Teva Parenteral Medicines of North Wales, PA, recently recalled six lots of Adrucil (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL) due to the potential presence of particulate matter identified as an aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.
Administration of an intravenous product with particulate matter has the potential to result in inflammation, allergic reactions, or blockage of blood vessels, leading to tissue death, which may be life-threatening if vital organs are affected.
Adrucil Injection is used in the palliative management of carcinoma of the colon, rectum, breast, stomach, and pancreas and is packaged in pharmacy bulk packages. The pharmacy bulk package has five 5 g/100ml vials per shelf pack. Individual Adrucil 5 g/100 ml vials have the NDC code 0703-3019-11 and the pharmacy shelf pack has the NDC code 0703-3019-12. The Adrucil 5 g/100 ml vial can be further identified by the statement on the label in red that states “PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION.”
Adrucil 5 g/100 ml vials were distributed in the United States. Teva has distributed this product nationwide through wholesalers, retailers, and pharmacies.
See also Medical Law Perspectives, May 2015 Report: Chemotherapy: Risks and Liabilities When the Treatment Is Toxic
The University of Valencia leads Focus, a European project with a budget of EUR 2.4 million until 2018, that aims to increase life expectancy in the European Union by two years over the coming decade and to create the first community-wide map of fragility to improve the quality of the population's ageing process.
The initiative, 60 percent funded by the third EU Health Programme and managed by the Consumers, Health, Agriculture and Food Executive Agency (CHAFEA), is coordinated by Professor Antonio Cano from the Department of Pediatrics, Obstetrics and Gynecology of the University of Valencia.
Cano, also head of the service for his area of expertise at Valencia University Hospital, claims that the European project Focus pursues collaboration between various action groups and the European Innovation Partnership on Active and Healthy Ageing (EIPAHA), since this Community platform is broadly represented by teams working on fragility.
'Our goal is to create mechanisms to be ahead of vulnerability to illness, or even of death,' explains Cano. Frailty, a recent concept in the area of health, refers to a state of weakness both against infections and against chronic cardiovascular, central nervous system or skeletal diseases, which 'may become a prelude to death,' says the researcher.
In fact, the Focus project is intended to look for substantiated quality indicators that can be used as references for the different population groups – taking account of both health and economic, cultural and geographical variables – and to promote lifestyles with less fragility in order to prevent non-communicable (i.e., non-transmissible) chronic illnesses. Furthermore, according to Professor Cano, 'we also want to have a bearing on health managers, patients' associations, sufferers, etc.'
According to the technical director of the European Projects Office at the University of Valencia, Àngels Sanchis, Focus is contributing to 'active and healthy ageing', one of the explicit objectives of the European Innovation Partnership on Active and Healthy Ageing, with a view to identifying interventions that can extend healthy life by two years in Europe by 2020, following the motto 'More years, better lives'.
Sanchis highlights the impact of Focus, which deals with population ageing as 'one of the social concerns in the European Union.' In addition, 'we hope that this research will lead to innovative, efficient and sustainable health care systems through the exchange of best practices, the use of existing data and strategies, the implementation of prevention programmes, the early diagnosis and the optimal management of patients,' she concludes.
The European project Focus will be organised into three main lines of action. First, there will be a phase of collection of information in order to establish standardised indicators. This will be followed by a sampling and an analysis of the needs of those affected by fragility, but also of the role that patients, doctors, social partners and political structures must play. And finally, the project will define actions to increase life expectancy in Europe by two years and will draw the first map of fragility in the European Union.
Focus will prepare clinical practice guides tailored to each environment in the European Union, according to various areas and taking into account, for example, that southern European countries (Spain, Portugal and Italy) have longer lifespans. Additionally, 'we will create a user-friendly technological platform to collect useful data for researchers and health managers,' says the professor.
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