藥物警訊

Aripiprazole (Abilify, AbilifyMaintena, Aristada): Drug Safety Communication - FDA Warns About New Impulse-control Problems

AUDIENCE: Psychiatry, Internal Medicine, Patient

ISSUE: FDA is warning that compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex have been reported with the use of the antipsychotic drug aripiprazole (Abilify, AbilifyMaintena, Aristada, and generics). These uncontrollable urges were reported to have stopped when the medicine was discontinued or the dose was reduced. These impulse-control problems are rare, but they may result in harm to the patient and others if not recognized.

Although pathological gambling is listed as a reported side effect in the current aripiprazole drug labels, this description does not entirely reflect the nature of the impulse-control risk FDA identified. In addition, FDA has become aware of other compulsive behaviors associated with aripiprazole, such as compulsive eating, shopping, and sexual actions. These compulsive behaviors can affect anyone who is taking the medicine. As a result, FDA is adding new warnings about all of these compulsive behaviors to the drug labels and the patient Medication Guides for all aripiprazole products.

BACKGROUND: Aripiprazole is used to treat certain mental disorders, including schizophrenia, bipolar disorder, Tourette's disorder, and irritability associated with autistic disorder. It may also be used in combination with antidepressants to treat depression. Aripiprazole can decrease hallucinations and other psychotic symptoms such as disorganized thinking. It can stabilize mood, improve depression, and decrease the tics of Tourette's disorder.

RECOMMENDATION: Health care professionals should make patients and caregivers aware of the risk of these uncontrollable urges when prescribing aripiprazole, and specifically ask patients about any new or increasing urges while they are being treated with aripiprazole. Closely monitor for new or worsening uncontrollable urges in patients at higher risk for impulse-control problems. These include those with a personal or family history of obsessive-compulsive disorder, impulse-control disorder, bipolar disorder, impulsive personality, alcoholism, drug abuse, or other addictive behaviors. Consider reducing the dose or stopping the medicine if such urges develop.

Patients and caregivers should be alert for uncontrollable and excessive urges and behaviors while taking aripiprazole. It is important to talk with a health care professional as soon as possible if you or a family member experiences any of these uncontrollable urges, in order to prevent or limit possible harm. Patients should not suddenly stop taking their aripiprazole medicine without first talking to their health care professional.

Read the MedWatch safety alert, including a link to the Drug Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm498823.htm

美國FDA發布藥品安全警訊，有關服用抗精神疾病藥品aripiprazole (Abililify, AbilifyMaintena, Aristada及其學名藥)後可能出現強迫性或無法控制之賭博、暴飲暴食、衝動購物、過度性行為之情形，美國FDA已接獲相關案例通報。以上案例之行為皆於停藥後或減低劑量後消失。衝動控制障礙雖不常見，但若未有警覺意識，可能對病人或他人造成傷害。

Aripiprazole為治療精神疾病如思覺失調症、躁鬱症、妥瑞氏症和自閉症之用藥，也會與其他抗憂鬱症藥品合併使用於憂鬱症之治療。Aripiprazole可減少瞻妄和其他如行為混亂之精神症狀，也可穩定情緒，改善憂鬱，減少妥瑞氏症之發作(tics)。

雖目前aripiprazole藥品仿單已將病態賭博(pathological gambling)列於其副作用欄位中，但無法完全呈現美國FDA認定的衝動控制障礙風險。由於此行為障礙可能影響任何一位正在服用此藥之病人，故美國FDA擬再新增其他與服用aripiprazole後可能出現之相關強迫行為之警語於藥品仿單及病人用藥指引內，如暴飲暴食、衝動購物及過度性行為等。

美國FDA建議醫療人員應提醒正在使用aripiprazole之病人及其照顧者留意發生這些無法控制的衝動行為風險，對於高風險病人，如個人或家族中具有強迫症、衝動控制障礙、躁鬱症、個人衝動行為，酗酒、藥物成癮、或其他成癮性行為之病史，更應特別詢問是否有出現任何新的或較以往嚴重的衝動行為，如有，應密切觀察及評估。若出現疑似症狀，應考慮減量或停藥。

服用此藥之病人及其照顧者應注意是否出現無法控制的衝動行為，若病人或其家人遇到任何類似症狀，應立即告知醫療人員。在未經醫療人員同意前，病人不應自行擅自停藥。

相關訊息與連結請參考FDA網址：

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm498823.htm

[Posted 05/03/2016]

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