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EMA Issues Final Opinion Limiting Gadolinium Contrast Agents in Body Scans

(29.07.2017)


The European Medicines Agency (EMA) has concluded its scientific review of of gadolinium deposition in brain and other tissues, confirming recommendations to restrict the use of some linear gadolinium contrast agents used in MRI body scans and suspend the authorisations of others.


The recommendations – confirmed by EMA’s Committee for Medicinal Products for Human Use (CHMP) – follow a review that found that gadolinium deposition occurs in brain tissues following use of gadolinium contrast agents.

While there is currently no evidence that gadolinium deposition in the brain has caused any harm to patients, EMA has however recommended restrictions for some intravenous linear agents in order to prevent any risks that could potentially be associated with gadolinium brain deposition.

The intravenous linear agents gadoxetic acid and gadobenic acid can continue to be used for liver scans because they are taken up in the liver and meet an important diagnostic need. In addition, gadopentetic acid given intra-articularly (into the joint) can continue to be used for joint scans because the dose of gadolinium used for joint injections is very low.

All other intravenous linear products (gadodiamide, gadopentetic acid and gadoversetamide) should be suspended in the EU.

Another class of gadolinium agents known as macrocyclic agents (gadobutrol, gadoteric acid and gadoteridol) are more stable and have a lower propensity to release gadolinium than linear agents. These products can continue to be used in their current indications but in the lowest doses that enhance images sufficiently and only when unenhanced body scans are not suitable.

The suspensions or restrictions on linear agents can be lifted if the companies concerned provide evidence of new benefits in an identified patient group that outweigh the risk of brain deposition or if the companies can modify their products so they do not release gadolinium significantly or cause its retention in tissues.

EMA’s scientific review of gadolinium deposition in brain and other tissues is now concluded. The final recommendations will be sent to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.


Product

Type (formulation)

Recommendation

Artirem / Dotarem (gadoteric acid)

 macrocyclic (i.v.)

 maintain

Artirem / Dotarem (gadoteric acid)

 macrocyclic (intra- articular)

 maintain

Gadovist (gadobutrol)

 macrocyclic (i.v.)

 maintain

Magnevist (gadopentetic acid)

 linear (i.v.)

 maintain

Magnevist (gadopentetic acid)

 linear (i.v.)

 suspend

Multihance (gadobenic acid)

 linear (i.v.)

 restrict use to liver scans

Omniscan (gadodiamide)

 linear (i.v.)

 suspend

Optimark (gadoversetamide)

 linear (i.v.)

 suspend

Primovist (gadoxeticacid)

 linear (i.v.)

 maintain

Prohance (gadoteridol)

 macrocyclic (i.v.)

 maintain

Source: EMA Press Release



Related information

EMA: Gadolinium-containing contrast agents
EMA: July 21, 2017: EMA’s final opinion confirms restrictions on use of linear gadolinium agents in body scans
EMA: July 7, 2017: PRAC confirms restrictions on the use of linear gadolinium agents
EMA: March 10, 2017: PRAC concludes assessment of gadolinium agents used in body scans and recommends regulatory actions, including suspension for some marketing authorisations
EMA: March 8, 2016: PRAC reviews gadolinium contrast agents used in MRI scans

FDA: Information on Gadolinium-Based Contrast Agents
FDA: July 27, 2015: FDA evaluating the risk of brain deposits with repeated use of gadolinium-based contrast agents for magnetic resonance imaging (MRI)


Related EVISA Resources

Brief summary: Speciation analysis for the study of metallodrugs and their biomolecular interactions
Link Database: Toxicity of Gadolinium compounds
Link Database: Use of Gadolinium in pharmaceuticals
Materials Database: Gadolinium Materials
Link page: All about Mass Spectrometry: Resources related to Mass Spectrometry


Related EVISA News

May 23, 2017: FDA identifies no harmful effects to date with brain retention of gadolinium-based contrast agents for MRIs
March 11, 2017: European Medicines Agency recomments to pull linear Gadolinium-based MRI contrast agents from market 
April 10, 2016: New Studies Question Safety of MRI Contrast Agents
August 13, 2015: FDA investigating risk of gadolinium contrast agent brain deposits
March 4, 2015: Detection of Gd-based contrast agent in the skin of a patient eight years after administration
October 29, 2012: Identification and quantification of potential metabolites of Gd-based contrast agents 
September 15, 2010: US FDA Announces Gadolinium-Based MRI Contrast Agent Warning
March 25, 2010: Publication on the separation of Gd-based contrast agents awarded
May 4, 2009: Gadolinium speciation analysis in search for the cause of nephrogenic systemic fibrosis (NSF)

last time modified: July 29, 2017




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