Health professionals and consumers are advised that Roche Diagnostics Australia, after consultation with the TGA, has initiated a recall for product correction for its CoaguChek XS, CoaguChek XS Plus and CoaguChek XS Pro INR monitors
Bradycardia, often disregarded, and syncopes can be caused by acetylcholinesterase inhibitor drugs, used for Alzheimer dementia and not only
Traditional NSAIDs and coxib are not so different after all if gastrointestinal and cardiovascular adverse reactions are considered altogether
In order to understand and evaluate the potential risks associated with natural products, Italy since 2002 has activated a surveillance system for adverse reactions to these products, which is coordinated by Istituto Superiore della Sanità (ISS).1 At present the database contains 850 reports of adverse reactions to natural products. From the analysis of this database, 5 cases of hypoglycaemia caused by products containing lipoic acid have emerged (4 women and one man).
Intrahepatic bile ducts breakage
Do try and find someone asserting that information in pharmacovigilance is useless. I am sure you will not be very successful. Nevertheless, there are no clear indications on how and when these instruments for information and communication should be used. Even though the new European Regulation – within the Risk Management Plan - pledges for “educational” activities, you will definitely encounter several difficulties if looking for a more precise idea about what to do – or to expect – in regard to information or communication in pharmacovigilance.
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