WHO Drug Information articles from June 2007

WHO Drug Information archives from June 2007

Challenges of pharmacovigilance in Ukraine.(Pharmacovigilance Focus)
June 22, 2007... Assuring the safety of medicinal products is a key component of Ukraine's national medicines policy. Activities involving safety and monitoring of adverse reactions are part of a pharmacovigilance system operated by the State Pharmacological...

Adverse reaction reporting in Canada.(Pharmacovigilance Focus)(Health Professional Reporting of Adverse (Drug) Reactions by Health Canada)(Brief article)
June 22, 2007... Health Canada provides health professionals, consumers and patients with educational tools for reporting adverse reactions to drugs and other marketed health products, including prescription drugs; non-prescription drugs (including natural...

Educational modules for health professionals reporting adverse reactions.(Pharmacovigilance Focus)
June 22, 2007... Health Professional Reporting of Adverse Drug Reactions is a narrated, electronic (online) presentation to help health professionals recognize and report adverse reactions to Health Canada. Reporting adverse reactions contributes to: *...

A vital link in the patient safety chain.(Pharmacovigilance Focus)
June 22, 2007... After completing the learning modules and presentations, health professionals should be more knowledgeable about adverse reaction reporting and better able to: Describe an adverse reaction Associate adverse reaction reporting with...

WHO pharmacovigilance capacity building.(Pharmacovigilance Focus)(World Health Organization)
June 22, 2007... The WHO Programme for International Drug Monitoring is supporting a three-way approach to international pharmacovigilance training by providing: 1. Generic pharmacovigilance training for participants from different parts of the world. ...

Rosiglitazone: cardiac safety.(Safety and Efficacy Issues)(Clinical report)
June 22, 2007... Canada -- An article recently published in the New England Journal of Medicine (NEJM) has generated significant public attention on the cardiac safety of the antidiabetic rosiglitazone (Avandia[R], Avandamet[R] and Avandaryl[TM]).The article...

Rosiglitazone: cardiovascular safety profile.(Safety and Efficacy Issues)
June 22, 2007... Singapore -- Rosiglitazone (Avandia[R]) is an oral agent for the treatment of type 2 diabetes mellitus registered by the Health Sciences Agency (HSA) since 2000 for use as an adjunct to diet and exercise, as monotherapy, or in combination with...

Bevacizumab: tracheoesophageal fistula.(Safety and Efficacy Issues)
June 22, 2007... Canada -- Important new safety information regarding use of bevacizumab (Avastin[R]) has been released. Bevacizumab is a recombinant humanized monoclonal antibody that is directed against the vascular endothelial growth factor (VEGF). It is...

NSAIDS and cardiovascular risk.(Safety and Efficacy Issues)
June 22, 2007... Singapore -- Following worldwide voluntary withdrawal of rofecoxib (Vioxx[R]) in October 2004 due to concerns of an increased cardiovascular (CV) risk, HSA and its Expert Advisory Committee has reviewed the CV risks of the entire class of...

Rosiglitazone and parotid gland enlargement.(Safety and Efficacy Issues)
June 22, 2007... Canada -- The thiazolidinedione rosiglitazone (Avandia[R]) is an insulin sensitizer that is indicated for use either as monotherapy or in combination with metformin or a sulfonylurea in patients whose type 2 diabetes is inadequately controlled...

Cinacalcet: indication changes.(Safety and Efficacy Issues)
June 22, 2007... Canada -- The manufacturer of cinacalcet hydrochloride (Sensipar[R]) has announced that the product is no longer indicated for chronic kidney disease patients (stages 3 and 4) not receiving dialysis. Sensipar[R] was authorized by Health...

Omalizumab and anaphylaxis.(Safety and Efficacy Issues)
June 22, 2007... United States of America -- A New Medication Guide on the risk of anaphylaxis following administration of omalizumab (Xolair([R]) has been distributed. Omalizumab is approved to treat adults and adolescents (12 years of age and above) with...

Vinca alkaloids: intravenous administration.(Safety and Efficacy Issues)
June 22, 2007... France -- The French Agency for Safety of Medicines and Health Products (AFSSAPS) has reminded healthcare professionals that the chemotherapeutic agents vindesine, vincristine and vinblastine are to be given only by intravenous and not...

Pioglitazone: fractures in women.(Safety and Efficacy Issues)
June 22, 2007... Switzerland/Canada,/France -- The manufacturers of pioglitazone have informed health care professionals of the increased incidence of fractures in women receiving long-term treatment with pioglitazone for type 2 diabetes. Pioglitazone belongs...

Viracept[R]: suspension pending quality and safety assessment.(Regulatory Action and News)
June 22, 2007... European Union -- The European Commission has suspended the marketing authorization for Viracept[R] (INN-nelfinavir) (1). Nelfinavir is an antiretroviral medicine used to treat HIV-1 infected adults, adolescents and children of three years of...

Nimesulide: suspension following liver failure.(Regulatory Action and News)
June 22, 2007... Ireland -- The Irish Medicines Board (IMB) has announced suspension of nimesulide containing medicinal products for oral use with immediate effect (1). The suspended products include Aulin[R], Mesulid[R] and Mesine[R]. The decision was based on...

Tegaserod temporarily suspended.(Regulatory Action and News)(Brief article)
June 22, 2007... Singapore -- The Health Sciences Authority (HSA) has requested the manufacturer (Singapore) to temporarily withhold sales of tegaserod (Zelmac[R]) (1). This measure has been taken to permit further evaluation of new safety information submitted...

Withdrawal of products containing veralipride.(Regulatory Action and News)(Brief article)
June 22, 2007... European Union -- The European Medicines Agency (EMEA) has recommended the withdrawal of all medicinal products containing veralipride. EMEA made this recommendation following advice from the Committee for Medicinal Products for Human Use...

Global strategy to prevent transmission of Chagas disease.(Current Topics)
June 22, 2007... Chagas disease is a serious, potentially life-threatening illness caused by the protozoan parasite Trypanosoma cruzi. It is mainly transmitted by large blood-sucking insects. The parasite can also be transmitted by blood transfusion or organ...

Amodiaquine hydrochloride tablets.(International Pharmacopoeia)(Drug overview)
June 22, 2007... Draft proposal for the International Pharmocopoeia (June 2007). Please address any comments to Quality Assurance and Safety: Medicines, Medicines Policy and Standards, World Health Organization, 1211 Geneva 27, Switzerand. Fax +4122791 4730 or...

Chloroquine sulfate oral solution.(International Pharmacopoeia)
June 22, 2007... Draft proposal for the International Pharmocopoeia (June 2007). Please address any comments to Quality Assurance and Safety: Medicines, Medicines Policy and Standards, World Health Organization, 1211 Geneva 27, Switzerand. Fax +4122791 4730 or...

Paediatric artemether and lumefantrine oral suspension.(International Pharmacopoeia)
June 22, 2007... Draft proposal for the International Pharmocopoeia (June 2007). Please address any comments to Quality Assurance and Safety: Medicines, Medicines Policy and Standards, World Health Organization, 1211 Geneva 27, Switzerand. Fax +41 22 791 4730...

Sulfadoxine and pyrimethamine tablets.(International Pharmacopoeia)
June 22, 2007... Draft proposal for the International Pharmocopoeia (June 2007). Please address any comments to Quality Assurance and Safety: Medicines, Medicines Policy and Standards, World Health Organization, 1211 Geneva 27, Switzerand. Fax +41 22 791 4730...

Quinine sulfate tablets.(International Pharmacopoeia)
June 22, 2007... Draft proposal for the International Pharmocopoeia (June 2007). Please address any comments to Quality Assurance and Safety: Medicines, Medicines Policy and Standards, World Health Organization, 1211 Geneva 27, Switzerand. Fax +41 22 791 4730...

Rifampicin, isoniazid and ethambutol hydrochloride tablets.(International Pharmacopoeia)
June 22, 2007... Draft proposal for the International Pharmocopoeia (June 2007). Please address any comments to Quality Assurance and Safety: Medicines, Medicines Policy and Standards, World Health Organization, 1211 Geneva 27, Switzerand. Fax +41 22 791 4730...

Rifampicin and isoniazid dispersible tablets.(International Pharmacopoeia)
June 22, 2007... Draft proposal for the International Pharmocopoeia (June 2007). Please address any comments to Quality Assurance and Safety: Medicines, Medicines Policy and Standards, World Health Organization, 1211 Geneva 27, Switzerand. Fax +41 22 791 4730...

Rifampicin, isoniazid and pyrazinamide dispersible tablets.(International Pharmacopoeia)
June 22, 2007... Draft proposal for the International Pharmocopoeia (June 2007). Please address any comments to Quality Assurance and Safety: Medicines, Medicines Policy and Standards, World Health Organization, 1211 Geneva 27, Switzerand. Fax +41 22 791 4730...

Efavirenz capsules.(International Pharmacopoeia)
June 22, 2007... Draft proposal for the International Pharmocopoeia (May 2007). Please address any comments to Quality Assurance and Safety: Medicines, Medicines Policy and Standards, World Health Organization, 1211 Geneva 27, Switzerand. Fax +41 22 791 4730 or...

Nevirapine oral solution.(International Pharmocopoeia)(Drug overview)
June 22, 2007... Draft proposal for the International Pharmocopoeia (April 2007). Please address any comments to Quality Assurance and Safety: Medicines, Medicines Policy and Standards, World Health Organization, 1211 Geneva 27, Switzerand. Fax +41 22 791 4730...

Nevirapine tablets.(International Pharmacopoeia)(Drug overview)
June 22, 2007... Draft proposal for the International Pharmocopoeia (April 2007). Please address any comments to Quality Assurance and Safety: Medicines, Medicines Policy and Standards, World Health Organization, 1211 Geneva 27, Switzerand. Fax +41 22 791 4730...

Pharmacogenomics guidance from Health Canada.(Recent Publications, Information and Events)
June 22, 2007... Health Canada has released Submission of Pharmacogenomic Information, the final version of a regulatory guidance document issued following public consultation in 2006. It provides guidance to sponsors on how and when to submit pharmacogenomic...

Untangling the web: tenth edition.(Recent Publications, Information and Events)
June 22, 2007... Untangling the web of price reductions is a pricing guide for the purchase of antiretroviral medicines for developing countries, prepared by the Medecins Sans Frontieres Campaign for Access to Essential Medicines. The publication provides...

Priorities for dengue control.(Recent Publications, Information and Events)
June 22, 2007... Dengue is the most rapidly spreading vector borne disease. An estimated 50 million dengue infections occur annually and approximately 2.5 billion people live in dengue endemic countries. Because of the rapidly increasing public health...

PLoS Neglected Tropical Diseases open access journal.(Recent Publications, Information and Events)(Public Library of Science)(Brief article)
June 22, 2007... The Public Library of Science, PLoS, is announcing a new open-access online journal, PLoS Neglected Tropical Diseases at http://www.plosntds.org All PLoS articles are freely available online to use and share, and the copyright remains with...

International Nonproprietary Names for pharmaceutical Substances (INN).
June 22, 2007... RECOMMENDED International Nonproprietary Names: List 58 Notice is hereby given that, in accordance with paragraph 7 of the Procedure for the Selection of Recommended International Nonproprietary Names for Pharmaceutical Substances [Off....