WHO Drug Information articles from January 2008

WHO Drug Information archives from January 2008

Regulatory pathways for biosimilar products.(Challenges in Biotherapeutics)
January 1, 2008... Innovative biotherapeutic products such as insulin, human growth hormone and erythropoietin offer promise for treating many of the life threatening chronic diseases that present major challenges to public health programmes in both developed and...

WHO Programme for International Drug Monitoring: annual meeting.(Pharmacovigilance Focus)
January 1, 2008... The annual meeting of representatives from national centres participating in the WHO Programme for International Drug Monitoring was recently convened in Buenos Aires, Argentina. Working groups were set up during the meeting to discuss points...

Recall of heparin products extended.(Safety and Efficacy Issues)
January 1, 2008... United States of America -- On 11 February 2008, the Food and Drug Administration (FDA) informed healthcare professionals of important warnings and instructions for heparin sodium injection use. On 28 February 2008, the FDA issued an update to...

Contaminated heparin products recalled.(Safety and Efficacy Issues)
January 1, 2008... Canada -- Health Canada testing of heparin products marketed in Canada has identified a contaminant in products from manufacturer B. Braun Medical Inc. The contaminant, oversulphated condroitin sulphate, has also been found in heparin products...

Dacart[TM] development terminated and Lapdap-[TM] recalled.(Safety and Efficacy Issues)
January 1, 2008... Data from two Phase III clinical trials assessing use of the artemisinin-based combination therapy Dacart[TM], a fixed-dose combination of chlorproguanil, dapsone and artesunate, currently in clinical development have shown disappointing...

Varenicline and suicide attempts.(Safety and Efficacy Issues)
January 1, 2008... European Union -- The European Medicines Agency (EMEA) has concluded that updated warnings to doctors and patients are needed to increase awareness of cases of suicidal ideation and suicide attempts reported in patients using varenicline...

Norelgestromin-ethinyl estradiol: infarction & thromboembolism.(Safety and Efficacy Issues)
January 1, 2008... Canada -- Evra[R] is a transdermal hormonal contraceptive system containing 6 mg of norelgestromin and 0.6 mg of ethinyl estradiol per patch. Since its introduction on the Canadian market in early 2004, 16 cases of thromboembolism and 1 of...

Emerging cardiovascular concerns with rosiglitazone.(Safety and Efficacy Issues)
January 1, 2008... Australia -- The Australian Adverse Drug Reactions Advisory Committee (ADRAC) has drawn the attention of prescribers to an emerging concern about the cardiovascular safety of the thiazolidinedione (TZD) drug rosiglitazone. TZD drugs...

Disclosure of transdermal patches.(Safety and Efficacy Issues)
January 1, 2008... Australia -- The Therapeutic Goods Administration has received a report of an inadvertent overdose of opioid medicines caused when subcutaneous morphine was administered pre-operatively to a patient who was wearing a Norspan[R] transdermal...

Statement on safety of HPV vaccine.(Safety and Efficacy Issues)
January 1, 2008... European Union -- The European Medicines Agency (EMEA) has received reports of deaths in women who had previously received the HPV vaccine, Gardasil[R], including two reports concerning the sudden and unexpected deaths of two young women in the...

IVIG: myocardial infarction, stroke and thrombosis.(Safety and Efficacy Issues)
January 1, 2008... Canada -- Use of intravenous immune globulin (WIG) is reported to have increased by approximately 115% over the past 7-8 years, making Canada one of the highest per capita users of IVIG in the world (1). In this context of increasing use, it is...

Erythropoietins: lower haemoglobin levels.(Safety and Efficacy Issues)
January 1, 2008... Australia -- Dosage instructions for the use of erythropoiesis-stimulating agents (erythropoietins) in patients with chronic kidney disease have been updated in line with evidence that higher haemoglobin levels may be associated with an...

Erythropoiesis-stimulating agents.(Safety and Efficacy Issues)(Clinical report)
January 1, 2008... United States of America -- On 8 November 2007, the Food and Drug Administration (FDA) strengthened the warning sections for Epogen/Procrit[R] and Aranesp[R] following results of six studies showing decreased survival and/or tumour progression...

Pregabalin: hypersensitivity reactions.(Safety and Efficacy Issues)
January 1, 2008... Australia -- Pregabalin (Lyrica[R]) is approved for use in the treatment of neuropathic pain in adults and as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Post-marketing reports of...

Cefepime: increased mortality?(Safety and Efficacy Issues)
January 1, 2008... United States of America -- An article in a recent issue of The Lancet Infectious Diseases has raised the question about increased mortality with the use of cefepime. The Food and Drug Administration (FDA) is currently reviewing safety data and...

Mycophenolic acid: pregnancy loss and congenital malformation.(Safety and Efficacy Issues)
January 1, 2008... United States of America -- The manufacturer has informed prescribers that use of mycophenolic acid (MPA) (Myfortic[R]) during pregnancy is associated with increased risks of pregnancy loss and congenital malformations. This new important...

Carbamazepine and skin reactions.(Safety and Efficacy Issues)
January 1, 2008... United States of America -- The Food and Drug Administration (FDA) has informed patients that dangerous or even fatal skin reactions (Stevens Johnson syndrome and toxic epidermal necrolysis), that can be caused by carbamazepine therapy, are...

Canada Vigilance: a new name and database.(Safety and Efficacy Issues)(Report)
January 1, 2008... Health Canada is pleased to announce Canada Vigilance as the new name for the Canadian Adverse Drug Reaction Monitoring Program. The Program is also implementing a new database that will provide an enhanced capacity for the postmarketing...

Desmopressin and hyponatraemia.(Safety and Efficacy Issues)
January 1, 2008... United States of America -- The Food and Drug Administration (FDA) has requested that prescribing information for desmopressin includes important new information about severe hyponatraemia and seizures. Certain patients taking desmopressin...

Influenza virus vaccine: northern hemisphere winter.(Regulatory Action and News)
January 1, 2008... World Health Organzation -- It is recommended that vaccines for use in the 2008-2009 influenza season (northern hemisphere winter) contain the following: * an A/Brisbane/59/2007 (H1N1)-like virus. * an A/Brisbane/10/2007 (H3N2)-like...

Lumiracoxib-containing medicines: withdrawal.(Regulatory Action and News)(Brief article)
January 1, 2008... European Union -- The European Medicines Agency (EMEA) has recommended withdrawal of the marketing authorizations for all lumiracoxib-containing medicines, because of the risk of serious side effects affecting the liver. Lumiracoxib is a...

Thalidomide approved for multiple myeloma.(Regulatory Action and News)
January 1, 2008... European Union -- The European Medicines Agency (EMEA) has recommended the approval of thalidomide (Thalidomide Pharmion[R]) for the treatment of multiple myeloma, a rare cancer of the bone marrow. The Committee for Medicinal Products for...

New genetic test for breast cancer.(Regulatory Action and News)
January 1, 2008... United States of America -- The Food and Drug Administration has approved a test that helps in assessing the risk of tumour recurrence and long-term survival for patients with relatively high-risk breast cancer. The TOP2A FISH pharmDx[R] is the...

Natalizumab for moderate-to-severe Crohn disease.(Regulatory Action and News)
January 1, 2008... United States of America -- The Food and Drug Administration has approved natalizumab (Tysabri[R]), currently approved for use in treating some forms of multiple sclerosis, for the treatment of moderate-to-severe Crohn disease in patients with...

First test to detect and identify 12 respiratory viruses.(Regulatory Action and News)
January 1, 2008... United States of America -- The Food and Drug Administration has approved a test that simultaneously detects and identifies 12 specific respiratory viruses. The test, called the xTAG Respiratory Viral Panel[R], is the first test for the...

Miglustat: withdrawal by manufacturer.(Regulatory Action and News)(Brief article)
January 1, 2008... European Union -- The European Medicines Agency (EMEA) has been formally notified of the decision to withdraw an application for an extension of indication for the centrally authorized medicine miglustat (Zavesca[R]). Miglustat was...

Voluntary withdrawal of clobutinol cough syrup.(Regulatory Action and News)
January 1, 2008... Singapore -- Clobutinol (Silomat[R]) was licenced in Singapore in 1999. It is an orally active non-opioid antitussive agent, and is indicated for the treatment of irritable, non-productive cough and inflammatory disorders of the airways. ...

Proposed harmonized requirements: licensing vaccines in the Americas.(Current Topics)
January 1, 2008... A Vaccines Working Group of the Pan-American Network on Drug Regulatory Harmonization (PANDRH) was established in March 2005 to develop harmonized documents and approaches to the licensing of vaccines in the Americas. At its first meeting,...

Sixteen types of counterfeit artesunate circulating in South-east Asia.(Current Topics)(Survey)(Brief article)
January 1, 2008... In the late 1990s counterfeits of artesunate, a vital life-saving antimalarial drug, were discovered circulating in South-east Asia. Surveys have suggested that 38%-53% of shop-bought artesunate in mainland South-east Asia are fake and have...

Eastern Mediterranean Ministers tackle high medicines prices.(Current Topics)
January 1, 2008... Medicines prices, availability, affordability and other component issues were recently discussed by delegates at a meeting of the Regional Committee for WHO's Eastern Mediterranean Region, held in Cairo 20-23 October 2007. Results were...

ATC/DDD classification (temporary).(ATC/DDD Classification)
January 1, 2008... ATC/DDD Classification (temporary) The following anatomical therapeutic chemical (ATC) classifications and Defined daily doses (DDDs) were agreed by the WHO International Working Group for Drug Statistics Methodology in 24-25 October 2007....

ATC/DDD classification (final).(ATC/DDD Classification)
January 1, 2008... ATC/DDD Classification (final) The following anatomical therapeutic chemical (AI G) classifications and defined daily doses (DDDs) were agreed by the WHO International Working Group for Drug Statistics Methodology in March 2007. They...

Cycloserinum cycloserine.(Consultation Document: The International Pharmacopoeia)(Drug overview)
January 1, 2008... Draft proposal for the International Pharmocopoeia (November 2007). Please address any comments to Quality Assurance and Safety: Medicines, PSM, World Health Organization, 1211 Geneva 27, Switzerland. Fax +4122 791 4730 or e-mail to...

Cycloserini capsulae cycloserine capsules.(Consultation Document: The International Pharmacopoeia)(Drug overview)
January 1, 2008... Draft proposal for the International Pharmocopoeia (November 2007). Please address any comments to Quality Assurance and Safety: Medicines, PSM, World Health Organization, 1211 Geneva 27, Switzerland. Fax +4122 791 4730 or e-mail to...

Assessing the quality of herbal medicines: contaminants and residues.(Recent Publications, Information and Events)
January 1, 2008... This WHO guideline Assessing the quality of herbal medicines." with reference to contaminants and residues presents a general overview of potentially hazardous contaminants and residues in herbal medicines and includes guiding principles for...

Launch of procurement and supply management website.(Recent Publications, Information and Events)
January 1, 2008... The AIDS Medicines and Diagnostic Service (AMDS) of WHO and its partner organizations have initiated development of a unique procurement and supply management website for HIV-related health commodities: the PSM Toolbox. The PSM Toolbox...

Malaria research collection published.(Recent Publications, Information and Events)
January 1, 2008... Leading research scientists, physicians, and public health specialists from around the world have published papers on new insight into the international burden of malaria and how the global community can best combat the disease. The...

New pricing bulletin.(Recent Publications, Information and Events)
January 1, 2008... Since publishing the WHO/HAl survey tool in mid-2003, over 50 surveys have been conducted worldwide measuring medicine prices, availability, affordability, and price components in the supply chain from manufacturer to patient. More surveys are...

How to improve the use of medicines by consumers.(Recent Publications, Information and Events)
January 1, 2008... A revised version of the WHO guide How to improve the use of medicines by consumers is now available on the WHO Medicines website. Influencing human behaviour is a complex undertaking that requires careful groundwork and carries...

Model quality assurance system for procurement agencies.(Recent Publications, Information and Events)
January 1, 2008... The Model quality assurance system for procurement agencies was developed by WHO through an extensive consultative process. The final guide was endorsed by the WHO Expert Committee on Specifications for Pharmaceutical Preparations in 2005 and...

Training courses in management and supply.(Recent Publications, Information and Events)
January 1, 2008... Managing drug supply in developing countries Managing drug supply in developing countries is a training course covering the complete drug management cycle. The course is run by IDA solutions and WHO and is designed to expose participants to...

Pharmacists work to improve use of generics.(Recent Publications, Information and Events)
January 1, 2008... Pharmacists in Singapore have linked up with the Consumer Association, CASE, to educate and empower patients on generic products, and advocate generics as a cost-saving solution. Joint initiatives have included public forums and publication of...

International Nonproprietary Names for Pharmaceutical Substances (INN).
January 1, 2008... RECOMMENDED International Nonproprietary Names: List 59 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....

Amendments to previous lists modifications Apportees aux listes anterieures modificaciones a las listas anteriores.
January 1, 2008... Recommended International Nonproprietary Names (Rec. INN): List 49 Denominations communes internationales recommandees (DCI Rec.): Liste 49 Denominaciones Comunes Internacionales Recomendadas (DCI Rec.): Lista 49 (WHO Drug...