WHO Drug Information articles from January 2007

WHO Drug Information archives from January 2007

International Conference on Harmonization (ICH).(Quality Assurance)(Brief article)
January 1, 2007... The harmonization of regulatory requirements between Europe, Japan and the USA began to materialize as a result of discussions held in conjunction with the International Conference of Drug Regulatory Authorities (ICDRA) of the World Health...

New developments in quality.(Quality Assurance)
January 1, 2007... The ICH Steering Committee (SC) and its Expert Working Groups (EWGs) met in Chicago, Illinois from 21 to 26 October 2006. WHO has observer status in ICH and participated in the discussions of the SC and various EWGs with the objective of...

Rotavirus vaccine and intussusception.(Safety and Efficacy Issues)
January 1, 2007... United States of America--The Food and Drug Administration (FDA) has notified health care providers about 28 post-marketing reports of intussusception following administration of rotavirus live oral pentavalent vaccine (RotaTeq[R]), indicated...

Zolpidem and bizarre sleep related effects.(Safety and Efficacy Issues)
January 1, 2007... Australia--Zolpidem (Stilnox[R]) was marketed in Australia in late 2000 for the short term treatment of insomnia. It is structurally unrelated to the benzodiazepines, but has a similar pharmacological action. In 2002, the Australian Adverse...

Rituximab: life-threatening brain infection.(Safety and Efficacy Issues)
January 1, 2007... United States of America--The Food and Drug Administration (FDA) has received reports of death in two patients treated with rituximab (Rituxan[R]) for systemic lupus erythematosus (SLE). Both patients developed progressive multifocal...

Methadone for pain: cardiac and respiratory changes.(Safety and Efficacy Issues)
January 1, 2007... United States of America -- The Food and Drug Administration (FDA) has received reports of death and life-threatening side effects in patients taking methadone (Dolophine[R]). These have occurred in patients newly starting methadone for pain...

Levofloxacin: dysglycemia and liver disorder.(Safety and Efficacy Issues)
January 1, 2007... Canada -- Levofloxacin, marketed in Canada since 1997, is a broad-spectrum fluoroquinolone antibiotic that is indicated for the treatment of certain respiratory tract, skin and urinary tract bacterial infections in adults (1). Dysglycemia (2-4)...

Domperidone: heart rate and rhythm disorders.(Safety and Efficacy Issues)
January 1, 2007... Domperidone is a peripheral dopamine antagonist structurally related to the butyrophenones with antiemetic and gastroprokinetic properties (1). In Canada, domperidone (Motilium[R]) was marketed in 1985 but has not been available since 2002....

Complications with use of bone cement.(Safety and Efficacy Issues)
January 1, 2007... Canada -- Reports have been received relating to serious complications, including death, associated with the use of bone cement in vertebroplasty and kyphoplasty procedures. Vertebroplasty and kyphoplasty are relatively new procedures that...

Infant deaths associated with cough and cold medications.(Safety and Efficacy Issues)
January 1, 2007... United States of America -- Cough and cold medications that contain nasal decongestants, antihistamines, cough suppressants, and expectorants commonly are used alone or in combination in attempts to temporarily relieve symptoms of upper...

Ranibizumab and stroke.(Safety and Efficacy Issues)
January 1, 2007... United States of America -- The manufacturer of ranibizumab injection (Lucentis[R]) has advised healthcare professionals of new safety information. In an ongoing study (SAILOR) of ranibizumab delivered intravitreally to patients with...

Increased risk of fractures: antiepileptic medicines.(Safety and Efficacy Issues)
January 1, 2007... Australia -- Reduced bone mineral density and subsequent increased risk of fractures is documented in patients taking enzyme-inducing antiepileptic medicines such as phenytoin, phenobarbitone, and primidone long-term (1). The risk is higher in...

Vasovist[R] and nephrogenic systemic fibrosis.(Safety and Efficacy Issues)(Brief article)
January 1, 2007... European Union -- The Pharmacovigilance Working Party (PhVWP) has discussed the issue of nephrogenic systemic fibrosis (NSF) associated with gadolinium-containing contrast agents for magnetic resonance imaging (MRI). Nephrogenic systemic...

The challenges of ensuring pain medication.(Access to Medicines)
January 1, 2007... On page 18 of this issue of WHO Drug Information, Dr Jack Jagwe describes how action by Hospice Africa Uganda (HAU) has made a dramatic difference to the lives of people in his country suffering from pain. WHO estimates that annually over...

Import and safe distribution of oral morphine for pain relief in Uganda.(Access to Medicines)
January 1, 2007... Early beginnings of palliative care With support from friends in the United Kingdom, Dr Anne Merriman introduced palliative care to Uganda in 1993 based on methods of dealing with severe pain originally devised at St. Christopher's Hospice,...

Developments in biological quality, safety and efficacy.(Topics of Current Interest)
January 1, 2007... Biological medical products such as vaccines, blood products, biotherapeutics and associated diagnostics save lives, reduce suffering and improve health, but only if products and technologies are of good quality, safe, effective, available,...

Transparency in medicines management.(Topics of Current Interest)
January 1, 2007... The value of the global pharmaceutical market is estimated to be over US$ 500 billion, making the pharmaceutical sector highly vulnerable to corruption and unethical practices. Transparency International estimates that, on average, 10 to 25% of...

WHO Programme on Good Governance for Medicines.(Topics of Current Interest)
January 1, 2007... In response to the current situation, and guided by its Medicines Strategy (1), WHO has initiated the Good Governance for Medicines Programme. Established in late 2004, the Programme's overall goal is to curb corruption in medicines procurement...

Use of concordance to improve patient adherence.(Rational Use of Medicine)
January 1, 2007... Poor adherence to long-term therapies severely compromises the effectiveness of treatment, making this a critical issue in public health both from the perspective of improved quality of life and health economics. Increasing the effectiveness of...

Influencing health professionals for better health outcomes.(Rational Use of Medicine)
January 1, 2007... Effectiveness of drug therapy depends to a great extent on patient adherence to prescribed medication. However, there is abundant evidence [1] that patient adherence may sometimes average no more than 50% in long-term treatment. Non-compliance...

ATC/DDD classification (temporary).(ATC/DDD Classification)(anatomical therapeutic chemical )
January 1, 2007... The following anatomical therapeutic chemical (ATC) classifications and defined daily doses (DDDs) were agreed by the WHO International Working Group for Drug Statistics Methodology 30-31 October 2006. Comments or objections to the decisions...

ATC/DDD classification (final).(ATC/DDD Classification)
January 1, 2007... 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 March 2006. They came into force on 1 October 2006 and will...

Draft proposal for The International Pharmacopoeia (December 2006).(International Pharmacopoeia)
January 1, 2007... [ILLUSTRATION OMITTED] Relative molecular mass. 410.4 Chemical name. (3R,4R,SS)-4-Acetylamino-5-amino-3-(1-ethylpropoxy)-1 -cyclohexene-1-carboxylic acid, ethyl ester, phosphate (1:1) Description. A white to off-white powder. ...

Draft proposal for The International Pharmacopoeia (October 2006).(International Pharmacopoeia)
January 1, 2007... Lumefantrinum Lumefantrine [ILLUSTRATION OMITTED] [C.sub.30][H.sub.32.][Cl.sub.3]NO Relative molecular mass. 528.9 Chemical name. 2-Dibutylamino-1-[2, 7-dichloro-9-(4-chlorobenzylidene)-9H-fluoren-4-yl]-ethanol (racemate);...

Dissolution tests.(The International Pharmacopoeia)
January 1, 2007... Work has been carried out on developing dissolution tests for addition to certain tablet monographs of The International Pharmacopoeia in accordance with the approach and priorities agreed by the WHO Expert Committee on Specifications for...

International Pharmacopoeia: fourth edition.(Recent Publications, Information and Events)(Book review)
January 1, 2007... This new edition consolidates the texts of the five separate volumes of the third edition. In preparing this consolidated edition, a review has been undertaken of the general notices with additions and amendments to clarify interpretation and...

Draft report: specifications for pharmaceutical preparations.(Recent Publications, Information and Events)(Brief article)
January 1, 2007... The advice and recommendations provided by this Expert Committee on Specifications for Pharmaceutical Preparations are intended to serve national and regional authorities and, in particular, drug regulatory authorities, procurement agencies,...

User guide for micro, small and medium sized enterprises.(Recent Publications, Information and Events)
January 1, 2007... A user guide has been published by the European Medicines Agency for micro, small and medium sized enterprises (SMEs) on the administrative and procedural aspects of the provisions laid down in Regulation (EC) No 726/2004, that are of...

International Nonproprietary Names for pharmaceutical substances (INN).
January 1, 2007... RECOMMENDED International Nonproprietary Names: List 57 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....