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Contents ‰ Encourage the Integration of Pharmacovigilance for Regulatory Matters ‰ Antiretrovirals in Some Sub-Saharan African Countries

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Contents ‰ Encourage the Integration of Pharmacovigilance for Regulatory Matters ‰ Antiretrovirals in Some Sub-Saharan African Countries No. 3, 2004 EDITORIAL In addition to the usual updates on recent drug safety and regulatory information for medicines, this issue of the newsletter features an article summarizing the decisions regarding the use of Selective Serotonin Reuptake Inhibitor (SSRI) -antidepressants in children. Most of these products appear to have a negative benefit-risk balance when used in treating major depressive disorder (MDD) in children. HIV/AIDS was one of the key health issues that figured in the discussions of the recently concluded Fifty-seventh World Health Assembly (WHA) in Geneva. Through Resolution WHA57.14 on HIV/AIDS (http://www.who.int/gb), the WHA requested the Director-General to strengthen the WHO prequalification project managed by the World Health Organization (WHO) for pharmaceutical and diagnostic products to diagnose, treat and manage HIV/AIDS and urged Member States to make best use of WHO's list of prequalified antiretroviral drugs that meet international quality standards (see http://mednet3.who.int/prequal for key facts on the WHO prequalification project). With the global focus on treating HIV, and consistent with WHO's 3 by 5 initiative to provide treatment to three million HIV patients by the year 2005, it is timely that a training course will be held in September 2004 in South Africa to Contents encourage the integration of pharmacovigilance for Regulatory matters antiretrovirals in some sub-Saharan African countries. Details of this course as well as the complete course material will be Safety of medicines made available on the website of the Department of Essential Feature Drugs and Medicines Policy (EDM) http://www.who.int/ medicines at a later date, after the course. TABLE OF CONTENTS REGULATORY MATTERS ARIPIPRAZOLE, CLOZAPINE, QUETIAPINE AND OTHER ATYPICAL ANTIPSYCHOTICS -- Label to indicate risk of hyperglycaemia and diabetes... 1 MUROMONAB-CD3 -- Serious adverse reactions in paediatric patients....................................... 1 NU BAO -- Presence of animal derivatives and human tissue poses health risks.......................... 1 OTC DRUGS -- New labelling rules to increase safety .............................................................. 2 SHITEK TONGKAT ALI PLUS 400MG -- Presence of tadalafil ..................................................... 2 TOLCAPONE -- Marketing re-authorized, but more stringent monitoring recommended ............... 2 TRAZODONE -- Interactions with CYP3A4 inhibitors/inducers ................................................... 2 SAFETY OF MEDICINES CARVEDILOL -- Reports of diarrhoea..................................................................................... 4 CYCLO-OXYGENASE-2 INHIBITORS -- Reports of visual disturbances ........................................ 4 FURANOCOUMARINS -- Presence in a herbal preparation......................................................... 4 LEFLUNOMIDE -- Awareness and monitoring can reduce the impact of adverse effects ................ 5 OXANDROLONE -- Warning for interaction with warfarin.......................................................... 5 SHUBAO SLIMMING CAPSULES -- Presence of fenfluramine and nitrosofenfluramine................... 5 STATINS -- Important to measure creatine kinase levels ......................................................... 6 TEGASEROD -- Warning about diarrhoea and ischaemic colitis ................................................. 6 THIOMERSAL IN VACCINES -- Recent evidence supports safety................................................ 6 ZAFIRLUKAST -- Reports of serious hepatic events ................................................................. 7 FEATURE ..................................................................................................................... 8 REGULATORY MATTERS ARIPIPRAZOLE, psychotic agent quetiapine notably cerebral oedema and fumarate (Seroquel), had herniation; nine cases of CLOZAPINE, warned health professionals cerebral oedema have been QUETIAPINE that patients should be reported worldwide since monitored for glucose control 1986, with six deaths due to AND OTHER before starting treatment cerebral herniation. Paediatric ATYPICAL ANTI- with atypical antipsychotics. patients treated with PSYCHOTICS More recently, in April 2004, muromonab-CD3 may also be the company has issued an at increased risk of Label to indicate risk of additional letter that besides lymphoproliferative and hyperglycaemia and pre-treatment monitoring, infectious complications diabetes patients should also be compared to adults. A large monitored periodically for proportion of children may USA. The United States Food worsening of glucose control not have been infected by and Drug Administration throughout treatment. pathogens such as herpes (US FDA) has requested that viruses prior to trans- Bristol-Myers Squibb Com- References: plantation and are therefore pany, the manufacturer of the 1. 'Dear Healthcare Practitioner' letter from Bristol-Myers Squibb more susceptible to atypical antipsychotic drug Company, 25 March 2004. developing primary infections aripiprazole (Abilify) should Available from URL: from the grafted organ update the prescribing www.fda.gov/medwatch following immuno- information for the drug to 2. 'Dear Healthcare Provider' letter suppression with muro- reflect the risk of from Novartis, 01 April 2004. Available from URL: monab-CD3. Janssen-Ortho hyperglycaemia and diabetes http://www.fda.gov/medwatch Inc. is currently working with in patients treated with this 3. 'Dear Healthcare Provider' letter Health Canada to update the drug. More recently, Novartis, from AstraZeneca Canadian Product Monograph under advice from the US Pharmaceuticals LP, 22 April to include the above FDA has also made similar 2004. Available from URL: http://www.fda.gov/medwatch information. changes to the prescribing information for clozapine Reference: (Clozaril) antipsychotic MUROMONAB- Letter to Hospital Chief of Medical Staff, from Janssen-Ortho Inc., 13 tablets. The US FDA has CD3 May 2004. Available from URL: recommended these revisions http://www.hc-sc.gc.ca after reviewing data related Serious adverse reactions in paediatric to the use of atypical NU BAO antipsychotics and hyper- patients Presence of animal glycaemia with its related Canada. Janssen-Ortho Inc., symptoms ( e.g., polydipsia, under advice from Health derivatives and human polyuria, polyphagia and Canada is warning health tissue poses health weakness). The FDA has professionals that muro- risks concluded that all atypical monab-CD3 (ORTHOCLONE antipsychotics should be UK. The patient information OKT*3) is not approved for leaflet for a traditional updated to include infor- paediatric use (age up to 17 mation about the potential for Chinese medicine named Nu years) in Canada. Bao lists human placenta, these adverse events. Muromonab-CD3 is a murine Patients with risk factors for deer antler (Corna cervi monoclonal antibody oantotrichum) and donkey diabetes should undergo indicated for the treatment of baseline screening before skin (Colla cori astini) as the acute renal, cardiac, and ingredients present in the treatment with any atypical hepatic allograft rejection antipsychotic drug and capsules of the product. refractory to conventional Although the information on routine monitoring should anti-rejection therapy or be undertaken throughout the source of these when conventional therapy is ingredients is limited, the therapy to mitigate the risk of contraindicated in adult patients developing serious Medicines and Healthcare patients. Paediatric patients Products Regulatory Agency metabolic complications. In treated with this product may January 2004 AstraZeneca (MHRA) advices that all be at an increased risk of animal and human tissue Pharmaceuticals LP, manu- developing serious neuro- facturer of atypical anti- derivatives carry a potential logical complications, most risk of infectious diseases due WHO Pharmaceuticals Newsletter No. 3, 2004 • 1 REGULATORY MATTERS to the transmission of SHITEK indicated in the treatment of infective bacteria and viruses. Parkinson's disease. The The MHRA is therefore TONGKAT ALI marketing authorization for advising that consumers PLUS 400MG tolcapone was suspended in should not take this product. Europe in November 1998 Presence of tadalafil Current users should stop following concerns about taking the product and should Malaysia. The Drug Control hepatotoxicity and neurol- consult their doctor if they Authority of Malaysia has eptic malignant syndrome feel unwell. The MHRA has detected the presence of associated with the use of written to suppliers to cease tadalafil in a traditional this drug. However, based on marketing Nu Bao with medicine sold under the its recent safety evaluation, immediate effect. name of Shitek Tongkat Ali the committee has stated Reference: Plus 400mg in Malaysia. The that the drug may be re- Herbal Safety News, May 2004. product had a fraudulent introduced into the European Available from URL: marketing authorization market under stringent http://medicines.mhra.gov.uk number printed on its monitoring for liver function package and was manufac- effects. The committee also OTC DRUGS tured by a contract recommends that the drug should be contraindicated in New labelling rules to manufacturer, Shitek Micro Algae Sdn Bhd. Tadalafil is a patients with certain medical increase safety prescription drug and could histories, including liver USA. New US FDA labelling pose serious health hazards if disease and neuroleptic rules for over-the-counter used without
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