WHO Drug Information articles from June 2008

WHO Drug Information archives from June 2008

ICH Pharmaceutical Quality System Q10.(International Harmonization)(International Conference on Harmonization)
June 22, 2008... The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline Pharmaceutical Quality System Q10 was adopted at the ICH meeting in Portland (Oregon, USA) in June 2008....

African Medicines Regulatory Harmonization Initiative (AMRHI): a WHO concept paper.(International Harmonization)
June 22, 2008... Essential medicines save lives and improve health when they are available, affordable, of assured quality and properly used. However, lack of access to essential medicines remains one of the most serious global public health problems (1)....

Moxifloxacin: adverse hepatic reactions.(Safety and Efficacy Issues)
June 22, 2008... European Union -- Finalizing a review of the safety of moxifloxacin-containing medicines for oral use, the European Medicines Agency (EMEA) has concluded that these medicines should only be prescribed in the treatment of acute bacterial...

Ezetimibe/simvastatin: safety review of cancer risk.(Safety and Efficacy Issues)
June 22, 2008... United States of America -- The Food and Drug Administration (FDA) is investigating a report from the SEAS trial (Simvastatin and Ezetimibe in Aortic Stenosis) of a possible association between the use of Vytorin[R] (a combination of...

Norfloxacin-containing medicines not for use in urinary infections.(Safety and Efficacy Issues)
June 22, 2008... European Union -- The European Medicines Agency (EMEA) has recommended restricting the use of oral norfloxacin-containing medicines in urinary infections. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the...

Ceftriaxone: fatal outcome with calcium-containing solutions.(Safety and Efficacy Issues)
June 22, 2008... Canada -- There is a risk of precipitation when ceftriaxone and calcium are administered concurrently via intravenous route. Cases of fatal reactions with ceftriaxone-calcium precipitates in lung and kidneys have been described in neonates and...

Safety review of tumour necrosis factor blockers.(Safety and Efficacy Issues)
June 22, 2008... United States of America -- The Food and Drug Administration (FDA) is investigating the possible association between use of tumor necrosis factor (TNF) blockers (marketed as Remicade[R], Enbrel[R], Humira[R], and Cimzia[R]) and the development...

Recombinant human bone morphogenetic protein: life-threatening complications.(Safety and Efficacy Issues)
June 22, 2008... United States of America -- The Food and Drug Administration (FDA) has received reports of life-threatening complications associated with recombinant human bone morphogenetic protein (rhBMP) when used in the cervical spine. It is of note that...

Electronic medical devices malfunction: computed tomography scanning.(Safety and Efficacy Issues)
June 22, 2008... United States of America -- The Food and Drug Administration (FDA) is alerting users to the possibility that x-rays used during computed tomography (CT) examinations may cause some implanted and external electronic medical devices to...

Desmopressin and hyponatraemia.(Safety and Efficacy Issues)
June 22, 2008... Australia -- Desmopressin (Minirin[R], Octostim[R]) is a synthetic analogue of the natural ant/diuretic hormone (ADH) arginine vasopressin and is currently available in nasal spray, nasal solution, tablet, sublingual wafer, and injection form....

Micro-bubble contrast agents.(Safety and Efficacy Issues)(Brief article)
June 22, 2008... United States of America -- The Food and Drug Administration (FDA) has issued an alert to healthcare professionals about changes that were made to the prescribing information for micro-bubble contrast agents. The revised boxed warning and...

Simvastatin used with amiodarone: rhabdomyolysis.(Safety and Efficacy Issues)
June 22, 2008... United States of America -- The Food and Drug Administration (FDA) has issued an alert to healthcare professionals about the risk of a rare condition of muscle injury called rhabdomyolysis, which can lead to kidney failure or death, when...

Naltrexone injection site reactions.(Safety and Efficacy Issues)
June 22, 2008... United States of America -- The Food and Drug Administration (FDA) has issued an alert to healthcare professionals about the risk of adverse injection site reactions in patients receiving naltrexone (Vivitrol[R]). Physicians should instruct...

Adalimumab: hepatosplenic T-cell lymphoma.(Safety and Efficacy Issues)
June 22, 2008... United Kingdom -- The manufacturer of adalimumab (Humira[R]) is advising healthcare professionals of new safety information. Adalimumab is a TNF alpha blocker authorized in adult patients for the treatment of rheumatoid arthritis, psoriatic...

Serious risks/new safety information.(Safety and Efficacy Issues)
June 22, 2008... United States of America -- The Food and Drug Administration (FDA) has published a table listing the names of products and potential signals of serious risks/new safety information that were identified for these products during the period...

Deferasirox: hepatic failure.(Safety and Efficacy Issues)
June 22, 2008... United Kingdom -- In agreement with European Union regulatory authorities, the manufacturer of deferasirox (Exjade[R]) has advised healthcare professionals of updated safety information. Deferasirox is indicated for the treatment of chronic...

Abacavir: hypersensitivity reactions.(Safety and Efficacy Issues)
June 22, 2008... United States of America -- The Food and Drug Administration (FDA) has issued an alert to healthcare professionals about serious and sometimes fatal hypersensitivity reactions (HSR) caused by abacavir therapy which are significantly more common...

Fluoroquinolones: risk of tendinitis and tendon rupture.(Safety and Efficacy Issues)
June 22, 2008... United States of America -- The Food and Drug Administration (FDA) has notified manufacturers that a boxed warning is necessary in the labelling for fluoroquinolones concerning the increased risk of tendinitis and tendon rupture. The agency...

Colchicine: fatal interactions and reactions.(Safety and Efficacy Issues)
June 22, 2008... Australia -- Colchicine is indicated for the treatment of acute gout, but it has a narrow therapeutic index with significant potential for toxicity and severe drug interactions. In mid-2007, the Therapeutic Goods Administration (TGA) required...

WHO prequalification: GMP deviations and suspension.(Regulatory Action and News)(good manufacturing practices)
June 22, 2008... World Health Organization -- WHO's Medicines Prequalification Programme has issued a Notice of Concern letter to Sandoz South Africa Ltd. based on the results of inspections performed at their manufacturing facility in Kempton Park, South...

Import alert: Ranbaxy facilities.(Regulatory Action and News)
June 22, 2008... United States of America -- The US Food and Drug Administration (FDA) has issued two Warning Letters to Ranbaxy Laboratories Ltd and simultaneously established an Import Alert for drugs manufactured or using materials from two Ranbaxy...

Medicines Prequalification Programme: listed products.(Regulatory Action and News)
June 22, 2008... World Health Organization -- The WHO Medicines Prequalification Programme, in close cooperation with national regulatory agencies and partner organizations, was established to make quality priority medicines available for the benefit of those...

Development of medicines for Alzheimer disease and Parkinson disease.(Regulatory Action and News)
June 22, 2008... European Union -- The European Medicines Agency (EMEA) has released two guidelines for companies developing medicines for the treatment of Alzheimer disease and other dementias and for Parkinson disease, in light of recent scientific progress...

GMP regulations for radiopharmaceuticals.(Regulatory Action and News)
June 22, 2008... European Union -- Revised good manufacturing practice (GMP) requirements for the production of radiopharmaceuticals have been published by the European Commission (EC). The updates to the annex are intended to make it compliant with GMP...

WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce.(Pharmaceutical Distribution and Trade)
June 22, 2008... Quality assurance of pharmaceutical products should be based on a reliable system of marketing authorization, independent analysis of finished product quality and confirmation through independent inspection that all manufacturing operations are...

Proposal for improvement of the WHO Certification Scheme.(Pharmaceutical Distribution and Trade)
June 22, 2008... In 1969, WHO developed a guideline entitled Good practice in the manufacture and quality control of drugs. The good manufacturing practices (GMP) guideline together with the first version of the Certification Scheme on the quality of...

Consultation on improvement of the Certification Scheme.(Pharmaceutical Distribution and Trade)
June 22, 2008... The Forty-second Expert Committee on Specifications for Pharmaceutical Preparations discussed and identified a number of perceived problems with the operation of the WHO Certification Scheme on the quality of pharmaceutical products moving in...