Invokana.(canagliflozin)

Invokana(Canagliflozin)是通常规定的糖尿病调解,以帮助2型糖尿病患者控制其血糖水平。它属于一类称为SGLT2抑制剂的药物,通过支持患者肾脏从血液中除去葡萄糖的能力。然而,2015年,美国食品和药物管理局(FDA)警告说,同一课程中的入侵和其他药物可能导致血液中称为酮类的酸累积,这可能导致称为酮症中的病症。这种药物也可能与肾衰竭和心脏病发作的风险增加相关联。

Invokana.

通过“CFZ”标记识别,Invokana可在100毫克和300mg片中获得。


临床数据

通用的:Canagliflozin
制造商:Johnson & Johnson
(marketed byJohnson & Johnson在美国)

FDA Approved:2013年3月29日
Legal Status:Prescription only
妊娠状况:C (risk not ruled out)
管理途径:Oral
Method:100 mg, 300mg (tablets)
Synonym:Invokana.
Uses:作为饮食和锻炼的辅助,以改善2型糖尿病患者血糖控制。
召回状态和安全信息:查看状态


Side Effects & Complaints

Side effects reported include low blood pressure, vomiting, diarrhea, or excessive sweating. Low blood sugar (hypoglycemia) may also occur. Symptoms of low blood sugar include headache, hunger, sweating, irritability, dizziness, nausea, an increased heart rate, and anxiety or shakiness.

More severe side effects have also been reported by patients using Invokana. These include a higher risk of bone fractures, lightheadedness, pain or burning upon urination, genital infections (with symptoms like pain, burning, itching, redness, swelling, odor, or discharge), pain or sores in the legs and feet, dehydration, kidney problems, and ketoacidosis.

Ketoacidosis and kidney problems have both become significant concerns surrounding this medication. It has lead to several hospitalizations and complaints filed with the FDA. Symptoms include nausea, vomiting, stomach pain, confusion, unusual or excessive drowsiness, and trouble breathing. Symptoms of kidney problems may include urinating less than usual or not at all, swelling in the feet or ankles, and feeling tired or short of breath.

Invokana不应被严重的肾脏疾病的患者使用,透析或怀孕或母乳喂养。其他条件的人,包括肾脏或肝病,膀胱问题的历史,低血压,电解质失衡,高胆固醇或糖尿病酮症病症应在使用之前咨询他们的医生。

Invokana.Adverse Event Reports: 2013-2015

The FDA received 20 reports of patients experiencing ketoacidosis while taking Invokana between March 2013 and June 2014. These adverse events are listed in the agency’s Adverse Events Reporting System (FAERS). All 20 of the patients named in the reports required either emergency room treatment, admission to the hospital, or both in order to treat their ketoacidosis.

虽然它可能发生在任何糖尿病患者中,但对FDA数据库中的不良事件报告的审查表明,患者患有这种药物的酮症病症并不典型的2型糖尿病患者。具体而言,它们的血糖仅略微升高。虽然重大疾病,减少食物和液体摄入量,而且胰岛素剂量减少可能与酮症中毒剧集研究有关尚未确认联系。

此外,9个临床试验的分析revealed a slightly higher risk of bone fractures. This risk appeared to increase after only a few months of taking the medication and occured despite relatively low impact to the bones. A separate study indicated that Invokana may also cause a loss of bone density in the hip and lower spine which can lead to a greater risk of hip and spine fractures. On September 10, 2015, the FDA released a drug safety communication addressing the risk of bone fractures and the loss of bone density in the hip and spine.

The FDA has also issued a safety alert warning that discusses an increased risk of leg and foot amputations required for Invokana patients. Most of the amputations documented to date involved the removal of one or more toes. However, at least one study failed to find an increased risk in the patients it studied leading the FDA to continue their evaluation.

More Invokana side effects information →


Lawsuits & Injuries

从2013年3月到2015年10月,FDA收到了101例确认案例报告,患有肾损伤的患者,同时使用Invokana(73名患者)或密切相关的药物Farxiga(Dapagliflozin)。几乎所有所需的住院治疗他们的伤害。二十二名患者在重症监护病房中需要治疗。四名患者死亡,两种来自心脏相关的条件。十五名患者需要透析,因为它们的肾脏无法处理从血液中除去废物的任务。虽然三分之二的患者脱掉药物恢复,但11据报道,肾脏损害是永久性的。

Several lawsuits have been filed concerning the medication’s involvement in cases of kidney disease, heart attacks, and ketoacidosis. The lawsuits claim that if the manufacturer – Johnson & Johnson – had properly warned the injured patients’ doctors about the increased risks associated with Invokana the doctors would either have prescribed a different medication or would have monitored the patients’ heart and kidney functions more closely.


类似的药物

  • Invokamet (canagliflozin and metformin)
  • 法西加(Dapagliflozin)
  • Xigduo XR (dapagliflozin and metformin extended-release)
  • Jardiance (empagliflozin)
  • Glyxambi (empagliflozin and linagliptin)
  • Synjardy (empagliflozin and metformin)

Invokana.Images

Invokana 100mg和300毫克标签图像
Invokana 100mg和300毫克标签图像

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