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【drug-news】FDA 警告常用 Epilepsy 药有行为异常和自
Thursday January 31, 4:51 pm ET
FDA Warns of Suicide Risk With Epilepsy Drugs
WASHINGTON (AP) -- Epilepsy drugs used by millions of people may increase the risk of suicidal thoughts or behavior, the Food and Drug Administration warned in an alert to doctors Thursday.
The FDA analyzed almost 200 studies of 11 different anti-seizure drugs, some that have been on the market for decades. The studies tracked almost 28,000 people given the medications and another 16,000 given dummy pills.
Very rarely were suicidal thoughts or behavior reported. Still, the FDA found drug-treated patients did face about twice the risk: 0.43 percent of drug-treated patients experienced suicidal thoughts or behavior compared with 0.22 percent of placebo-takers.
Overall, four people in the drug-treated groups committed suicide, and none in the placebo groups.
What that means: For every 1,000 patients, about two more drug-treated patients experienced suicidal thoughts than placebo-takers, FDA concluded.
Anti-seizure drugs are used for a variety of illnesses in addition to epilepsy, including migraines, certain nerve-pain disorders, and psychiatric diseases such as bipolar disorder that themselves carry a risk of suicide.
The FDA found drug-treated patients were at increased risk no matter their diagnosis, but that the risk was highest for epilepsy sufferers.
The FDA began investigating if epilepsy drugs pose any suicide risk in 2005. It analyzed data from 11 well-known anti-seizure drugs including Pfizer Inc.'s Neurontin, Novartis AG's Tegretol and Abbott Laboratories' Depakote -- but the FDA said it expected that the risk applied to every epilepsy drug. The FDA said it would work with manufacturers to add the warning to product labels.
The FDA did not respond to requests for comment about how patients should interpret the warning.
But the agency's letter to doctors advised them to:
--Balance the risk with the patients' need for the drug.
--Tell patients and their families about the risk so they can be aware of changes in mood.
--Make sure patients and families know to contact a doctor if someone experiences common suicide warning signs, such as talking or thinking about hurting yourself, becoming preoccupied with death, withdrawal, becoming depressed or worsening depression, and giving away prized possessions. 认领,48小时 FDA Warns of Epilepsy Drugs Risk
Thursday January 31, 4:51 pm ET
FDA Warns of Suicide Risk With Epilepsy Drugs
FDA对抗癫痫药物风险提出警告
美国东部时间1月31日星期四下午4:51
FDA警告抗癫痫药物增加自杀风险
WASHINGTON (AP) -- Epilepsy drugs used by millions of people may increase the risk of suicidal thoughts or behavior, the Food and Drug Administration warned in an alert to doctors Thursday.
华盛顿(AP)- 食品和药品管理局于周四提醒医生注意被数百万人使用的抗癫痫药物可能增加自杀念头或行为风险。
The FDA analyzed almost 200 studies of 11 different anti-seizure drugs, some that have been on the market for decades. The studies tracked almost 28,000 people given the medications and another 16,000 given dummy pills.
FDA对11种不同的抗癫痫发作药物进行了几乎200项研究，某些已经上市数十年。该研究追踪了几乎28,000名服用该类药物的患者患者以及另外16,000名服用安慰剂的患者。
Very rarely were suicidal thoughts or behavior reported. Still, the FDA found drug-treated patients did face about twice the risk: 0.43 percent of drug-treated patients experienced suicidal thoughts or behavior compared with 0.22 percent of placebo-takers.
尽管有关自杀性念头或行为的报道极少。但是FDA发现药物治疗的患者所面临的风险大约为服用安慰剂的患者的2倍：药物治疗的患者中有0.43%产生过自杀念头或行为，而服用安慰剂的患者为0.22%。
Overall, four people in the drug-treated groups committed suicide, and none in the placebo groups.
总体上，药物治疗组中有4名患者自杀，而安慰剂组无一例自杀。
What that means: For every 1,000 patients, about two more drug-treated patients experienced suicidal thoughts than placebo-takers, FDA concluded.
那意味着：FDA据此得出结论认为对于每1,000患者而言，经过大约2种以上药物治疗的患者的自杀念头超过服用安慰剂的患者。
Anti-seizure drugs are used for a variety of illnesses in addition to epilepsy, including migraines, certain nerve-pain disorders, and psychiatric diseases such as bipolar disorder that themselves carry a risk of suicide.
除癫痫患者外，抗癫痫发作药物尚用于各种疾病的治疗，包括偏头痛、某些神经性疼痛疾病以及精神病，如本身就具有自杀性风险的躁狂症。
The FDA found drug-treated patients were at increased risk no matter their diagnosis, but that the risk was highest for epilepsy sufferers.
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作者:admin@医学,生命科学 2011-03-26 17:14
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