[Posted 01/12/2022]
TOPIC: Buprenorphine: Drug Safety Communication - FDA warns about dental problems with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain
AUDIENCE: Dentistry, Anesthesiology, Patient, Health Professional, Pharmacy
ISSUE: The FDA is warning that dental problems have been reported with medicines containing buprenorphine that are dissolved in the mouth. The dental problems, including tooth decay, cavities, oral infections, and loss of teeth, can be serious and have been reported even in patients with no history of dental issues. Despite these risks, buprenorphine is an important treatment option for opioid use disorder (OUD) and pain, and the benefits of these medicines clearly outweigh the risks.
The FDA is requiring a new warning about the risk of dental problems be added to the prescribing information and the patient Medication Guide for all buprenorphine-containing medicines dissolved in the mouth.
For more information about this alert, click on the red button Read Alert below.
BACKGROUND: Buprenorphine was approved in 2002 as a tablet to be administered under the tongue to treat OUD. In 2015, buprenorphine was approved as a film to be placed inside the cheek to treat pain. The buprenorphine medicines that are associated with dental problems are tablets and films dissolved under the tongue or placed against the inside of the cheek.
RECOMMENDATIONS:
Patients
• Continue taking your buprenorphine medicine as prescribed; do not suddenly stop taking it without first talking to your health professional as it could lead to serious consequences. Suddenly stopping these medicines could cause you to become sick with withdrawal symptoms because your body has become used to the buprenorphine medicine, or to relapse to opioid misuse that could result in overdose and death.
• Patients using buprenorphine medicines dissolved in the mouth should take extra steps to help lessen the risk of serious dental problems. After the medicine is completely dissolved, take a large sip of water, swish it gently around your teeth and gums, and swallow. You should wait at least 1 hour before brushing your teeth to avoid damage to your teeth and give your mouth a chance to return to its natural state.
• Inform your health professional if you have a history of tooth problems, including cavities. Schedule a dentist visit soon after starting this medicine and inform your dentist that you are taking buprenorphine, and schedule regular dental checkups while taking this medicine. Your dentist can customize a tooth decay prevention plan for you. Notify both your health professional and your dentist immediately if you experience any problems with your teeth or gums.
Health Professionals
• Health professionals should be aware the benefits of buprenorphine medicines clearly outweigh the risks and are an important tool to treat OUD. When combined with counseling and other behavioral therapies, this comprehensive medication-assisted treatment approach is often the most effective way for treating OUD, and can help sustain recovery and prevent or reduce opioid overdose.
• Ask patients about their oral health history prior to prescribing treatment with a transmucosal buprenorphine medicine. These serious dental problems have been reported even in patients with no history of dental issues, so refer them to a dentist as soon as possible after starting transmucosal buprenorphine. Counsel patients about the potential for dental problems and the importance of taking extra steps after the medicine has completely dissolved, including to gently rinse their teeth and gums with water and then swallow. Patients should be advised to wait at least 1 hour before brushing their teeth. Dentists treating someone taking a transmucosal buprenorphine product should perform a baseline dental evaluation and caries risk assessment, establish a dental caries preventive plan, and encourage regular dental checkups.
Read more about the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication, at: https://reurl.cc/9OxR4V
美國FDA發布藥物安全警訊，使用口腔黏膜吸收之buprenorphine口溶劑型藥品有發生牙齒相關問題的通報，包含蛀牙、口腔感染和落齒，有些問題可能很嚴重，甚至可能發生在先前無牙齒相關問題病史的病人。儘管有此風險，buprenorphine仍是鴉片類物質使用疾患(又名鴉片類物質依賴/成癮。 opioid use disorder, OUD)和疼痛治療中的重要治療選擇，且使用這類藥品的益處明顯大於風險。
美國FDA要求針對所有經口腔黏膜吸收之buprenorphine口溶劑型藥品於仿單及病人用藥指南中增加有關牙齒問題相關風險的警訊。Buprenorphine於2002年於美國FDA核准舌下錠用於治療OUD；2015年，美國FDA核准buprenorphine口頰貼片之劑型治療疼痛。有牙齒問題相關風險的buprenorphine為此舌下錠或口頰貼片劑型。
建議：
病人：
1.請持續按照醫師處方使用buprenorphine；請勿在未經諮詢醫療專業人員前突然停止服用，因為可能會導致嚴重後果。因為當身體已習慣buprenorphine，突然停止使用此類藥物可能會導致戒斷症狀，或使得OUD再復發而濫用opioid藥物，導致藥品過量和死亡。
2.使用口腔黏膜吸收之buprenorphine口溶劑型藥品的病人，應額外注意以下事項，以降低嚴重牙齒問題的風險：藥物完全溶解後，需喝適量的水，用水輕漱牙齒和牙齦等處後吞嚥。應至少等待1小時後再刷牙，以免損壞牙齒，讓口腔有時間恢復自然狀態。
3.如果有牙齒問題（包括蛀牙）之病史，請告知醫療專業人員。開始使用此類藥品後，立即安排牙醫檢查，並告知牙醫目前正在使用buprenorphine，並在使用此藥時安排定期牙科檢查。牙醫可針對蛀牙制定預防計劃。若牙齒或牙齦出現任何問題，請立即通知醫療專業人員和牙醫。
醫療專業人員：
1.醫療專業人員應了解buprenorphine為治療 OUD 的重要藥品，使用buprenorphine的益處明顯大於風險。當結合諮詢和其他行為療法時，此綜合性藥物輔助治療通常為治療OUD最有效的方法，可幫助病人持續復原及預防或減少opioid類藥物過量。
2.在處方經口腔黏膜吸收之buprenorphine口溶劑型藥品進行病人治療前，請詢問病人的口腔健康史。因在沒有牙齒相關問題病史的病人中也有通報嚴重的牙齒相關不良反應，因此在開始使用口腔黏膜吸收之buprenorphine口溶劑型藥品後，應儘快將病人轉診給牙醫。告知病人潛在的牙齒問題及藥物完全溶解後需額外注意事項，包括用水輕漱牙齒和牙齦後吞嚥。應建議病人至少等待1小時後再刷牙。使用口腔黏膜吸收之buprenorphine口溶劑型藥品的病人，牙醫應進行服藥前的基本牙科評估和齲齒風險評估，制定齲齒預防計劃，並鼓勵定期進行牙科檢查。
更多相關訊息與連結請參考FDA網址：https://reurl.cc/9OxR4V
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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