prepared in collaboration with the WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden
The aim of this Newsletter is to disseminate information on the safety and efficacy of pharmaceutical products, based on information received from our network of "drug information officers" and other sources such as specialized bulletins and journals, as well as partners in WHO. The information is produced in the form of résumés in English, full texts of which may be obtained on request from:
Quality Assurance and Safety:
World Health Organization,
1211 Geneva 27, Switzerland
E-mail address: email@example.com
This newsletter is also available on our Internet website: http://www.who.int/medicines Further information on adverse reactions may be obtained from the WHO Collaborating Centre for International Drug Monitoring, Stora Torget 3, 753 20 Uppsala, Sweden
Issues around best pharmacovigilance practices and crisis management continue to occupy us even as the medical world struggles to understand the full picture with drugs such as the coxibs. Rofecoxib was withdrawn worldwide in September 2004 and in April 2005, the United States Food and Drug Administration asked Pfizer to voluntarily withdraw valdecoxib from the market. Several regulatory agencies have responded by issuing safety information and prescribing guidelines for various COX-2 inhibitors and these are presented in this edition.
The UN Prequalification Project was launched in 2001 for providing quality assessment on a selected number of medicines for high impact diseases that are considered for purchase by several UN agencies. We have included an overview of the team's work under 'Feature' and regular updates of products which have been prequalified by WHO will appear in future issues of the Newsletter.
The World Health Assembly will take place this year from 16 to 25 May, in Geneva. The WHO Collaborating Centre for International Drug Monitoring is holding its biennial training course on Pharmacovigilance from 23 May to 3 June in Uppsala, Sweden. For those of you who will attend either of these events, we hope they will provide opportunities and incentives for promoting health care and pharmacovigilance in your countries.
© World Health Organization 2005
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