藥物警訊

Olanzapine: Drug Safety Communication - FDA Warns About Rare But Serious Skin Reactions

Including Zyprexa, Zyprexa Zydis, Zyprexa Relprevv, and Symbyax

AUDIENCE: Psychiatry, Dermatology, Patient

ISSUE: FDA is warning that the antipsychotic medicine olanzapine can cause a rare but serious skin reaction that can progress to affect other parts of the body. FDA is adding a new warning to the drug labels for all olanzapine-containing products that describes this severe condition known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).

A search of the FDA Adverse Event Reporting System (FAERS) database identified 23 cases of DRESS reported with olanzapine worldwide since 1996, when the first olanzapine-containing product was approved. FAERS includes only reports submitted to FDA, so there are likely to be additional cases about which FDA is unaware. One patient taking olanzapine experienced DRESS and died; however, this patient was taking multiple medicines that could also have contributed to death.

DRESS may start as a rash that can spread to all parts of the body. It can include fever and swollen lymph nodes and a swollen face. It causes a higher-than-normal number of infection-fighting white blood cells called eosinophils that can cause inflammation, or swelling. DRESS can result in injury to organs including the liver, kidneys, lungs, heart, or pancreas, and can lead to death. DRESS is a potentially fatal drug reaction with a mortality rate of up to 10%.

BACKGROUND: Olanzapine is an antipsychotic medicine used to treat mental health disorders schizophrenia and bipolar disorder. It can decrease hallucinations, in which people hear or see things that do not exist, and other psychotic symptoms such as disorganized thinking. Olanzapine is available under the brand names Zyprexa, Zyprexa Zydis, Zyprexa Relprevv, and Symbyax, and also as generics.

RECOMMENDATIONS: Patients taking olanzapine-containing products who develop a fever with a rash and swollen lymph glands, or swelling in the face, should seek medical care right away. The combined symptoms together are commonly seen in DRESS. Talk with your health care professional about any questions or concerns. Do not stop taking olanzapine or change your dose without first talking with your health care professional. Sudden stopping of the medicine can be harmful without your health care professional's direct supervision.

Health care professionals should immediately stop treatment with olanzapine if DRESS is suspected. There is currently no specific treatment for DRESS. The important ways to manage DRESS are early recognition of the syndrome, discontinuation of the offending agent as soon as possible, and supportive care. Treatment with systemic corticosteroids should be considered in cases with extensive organ involvement. When prescribing the medicine, explain the signs and symptoms of severe skin reactions to your patients and tell them when to seek immediate medical care.

Drug Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm500123.htm

美國FDA發布藥品安全警訊，抗精神病用藥olanzapine可能發生罕見但嚴重的皮膚不良反應，也可能進一步影響身體其他功能。美國FDA已新增Drug Reaction with Eosinophilia and Systemic Symptoms (簡稱DRESS) 相關警語至所有含olanzapine成分之藥品仿單。

Olanzapine為治療精神分裂症及躁鬱症之抗精神病藥物，可減少病人產生幻覺及如思維紊亂等其他精神症狀。此藥自1996年核准上市以來，美國不良事件通報資料庫（FAERS）中已接獲23起使用olanzapine後發生DRESS之案例（FAERS只包含有通報FDA的資訊，其餘潛在案例有可能更多），其中一名病人通報死亡，惟此病人同時使用多種藥品，故未能釐清是否與olanzapine有關。

DRESS一開始的症狀為紅疹，可能蔓延全身，同時也可能出現如發燒、淋巴及臉部腫脹，DRESS會使體內嗜伊紅性白血球異常增加，引起發炎或腫脹現象，導致肝、腎、肺、心或胰臟等器官損傷，為一種具有潛在致命風險的藥品不良反應，致死率可高達10%。

美國FDA提醒正在服用含有olanzapine成分藥品之病人若出現發燒伴隨皮膚紅疹、淋巴腺腫大或臉部腫脹，應立即就醫。在未與醫療人員連絡前請勿自行停藥或調整olanzapine劑量，未經醫療人員指示突然停藥可能會影響疾病治療及造成傷害。

美國FDA也提醒醫療人員於處方olanzapine時應告知病人可能會發生嚴重皮膚不良反應症狀及何時應立即就醫，若病人出現疑似DRESS症狀，應立即停止使用olanzapine。DRESS無特別的治療方法，應及早發現及早就醫，並立即停藥給予支持治療。若已出現廣泛性器官侵犯症狀，可考慮給予全身性的類固醇治療。

相關訊息與連結請參考FDA網址：
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm500123.htm

[Posted 05/10/2016]

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