Consent for Gadolinium
What kind of informed consent to you give your patients receiving gadolinium?
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Informed consent is grounded in the principle of patient autonomy — that individuals have the right to make informed decisions about their medical care based on a clear understanding of risks, benefits, and treatment alternatives. That said, healthcare providers commonly prescribe and administer medications (many more toxic than gadolinium contrast) without obtaining this high level of consent.
FDA-approved Medication Guide for Gadavist (gadobutrol). Click on image to enlarge.
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In 2017 the US Food and Drug Administration issued a Communication Warning requiring MR facilities to provide patients with a "Medication Guide", a 1-2 page summary of the potential risks of gadolinium contrast, including NSF, toxic effects of free gadolinium, and adverse reactions. Links to the FDA-approved Medication Guides approved for use in the USA can be found here. Searching for the text "gado" will bring up Guides for each of of the 8 FDA-approved agents. There is a slightly different Guide for each agent, though they are largely identical.
While I don't agree with all the statements contained in these FDA Medication Guides (such as the weakly substantiated claims that gadolinium contrast produces "pains, tiredness, skin, muscle, or bone ailments for a long time"), that is something we in the USA will have to live with for now.
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Below is a suggested consent form for gadolinium contrast administration that may be used in conjunction with the FDA Medication Guide. Ultimately, the final decision concerning the need and type of informed consent will be based on national or state regulations, society guidelines, and institutional or departmental policies.
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SAMPLE CONSENT FORM FOR
GADOLINIUM-BASED CONTRAST |
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Your health care provider has determined that an MRI study with gadolinium contrast is needed to help diagnose your medical condition. Gadolinium contrast is given by injection into a vein and aids in distinguishing normal from abnormal tissues.
The brand of gadolinium contrast you will receive (______________) has been determined to be safe and effective by the U.S. Food and Drug Administration (FDA). The attached Medication Guide has been approved by the FDA to help you understand some of the potential safety issues related to this drug. The MR technologist will review this Medication Guide with you and answer any questions you may have. As with any medication, a small chance exists that you may have a reaction to it. About 1 in 50 (2%) of patients will experience very minor and temporary side effects, including pain at the injection site, nausea, headache, dizziness, itching, rash, or hives. In about 1 in 5000 patients (0.05%), a true allergic reaction may occur (including facial swelling, difficulty breathing, or low blood pressure) requiring treatment. The odds of an extremely severe reaction is very rare — with the chance of death approximately 1:400,000 (0.00025%). Your odds of a reaction may be increased if you have had a previous allergic reaction to gadolinium, are allergic to other drugs or foods, have asthma, or suffer from kidney disease. Please inform the MR technologist if any of these situations apply to you. The use of gadolinium contrast is optional. However, your physician believes the potential diagnostic benefits for you exceed these small risks. By signing below you understand the statements above and agree to receive gadolinium contrast for your exam. X_________________________ (Patient/Legal Guardian) ___________ (Date) |
The decision to inform patients about the risk of NSF remains debated. Guidelines are provided by the American College of Radiology (ACR) in their most recent (2023) Manual on Contrast Media. When ACR Group II agents are used (gadoterate, gadobenate, gadobutrol, gadoteridol) the risk to patients even with impaired renal function is close to zero, so the ACR does not recommend informing patients about this possibility. However, NSF is listed on each of the eight Medication Guides, so the patients will see it. I personally feel it should be addressed in all patients, if only to dismiss it as exceedingly rare. Same with the theoretical risk of gadolinium accumulation.
References
ACR Committee on Drugs and Contrast Agents. ACR Manual on Contrast Agents, 2023. American College of Radiology 2022.
Berlin L. Informed consent for contrast media and gadolinium injections. AJR Am J Roentgenol 2011; 197:W359
Medication Guide for MultiHance (approved by the FDA Jan 2018)
Schema N, Maralani PJ, Hurrell C, et al. Updated clinical practice guideline on the use of gadolinium-based contrast agents in kidney disease issued by the Canadian Association of Radiologists. Can Assoc Radiol J 2019; 70:226-232. [DOI LINK]
US Food and Drug Administration Drug Safety Communication: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings. Issued 19 Dec 2017.
Weinreb JC, Rodby RA, Yee J, et al. Use of intravenous gadolinium-based contrast media in patients with kidney disease: Consensus statements fro the American College of Radiology and the National Kidney Foundation. Radiology 2021; 298:28-35. [DOI LINK]
Woolen SA, Shankar PR, Gagnier JJ, et al. Risk of nephrogenic systemic fibrosis in patients with Stage 4 or 5 chronic kidney disease receiving a Group II gadolinium-based contrast agent. A systemic review and meta-analysis. JAMA Intern Med 2020; 180:223-230. [DOI LINK] (Risk < 0.07%)
ACR Committee on Drugs and Contrast Agents. ACR Manual on Contrast Agents, 2023. American College of Radiology 2022.
Berlin L. Informed consent for contrast media and gadolinium injections. AJR Am J Roentgenol 2011; 197:W359
Medication Guide for MultiHance (approved by the FDA Jan 2018)
Schema N, Maralani PJ, Hurrell C, et al. Updated clinical practice guideline on the use of gadolinium-based contrast agents in kidney disease issued by the Canadian Association of Radiologists. Can Assoc Radiol J 2019; 70:226-232. [DOI LINK]
US Food and Drug Administration Drug Safety Communication: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings. Issued 19 Dec 2017.
Weinreb JC, Rodby RA, Yee J, et al. Use of intravenous gadolinium-based contrast media in patients with kidney disease: Consensus statements fro the American College of Radiology and the National Kidney Foundation. Radiology 2021; 298:28-35. [DOI LINK]
Woolen SA, Shankar PR, Gagnier JJ, et al. Risk of nephrogenic systemic fibrosis in patients with Stage 4 or 5 chronic kidney disease receiving a Group II gadolinium-based contrast agent. A systemic review and meta-analysis. JAMA Intern Med 2020; 180:223-230. [DOI LINK] (Risk < 0.07%)
Related Questions
What is NSF? How does gadolinium cause it?
What is NSF? How does gadolinium cause it?