Neurontin, Gralise, Horizant (gabapentin) and Lyrica, Lyrica CR (pregabalin): Drug Safety Communication - Serious Breathing Problems
AUDIENCE: Patient, Neurology, Pain Management, Pulmonology, Pharmacy
BACKGROUND: Gabapentin and pregabalin are FDA-approved for a variety of conditions, including seizures, nerve pain, and restless legs syndrome.
ISSUE: FDA is warning that serious breathing difficulties may occur in patients using gabapentin (Neurontin, Gralise, Horizant) or pregabalin (Lyrica, Lyrica CR) who have respiratory risk factors. These include the use of opioid pain medicines and other drugs that depress the central nervous system, and conditions such as chronic obstructive pulmonary disease that reduce lung function. The elderly are also at higher risk.
FDA is requiring new warnings about the risk of respiratory depression to be added to the prescribing information of the gabapentinoids. FDA has also required the drug manufacturers to conduct clinical trials to further evaluate their abuse potential, particularly in combination with opioids, because misuse and abuse of these products together is increasing, and co-use may increase the risk of respiratory depression.
RECOMMENDATION: Patients and caregivers should seek medical attention immediately if you or someone you are caring for experiences symptoms of respiratory problems, because these can be life-threatening. Symptoms to watch for include:
• Confusion or disorientation
• Unusual dizziness or lightheadedness
• Extreme sleepiness or lethargy
• Slowed, shallow, or difficult breathing
• Unresponsiveness, which means a person doesn't answer or react normally or you can't wake them up
• Bluish-colored or tinted skin, especially on the lips, fingers, and toes
Always inform your health care professional about all the drugs you are taking, including prescription and over-the-counter medicines and other substances such as alcohol.
Health care professionals should start gabapentinoids at the lowest dose and monitor patients for symptoms of respiratory depression and sedation when co-prescribing gabapentinoids with an opioid or other central nervous system depressant such as a benzodiazepine.
Read more about the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication, at:
https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-serious-breathing-problems-seizure-and-nerve-pain-medicines-gabapentin-neurontin?utm_campaign=FDA%20MedWatch%20-%20gabapentin%20and%20pregabalin%29%3A%20Drug%20Safety%20Communication&utm_medium=email&utm_source=Eloqua
Gabapentin and pregabalin已經美國FDA核准用於癲癇、神經痛以及不寧腿症候群（restless legs syndrome）。近期美國FDA發布藥物安全警訊，具有呼吸相關危險因子的病人使用gabapentin（商品名Neurontin, Gralise, Horizant）或pregabalin（商品名Lyrica, Lyrica CR）可能會出現嚴重的呼吸困難。這些危險因子包含使用opioid類止痛藥和其他可抑制中樞神經系統的藥物，以及降低肺功能的相關疾病，如慢性阻塞性肺病。老年人亦有較高之風險。
美國FDA要求此有關呼吸抑制風險之新警語加入此類藥品仿單中，另要求廠商進行臨床試驗，以進一步評估藥物濫用的可能性，尤其是與opioid類藥物併用時。因為這類藥品的誤用和濫用有增加的趨勢，且併用可能會增加呼吸抑制的風險。
如果病人出現呼吸道症狀，則病人及其照護者應立即尋求醫療協助，因為這些症狀可能危及生命。要注意的症狀包括：
1. 意識混亂或搞不清楚人時地。
2. 不尋常的頭暈或頭重腳輕。
3. 極度嗜睡。
4. 呼吸緩慢，或呼吸困難。
5. 反應遲鈍，代表無法正常回答或做出反應，或者病人無法喚醒。
6. 皮膚呈現藍色或顏色改變，尤其是嘴唇，手指和腳趾。
且需將正在服用的所有藥物告知醫療專業人員，包括處方藥、非處方藥以及喝酒等情形。
醫療專業人員應以最低劑量開始使用gabapentin類藥物，並在與opioid類藥物或其他中樞神經抑制劑（例如benzodiazepine類藥物）併用時，監測病人的呼吸抑制和鎮靜症狀。
更多相關訊息與連結請參考FDA網址：https://reurl.cc/1xQ1b8
[Posted 12/19/2019]
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
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