礼来公司近日宣布，FDA已批准其产品Cymbalta（duloxetine HCl，盐酸度洛西汀）作为成人抑郁症患者的维持治疗药物。大脑里和脊髓里的复合胺和肾上腺素对抑郁症患者的情绪和人体疼痛的感知都具有调节作用，而前临床试验结果显示，度洛西汀（duloxetine）是有效增强中枢神经系统复合胺和肾上腺素活动性的一种再摄取抑制剂。度洛西汀的作用机理还不完全知晓，科学家认为它治疗抑郁症、焦虑症和疼痛感知时，是通过上述方式起作用。

礼来公司相关负责人称，在抑郁症成功治疗之后出现病情复发在临床上是一个主要问题，这次Cymbalta通过FDA批准极为重要，因为临床数据表明，该药可以延长病情复发的时间。

Cymbalta作为抑郁剂维持治疗药物的疗效和安全性在一项双盲安慰剂控制临床试验中得到了证实。在试验中，533名受试者每天使用60毫克Cymbalta进行治疗，12周之后，其中278例达到进入持续治疗期的标准。在之后的6个月内，这些患者随机分组，分别使用同等剂量的Cymbalta或安慰剂继续进行治疗。结果显示，与安慰剂对照组相比较，Cymbalta受试组病情复发时间延长。在试验中，这种药物常见的副作用为恶心呕吐。

之前，该药已获准作为抑郁症的紧急治疗药，并获准治疗糖尿病神经性疼痛和广泛性焦虑症。到目前为止，美国已有900万名成人患者采用这种药物进行治疗。

Cymbalta Side Effects

Cymbalta, generic name Duloxetine Hydrochloride, has certain side effects consumers should be aware of.

Cymbalta manufactured by Eli Lilly is a serotonin norepinephrine reuptake inhibitor (SNRI) antidepressant used to treat major depression. It is prescribed to treat pain associated with diabetic peripheral neuropathy, which is a painful nerve disorder associated with diabetes that affects the hands, legs, and feet. Cymbalta has only recently been approved for use to treat fibromyalgia if people can tolerate Cymbalta’s side effects.

The drug works by preventing serotonin and noradrenaline from being reabsorbed back into the nerve cells in the brain. This helps prolong the mood-lightening effect of any released serotonin and noradrenaline, restoring balance to the emotions of the patient. Cymbalta may also be used in the treatment of generalized anxiety disorder.

Among the more common Cymbalta side effects that users complain about is being fatigued even after a good night’s sleep. Blurred vision, dry mouth, nausea, vomiting, and issues with both constipation and diarrhea, agitation, irritability, increased, hostility, high blood pressure, decreased libido, hot flashes, fatigue, rash, and increased sweating have also been reported.

While people say many of Cymbalta’s side effects are manageable, some users experience effects that are extremely frightening and potentially dangerous. Some patients found the drug tends to trigger heart palpitations and increase anxiety levels and elevate the severity suicidal thoughts or impulses.

A 19-year-old college student who had shown no outward signs of depression killed herself at an Eli Lilly & Company laboratory in Indianapolis where she had been participating in a company drug trial for the experimental antidepressant. Four other patients who were given the drug during earlier trials also committed suicide.

Anyone taking Cymbalta should understand that they can be at risk while driving, handling machines, or performing other hazardous activities such as working on tall ladders as it can cause dizziness or drowsiness.

Many people report that there were no Cymbalta side effects except for a lowered sexual drive and feel the drug gave them back their life. Like other antidepressants, Cymbalta should not be stopped suddenly if you have been on it for some time. Your brain receptors will adjust to it, and suddenly stopping can cause crying jags, agitation, dizziness, nausea, or headache. You should always talk with your doctor or healthcare provider to work out a plan to slowly decrease your medication to avoid withdrawal symptoms.

People are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.