藥物警訊（藥師週刊 第1719期）

including Haldol, FazaClo, Fanapt, Clozaril, Risperdal, Zyprexa, Seroquel, Abilify, Geodon, Invega, Loxitane, Moban, Navane, Orap, Saphris, Stelazine, Thorazine, Symbyax

AUDIENCE: Psychiatry, OBGYN

FDA notified healthcare professionals that the Pregnancy section of drug labels for the entire class of antipsychotic drugs has been updated. The new drug labels now contain more and consistent information about the potential risk for abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of pregnancy.

The symptoms of EPS and withdrawal in newborns may include agitation, abnormally increased or decreased muscle tone, tremor, sleepiness, severe difficulty breathing, and difficulty in feeding. In some newborns, the symptoms subside within hours or days and do not require specific treatment; other newborns may require longer hospital stays.

BACKGROUND: Antipsychotic drugs are used to treat symptoms of psychiatric disorders such as schizophrenia and bipolar disorder.

RECOMMENDATION: Healthcare professionals should be aware of the effects of antipsychotic medications on newborns when the medications are used during pregnancy. Patients should not stop taking these medications if they become pregnant without talking to their healthcare professional, as abruptly stopping antipsychotic medications can cause significant complications for treatment.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

* Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
* Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

FDA提醒醫護人員已更新所有抗精神病藥品仿單中懷孕方面的資料，更新的仿單中包含關於懷孕第三期使用抗精神病藥品產下之新生兒可能有不正常肌肉活動(椎體外症候群的症狀)的潛在風險及戒斷症狀。症狀包含激動、肌肉張力不正常增加或減少、顫抖、想睡、嚴重呼吸困難及進食困難，某些新生兒的症狀會在數小時或數天內消失而無須特別治療，有些新生兒則可能需要延長住院。

醫護人員應知道抗精神病藥品在懷孕期使用對新生兒的影響，原本有服用抗精神病藥品的病人若發現懷孕，在未告知醫師的情況下不應停藥，因為突然停藥可能會造成明顯的併發症。

相關訊息與連結請參考FDA網址：
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...
[Posted 02/22/2011]

Extenze Tablets: Recall

AUDIENCE: Consumer

FDA notified Biotab Nutraceuticals, Inc. that two lots of counterfeit product purporting to be Extenze contain undeclared drug ingredients. Specifically, lot 0709241 contains tadalafil and sildenafil, and lot 0509075 contains tadalafil and sibutramine.

Tadalafil and sildenafil are drugs used to treat erectile dysfunction (ED). These drugs may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek Extenze to enhance sexual performance.

Sibutramine is a controlled substance that was withdrawn from the market in October 2010 for safety reasons. Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.

BACKGROUND: The counterfeit products are sold at retail nationwide in the form of carded four-packs (lot 0709241) and in the form of a box of thirty tablets divided into two fifteen tablet blister packs (lot 0509075). It is possible that there may be other counterfeit products on the market that have yet to be identified.

RECOMMENDATION: Consumers in possession of product from the lots in question only should return any unused product.

Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

* Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
* Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the company press release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

FDA通知Biotab Nutraceuticals公司，有兩批偽造的產品號稱Extenze，而內含未標示的成分，批號0709241的產品含有tadalafil及 sildenafil，批號0509075的產品則是含有tadalafil及sibutramine。

Tadalafil及sildenafil是用來治療男性勃起功能障礙，可能會與nitrates類的藥物如nitroglycerin發生藥物交互作用，而造成血壓降低至危險的程度，糖尿病人、高血壓、高血脂或心臟疾患的消費者常使用nitrates類的藥物，而勃起功能障礙亦常見於這類男性病人，可能同時使用改善性功能的產品如Extenze而發生危險。

Sibutramine基於安全考量已於2010年10月下市，已知sibutramine會使部分病人血壓脈搏大幅增加，可能對有冠狀動脈疾病、鬱血性心衰竭、心律不整或中風病史的病人有顯著的危險。

偽造的產品已銷售至全美的零售店，批號0709241的產品為4錠片裝，批號0509075的產品為15錠片裝，1盒2片共30錠，此外，可能還有其他偽藥流通市面而仍未發現。FDA建議持有問題批號產品的消費者應立即退回。

相關訊息與連結請參考FDA網址：
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm244369.htm
[Posted 02/23/2011]

資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部