Important Safety Information about FORTEODuring the drug testing process, the medicine in FORTEO caused some rats to developabonecancercalledosteosarcoma. In people, osteosarcoma is a serious but rare cancer.
Osteosarcoma has been reported rarely in people who took FORTEO. It is not known if people who take FORTEO have a higher chance of getting osteosarcoma.
You should not take FORTEO for more than 2 years over your lifetime.
There is a voluntary patient registry for people who take FORTEO.
The purpose of the registry is to collect information about the possible risk of osteosarcoma in people who take FORTEO. For information about how to sign up for this patient registry, call 1-866-382-6813 or go to Do not use FORTEO if you are allergic to any of the ingredients in FORTEO.
Before you take FORTEO, you should tell your healthcare provider if you have Paget's disease of bone or other bone disease, have cancer in your bones, have trouble injecting yourself and do not have someone who can help you, are a child or young adult whose bones are still growing, have or have had kidney stones, have had radiation therapy, have or have had too much calcium in your blood, take medications that contain digoxin (Digoxin, Lanoxicaps, Lanoxin), or have any other medical conditions.
You should also tell your healthcare provider, before you take FORTEO, if you are pregnant or thinking about becoming pregnant. It is not known if FORTEO will harm your unborn baby. If you are breastfeeding or plan to breastfeed, it is not known if FORTEO passes into your breast milk. You and your healthcare provider should decide if you will take FORTEO or breastfeed. You should not do both.
FORTEO can cause serious side effects including a decrease in blood pressure when you change positions. Some people feel dizzy, get a fast heartbeat, or feel faint right after the first few doses.

This usually happens within 4 hours of taking FORTEO and goes away within a few hours.
For the first few doses, take your injections of FORTEO in a place where you can sit or lie down right away if you get these symptoms. If your symptoms get worse or do not go away, stop taking FORTEO and call your healthcare provider. FORTEO may also cause increased calcium in your blood.

Tell your healthcare provider if you have nausea, vomiting, constipation, low energy, or muscle weakness. These may be signs there is too much calcium in your blood.
Common side effects of FORTEO include nausea, joint aches, pain, leg cramps, and injection site reactions such as redness, swelling, pain, itching, a few drops of blood, and bruising.

These are not all the possible side effects of FORTEO.
The FORTEO delivery device has enough medicine for 28 days. It is set to give a 20-microgram dose of medicine each day. Before you try to inject FORTEO yourself, a healthcare provider should teach you how to use the FORTEO delivery device to give your injection the right way. Inject FORTEO one time each day in your thigh or abdomen (lower stomach area). Do not inject all the medicine in the FORTEO delivery device at any one time. Do not transfer the medicine from the FORTEO delivery device to a syringe.
This can result in taking the wrong dose of FORTEO. If you take more FORTEO than prescribed, call your healthcare provider. If you take too much FORTEO, you may have nausea, vomiting, weakness, or dizziness.
Keep your FORTEO delivery device in the refrigerator between 36° to 46°F (2° to 8°C). Do not freeze the FORTEO delivery device.

Do not use FORTEO if it has been frozen. Do not use FORTEO after the expiration date printed on the delivery device and packaging. Throw away the FORTEO delivery device after 28 days even if it has medicine in it (see the User Manual).

      
Forteo（副甲状腺激素）获准上市

            
据报道，礼来的副甲状腺激素Forteo(teriparatide  rDNA注射剂)得到了FDA的批准上市，在美国用于治疗绝经期妇女骨质疏松症，包括原发性或性腺功能减退性骨质疏松症的男性病人。
在美国，受骨质疏松症折磨的人高达一千万，每年并导致一百五十万例的骨折，单是治疗骨折的费用就达一百亿美元之多；然而目前治疗骨质疏松症的药物，仅能延缓骨质流失的速度而已。

最近研究成功的新药 Forteo，却能够加倍增加新骨形成的速度。制药公司希望Forteo能够获得美国食品暨药物管理局核准，于今年底成为处方药。

新药Forteo的临床试验结果令人十分鼓舞，因为它能减少百分之六十五的脊椎骨折，优于现有的药物，其它的药物如Fosamax，减少脊椎骨折的发生率为百分之四十八，Actonel 为百分之四一。

最近的一项研究中，一千六百三十七名绝经后至少曾发生过一次骨折的妇女参加了随机对比试验，在使用 Forteo 十八个月后，她们的骨质密度增加了百分之十三；另在动物实验时出现骨瘤的现象，在临床试验中并未发生。
Forteo的原始名称为teriparatide，由三十四个氨基酸组成，其功能类似于甲状旁腺激素。Forteo的主要缺点是必须每天注射一次，因此可能须像糖尿病患者注射胰岛素一样，骨质疏松症患者也要学会给自己打针。

欧洲药物评估机构（EMEA）表示支持礼来公司的骨质疏松药物Forteo（teriparatide，特立帕肽），但只限于在女性患者中使用。上个月美国FDA批准了这一药物用于治疗骨质疏松，包括男性病人和绝经后妇女。

EMEA称其科学委员会推荐批准这一药物用于绝经后妇女的骨质疏松。

但是没有提到男性患者。欧洲药物评估机构一般会在宣布支持后的几周内正式批准新药上市。Forteo是一种每天一次的针剂，与大多数骨质疏松药物防止和减少骨质损失不同的是，这种药物还能促进新骨形成。礼来公司在上个月公布的一项对照试验结果中说，Forteo治疗组的脊柱骨密度比默克公司的竞争产品Fosamax（alendronate，阿仑膦酸钠）高5倍。

唑来膦酸联合特立帕肽较单用更有效

ASBMR第31届年会2009年9月14日报道：一项新的研究表明，唑来膦酸与甲状旁腺素特立帕肽（Forteo）结合使用不影响特立帕肽的作用，而且可以增加作用效果。

这项部分双盲研究涉及4个国家的35个临床中心，共包括412例首次治疗的绝经后骨质疏松症女性，入组者的年龄在45至87岁。入组女性随机分配到3组：接受5mg静脉注射唑来膦酸联合每日皮下特立帕肽20mg治疗、只使用特立帕肽20mg治疗、或只使用唑来膦酸5mg治疗。
研究人员在基线处、13周、26周、52周时测量了入组者的腰椎和全髋骨密度，分析结果表明，腰椎骨密度在联合用药组、单用特立帕肽组,单用唑来膦酸组分别增加7.51%、7.05%、4.37%。
联合用药组与单用特立帕肽组的差异并不显著，而联合用药组较单用唑来膦酸组治疗更有效（P <.001）。与单用特立帕肽相比，联合用药显著增加13周和26周时的腰椎骨密度，并且显著增加13周、26周和52周时的全髋骨密度（P <.005），在整个实验过程中，骨转换标志物I型胶原的C-尾肽和N-末端前肽一直低与单用特立帕肽组。
联合用药组、单用特立帕肽组、单用唑来膦酸组严重副反应的总体发生率分别为9.5%、14.6% 和10.9%。