Seroquel XR(quetiapine fumarate)获得欧盟批准作为重度抑郁症辅助用药
继美国食品及药物管理局 （FDA）在2009年底批准阿斯利康抗抑郁剂 SEROQUEL XR（富马酸喹硫平）用于成年人重度抑郁症 （MDD） 的辅助治疗后。
近日;抗精神病药Seroquel XR再获欧盟委员会批准，作为辅助药物治疗重度抑郁症（MDD）。 SEROQUEL XR在获得欧盟批准之后，要在17个成员国通过后批准还需30天。
Seroquel XR已是在全球多个国家和地区获准治疗精神分裂症、双相躁狂症、双相情感障碍、广泛性焦虑症和重度抑郁症。Seroquel XR这次在欧洲获准作为治疗重度抑郁症的辅助药物是深受欢迎。
Seroquel XR在欧盟上市过程
2009年5月份，Seroquel XR作为治疗重度抑郁症的辅助用药的适应症在作为欧洲药物审批参照国的荷兰获准之后，阿斯利康随即向欧洲人用医疗产品委员会（CHMP）提出按照集中审批程序允许相同申请在其他欧盟国家获准，但遭到了拒绝，理由是认为Seroquel XR药物的风险-疗效比存在问题。
今年4月份，Seroquel X治疗重度抑郁症的申请在获得了CHMP的支持，认为药物用于那些对其他抗抑郁剂应答不充分的患者之后，所获得的疗效超过了潜在的用药风险。
Seroquel XR
Generic Name: quetiapine fumarate
Dosage Form: tablet, extended release
Important Safety Information About SEROQUEL XR
Elderly patients with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) treated with this type of medicine are at an increased risk of death, compared to placebo (sugar pill). SEROQUEL XR is not approved for treating these patients.
Antidepressants have increased the risk of suicidal thoughts and actions in some children, teenagers, and young adults. Patients of all ages starting treatment should be watched closely for worsening of depression, suicidal thoughts or actions, unusual changes in behavior, agitation, and irritability. Patients, families, and caregivers should pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. These symptoms should be reported immediately to the doctor. SEROQUEL XR is not approved for children under the age of 10 years.
Do not take SEROQUEL XR if you are allergic to quetiapine fumarate or any of the ingredients in SEROQUEL XR.
Stroke that can lead to death can happen in elderly people with dementia who take medicines like SEROQUEL XR.
Stop SEROQUEL XR and call your doctor right away if you have some or all of the following symptoms: high fever; excessive sweating; stiff muscles; confusion; changes in pulse, heart rate, and blood pressure. These may be symptoms of a rare, but very serious and potentially fatal, side effect called neuroleptic malignant syndrome (NMS).
High blood sugar and diabetes have been reported with SEROQUEL XR and medicines like it. If you have diabetes or risk factors such as obesity or a family history of diabetes, your doctor should check your blood sugar before you start taking SEROQUEL XR and also during therapy. If you develop symptoms of high blood sugar or diabetes, such as excessive thirst or hunger, increased urination, or weakness, contact your doctor. Complications from diabetes can be serious and even life threatening.
Increases in triglycerides and in LDL (bad) cholesterol and decreases in HDL (good) cholesterol have been reported with SEROQUEL XR. Your doctor should check your cholesterol levels before you start SEROQUEL XR and during therapy.
Weight gain has been reported with SEROQUEL XR. Your doctor should check your weight regularly.
Tell your doctor about any movements you cannot control in your face, tongue, or other body parts, as they may be signs of a serious condition called tardive dyskinesia (TD). TD may not go away, even if you stop taking SEROQUEL XR. TD may also start after you stop taking SEROQUEL XR.
Other risks include feeling dizzy or lightheaded upon standing, decreases in white blood cells (which can be fatal), or trouble swallowing. Tell your doctor if you experience any of these.
Before starting treatment, tell your doctor about all prescription and nonprescription medicines you are taking. Also tell your doctor if you have or have had low white blood cell count, seizures, abnormal thyroid tests, high prolactin levels, heart or liver problems, or cataracts. An eye exam for cataracts is recommended at the beginning of treatment and every 6 months thereafter.
Since drowsiness has been reported with SEROQUEL XR, you should not participate in activities such as driving or operating machinery until you know that you can do so safely. Avoid becoming overheated or dehydrated while taking SEROQUEL XR. Do not drink alcohol while taking SEROQUEL XR.
Tell your doctor if you are pregnant or intend to become pregnant. Avoid breast-feeding while taking SEROQUEL XR.
The most common side effects are drowsiness, dry mouth, constipation, dizziness, increased appetite, upset stomach, weight gain, fatigue, disturbance in speech and language, and stuffy nose.
Do not stop taking SEROQUEL XR without talking to your doctor. Stopping SEROQUEL XR suddenly may cause side effects.
This is not a complete summary of safety information. Please discuss the full Prescribing Information with your health care provider.
Approved Uses
SEROQUEL XR is a once-daily tablet approved in adults for (1) add-on treatment to an antidepressant for patients with major depressive disorder (MDD) who did not have an adequate response to antidepressant therapy; (2) acute depressive episodes in bipolar disorder; (3) acute manic or mixed episodes in bipolar disorder alone or with lithium or divalproex; (4) long-term treatment of bipolar disorder with lithium or divalproex; and (5) schizophrenia.