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FDA makes change to GBCA Medication Guide requirement
On December 19, 2017, the FDA issued a new Safety Announcement related to gadolinium-based contrast agents (GBCAs) administered for MRIs. One of the actions described in the announcement was the requirement that every patient be given a Medication Guide to read before receiving a GBCA. The Medication Guides for all GBCAs are now available. However, on May 16, 2018, the FDA issued an Update to the requirement that patients be given the Medication Guides prior to their MRIs.
It appears that the FDA has determined that, “hospital inpatients are not required to receive a Medication Guide unless the patient or caregiver requests it”.
Since most people are not aware that patients are retaining gadolinium from GBCAs administered for MRIs or that gadolinium is a toxic metal, they will not know to ask for a copy of the Medication Guide or that one even exists. That will result in a vulnerable population of patients not being fully-informed about the potential risk of gadolinium deposition in their brain, bones, skin, and other tissues.
As documented in the medical literature, patients in hospitals are at greater risk of having an acute kidney injury or AKI which can impair patients’ kidney function and potentially cause them to retain more gadolinium. I believe that patients in hospitals and/or their families should be informed about that risk and they should be given a Medication Guide for the GBCA that will be administered for any inpatient imaging procedures.
The following is the FDA’s May 16, 2018 Update – (more…)
Revised GBCA Product Labeling with Medication Guide is now available for all agents
As of April 26, 2018, the revised Product Labeling with the Medication Guide for all gadolinium-based contrast agents (GBCAs) were posted on the FDA’s website. The FDA announced on December 15, 2017, that it was requiring GBCA manufacturers to revise product labeling and create a Medication Guide for each GBCA. The purpose of the Medication Guide is to provide patients with information about gadolinium retention in the body so that they can make an informed decision before agreeing to have an MRI with contrast – an MRI with a gadolinium-based contrast agent. Gadolinium (Gd) is a toxic metal and any amount that remains in the brain and other parts of the body has the potential to have a harmful effect. While the linear GBCAs are the least stable, macrocyclic agents have been found to leave residual gadolinium in patients’ bodies as well. The long-term effects of gadolinium deposition are still unknown; however, research is ongoing.
The Medication Guide for each agent mentions “many doses of gadolinium medicines” as a possible risk factor. Gadolinium-based contrast agents are intravenously administered prescribed drugs that can have a toxic effect even after one dose of contrast. Currently, no one knows why some patients become symptomatic after having one or more MRIs with a GBCA, while others do not. However, it appears that everyone retains an unknown amount of gadolinium from each dose of a gadolinium-based contrast agent they receive.
Links to the new Product Labeling for each agent are provided below. (more…)
FDA’s response to GBCA Safety Issues – More warnings and a Medication Guide
On December 19, 2017, the FDA issued an update to its Drug Safety Communication regarding brain retention of gadolinium-based contrast agents (GBCAs) used for MRIs. Despite mounting evidence that GBCAs leave gadolinium in the brain, bones, and other tissues of all patients who undergo MRIs with contrast, the FDA has decided not to suspend the use of any GBCAs. This is in stark contrast to the actions taken by the European Medicine’s Agency and the U.K.’s Medicines and Healthcare Products Regulatory Agency. Those agencies suspended the use of the linear agents Magnevist, Omniscan, and OptiMark, while requiring changes to all GBCA product labeling. The Japanese Ministry of Health, Labour and Welfare restricted the use of non-specific linear GBCAs only to cases where there is no alternative and it also required changes to product labeling.
In its Safety Alert, the FDA acknowledged that “linear GBCAs result in more retention and retention for a longer time than macrocyclic GBCAs”. However, the FDA concluded that “the benefit of all approved GBCAs continues to outweigh any potential risks”. This action was taken despite “reports of adverse events involving multiple organ systems in patients with normal kidney function”.
In response to the issue of gadolinium retention, the FDA is requiring several actions to alert health care professionals and patients about gadolinium retention after an MRI using a GBCA. These include requiring a new patient Medication Guide for each agent, providing educational information that every patient will be asked to read before receiving a GBCA, and taking actions that can help minimize problems. The FDA is also requiring manufacturers of GBCAs to conduct human and animal studies to further assess the safety of gadolinium-based contrast agents. Product labeling for all GBCAs must be changed to include new warnings and precautions.
Each GBCA will have a patient Medication Guide with agent specific information, and content that is required for all gadolinium-based contrast agents; the Medication Guide for MultiHance and ProHance have recently been released. The Radiology Department of each institution will create educational handouts that every patient will be asked to read before signing the consent form for his or her MRI or MRA with a GBCA.
Patients must be fully-informed about potential risks. (more…)