European Medicines Agency News: big data, gadolinium contrast agents and docetaxel
Big data workshop
On 14 and 15 November 2016, the European Medicines Agency (EMA) organised a Big data workshop. The objective of this workshop was to increase understanding of how big data will impact on our understanding of disease and facilitate medicines development, so that the regulatory community can identify opportunities and address challenges in its use for medicines decision-making.
In his opening remarks, Professor Guido Rasi (Executive Director, EMA) emphasised the clear potential of big data to benefit patients. While collection and use of data come with the responsibility to ensure security and protect patient privacy, patient groups expressed their willingness to share data in the knowledge that it advances research and ultimately helps other patients.
Privacy, security and transparency were overarching themes of the workshop. Frank and transparent exchange with patients and the public about how their data are used, how their privacy is protected and the potential benefits of data sharing must underpin projects to ensure success. Workshop participants emphasised that patients and the public appreciate the value of sharing their data and that patients and patient groups play a pivotal role, not only in consenting to data use, but also in proactively driving data capture and providing informative patient perspectives.
The full report of the workshop can be found on the European Medicines Agency website.
Gadolinium contrast agents
The European Medicine Agency’s Pharmacovigilance and Risk Assessment Committee has recommended the suspension of the marketing authorisations for four linear gadolinium contrast agents, because of evidence that the small amounts of the gadolinium they contain are deposited in the brain.
The agents concerned were given to some patients to enhance images from magnetic resonance imaging (MRI) body scans. There is convincing evidence of accumulation of gadolinium in the brain of some patients.
Although no symptoms or diseases linked to gadolinium in the brain have been reported, the Pharmacovigilance and Risk Assessment Committee took a precautionary approach. Deposition of gadolinium in other organs and tissues has been associated with rare side effects and non-clinical laboratory studies have shown that gadolinium can be harmful to tissues.
IMPORTANT UPDATE of 13 July 2017:
EMA's Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed its previous conclusion from March 2017 that there is convincing evidence of gadolinium deposition in brain tissues following use of gadolinium contrast agents.
No specific conditions linked to gadolinium deposition in the brain have been identified, but the clinical consequences are unknown.
As a result of the review, the PRAC recommends that the intravenous linear agents gadoxetic acid and gadobenic acid should only be used for liver scans in the situations where they meet an important diagnostic need. In addition, gadopentetic acid should only be used for joint scans as the gadolinium concentration in the formulation used for joint injections is very low.
All other intravenous linear agents (gadodiamide, gadopentetic acid and gadoversetamide) should be suspended in line with the PRAC's March 2017 recommendation.
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 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 PRAC's recommendation will now be sent to the Committee for Medicinal Products for Human Use (CHMP), which will adopt the Agency's final opinion.
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The European Medicines Agency is investigating the cancer medicine docetaxel following cases of neutropenic enterocolitis in patients in France, most of whom were being treated for breast cancer. Neutropenic enterocolitis is a serious inflammatory condition of the intestine associated with low levels of neutrophils, a type of white blood cell. It is a known and rare side effect of docetaxel (which may affect up to one in 10,000 people).
A preliminary assessment by the European Medicines Agency's Pharmacovigilance Risk Assessment Committee indicates that the frequency of this side effect has not increased in the last two years. A thorough evaluation of available data is being carried out and final conclusions will be published once the review is completed.
Docetaxel is an important therapeutic option which has been shown to extend the lives of cancer patients. While the review is ongoing, the European Medicines Agency advises that doctors should continue to prescribe this medicine according to recommendations in the current product information, including detailed recommendations for the prevention and management of neutropenia.