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The ministerial forum made some progress at its meeting late last month, splitting its consideration of palm oil from other labelling changes.
In early 2012, the FDA issued labelling changes for statin drugs based on updated safety information.
4 5 6 Because a causal relation between isotretinoin and psychiatric reactions was difficult to exclude, labelling changes strengthening warnings about psychiatric adverse reactions have been added in product information for isotretinoin products within the EU despite contradictory evidence.
14 We report the results of an EMA-commissioned study on the impact of labelling changes and findings reported in scientific publications on the utilisation of rosiglitazone-containing products in Europe.
This along with a social marketing campaign and labelling changes to target behaviour change to reduce salt intake achieved a 15%% reduction from 9.5 to 8.1 g/day over 10 years [ 30].
US research on the UMS has also shown positive results, but much of the published literature is focussed around labelling changes as well as the simplification of medicine regimens in to a chart.
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But labeling changes may not work.
Already, some labeling changes are under way.
Word of the label changes, however, had not been made public before Wednesday's hearing.
But they said label changes alone could not solve the complex problem of medication errors.
A spokeswoman for the agency, Sandy Walsh, said she could not comment on the label changes.
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