WHO Pharmaceuticals Newsletter
(No. 5, 2009)
This issue records, in addition to other regulatory news, the revision to the package information for antidepressants in Japan; an approval for the use of colchicine in familial Mediterranean fever in the United States of America; and updated safety information for mycophenolic acid. The risk of hearing impairment with isotretinoin, a review of the abnormal behaviour and sudden death with oseltamivir and an increased risk of bleeding with warfarin and aspirin combination are some of the issues discussed under Safety of Medicines. Under Feature there are three items: a brief note on a newly-funded three year project in New Zealand, to scope and pilot a medication error reporting and prevention system; a brief review of reports of acute generalized exanthematous pustulosis (AGEP) with paracetamol in the WHO database for a potential signal;and a summary of adverse drug reaction reports in Sweden with influenza A (H1N1) vaccine.
Several regulatory authorities have licensed H1N1 swine flu pandemic vaccines for their countries. WHO advises all countries administering these vaccines to conduct intensive monitoring for their safety and to report all adverse events. The WHO Collaborating Centre for International Drug Monitoring, the Uppsala Monitoring Centre (UMC) and Swissmedic (Swiss Agency for Therapeutic Products) have developed a new software tool, PaniFlow, for reporting adverse events following immunization. For additional details of this tool visit the UMC website at www.who-umc.org