的会议期间，默克公司报告，在2000年第四个季度美国Fosamax的销售额增长了11％，达2.10亿美元，而该产品2000年在美国的总销售额增长了27％，达8.80亿美元。

    Fosamax是由于绝经后骨质疏松预防骨折的每星期一次的治疗剂，而其它的二磷酸盐也和每星期一次型的同样有效，因为它们以同样的方式结合到骨骼。Aventis/P&G公司的口服二磷酸盐，每星期配方的Actonel（risedronate）正处于用于绝经后骨质疏松的早期研究之中。

    罗氏公司也正在用它的二磷酸盐Bondronat（ibadronicacid）进行第Ⅲ阶段的试验，它是一种用于绝经后骨质疏松的每三个月一次的注射剂。