Gadolinium-based Contrast Agents for Magnetic Resonance Imaging (MRI): Drug Safety Communication - No Harmful Effects Identified With Brain Retention
Including:
Ablavar (gadofosveset trisodium)
Dotarem (gadoterate meglumine)
Eovist (gadoxetate disodium)
Gadavist (gadobutrol)
Magnevist (gadopentetate dimeglumine)
MultiHance (gadobenate dimeglumine)
Omniscan (gadodiamide)
OptiMARK (gadoversetamide)
ProHance (gadoteridol)
AUDIENCE: Radiology
ISSUE: An FDA review to date has not identified adverse health effects from gadolinium retained in the brain after the use of gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI). All GBCAs may be associated with some gadolinium retention in the brain and other body tissues. However, because FDA identified no evidence to date that gadolinium retention in the brain from any of the GBCAs, including GBCAs associated with higher retention of gadolinium, is harmful, restricting GBCA use is not warranted at this time. FDA will continue to assess the safety of GBCAs and plan to have a public meeting to discuss this issue in the future.
FDA evaluated scientific publications and adverse event reports submitted to FDA. Some human and animal studies looked at GBCA use over periods longer than a year. These publications and reports show that gadolinium is retained in organs such as the brain, bones, and skin. The publications show that linear GBCAs retain more gadolinium in the brain than macrocyclic GBCAs. However, the review did not identify adverse health effects related to this brain retention.
FDA continues to assess the safety of GBCAs. FDA's National Center for Toxicological Research is conducting a study on brain retention of GBCAs in rats. Other research is also being conducted about how gadolinium is retained in the body. FDA will update the public when new information becomes available and we plan to have a public meeting to discuss this issue in the future.
BACKGROUND: Gadolinium-Based Contrast Agents are intravenous drugs used in diagnostic imaging procedures to enhance the quality of magnetic resonance imaging or magnetic resonance angiography.
RECOMMENDATION: FDA recommendations for health care professionals and patients remain unchanged from July 2015 when FDA informed the public that FDA was investigating this potential risk with GBCAs. As is appropriate when considering the use of any medical imaging agent, health care professionals should limit GBCA use to circumstances in which additional information provided by the contrast agent is necessary, and assess the necessity of repetitive MRIs with GBCAs. Patients, parents, and caregivers should talk to their health care professionals if they have any questions or concerns about the use of GBCAs with MRIs. Retention of gadolinium affects only GBCAs, and does not apply to other types of scanning agents used for other imaging procedures, such as those that are iodine-based or radioisotopes.
Read the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication, at:
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm559709.htm
含釓(gadolinium)類顯影劑為用於影像診斷(例如：核磁共振(magnetic resonance imaging, MRI)或核磁共振血管造影(magnetic resonance angiography))之靜脈注射藥品。美國FDA回顧相關科學文獻與藥物不良反應通報系統，其資料顯示所有含gadolinium類顯影劑皆可能會殘留於腦部、骨頭或皮膚等身體組織，並依據結構的不同其殘留於體內的量也不同，線性結構之含gadolinium類顯影劑殘留gadolinium於腦部較環狀結構高。然而這些文獻皆無法確定gadolinium殘留於腦部對健康是否有危害，因此目前未限制gadolinium的使用。美國FDA會持續評估含gadolinium類顯影劑之安全性。若有更進一步的資訊，會再發布相關公告。
醫療專業人員使用含gadolinium類顯影劑應侷限於必須使用顯影劑以提供額外資訊供診斷之情況下，且再次使用含gadolinium類顯影劑於MRI時也需評估其必要性。病人或病人家屬若對於含gadolinium類顯影劑有疑慮應與醫療專業人員溝通。然而含gadolinium類顯影劑可能會殘留在體內的相關資訊，並不適用於其他協助診斷的顯影藥品(例如：含碘顯影劑或放射線藥品)。
相關訊息與連結請參考FDA網址：
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm559709.htm
[Posted 05/22/2017]
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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