WHO Drug Information articles from March 2008

WHO Drug Information archives from March 2008

WHO prequalification: progress in 2007.(Access to Medicines)
March 22, 2008... The Prequalification Programme for medicinal products is a service provided by the World Health Organization (WHO) to facilitate access to medicines that meet international unified standards of quality, safety and efficacy for HIV/AIDS,...

Update on safety of heparin.(Safety and Efficacy Issues)
March 22, 2008... World Health Organization--On 17 January 2008, Baxter Healthcare Corporation began voluntary recall of nine lots of heparin sodium in the USA. The adverse events are described as acute allergic-type reactions and have been documented by the...

Nicorandil-associated ulceration.(Safety and Efficacy Issues)(Excerpt)
March 22, 2008... Australia -- Nicorandil (Ikorel[R]) is a synthetic nicotine derivative, which causes arterial and venous dilatation. It is indicated for the treatment of chronic stable angina pectoris at a dose of 10-20 mg daily. Nicorandil-associated...

Topiramate and other drugs causing glaucoma.(Safety and Efficacy Issues)
March 22, 2008... Australia -- Topiramate is an antiepileptic indicated for either monotherapy or add-on therapy in adults and in children aged two years and over; and for the prophylaxis of migraine in adults. It has an authority required Pharmaceutical...

Varenicline: serious psychiatric reactions.(Safety and Efficacy Issues)(Excerpt)
March 22, 2008... Canada -- Varenicline tartrate (Champix[R]) has been marketed in Canada since April 2007 and is indicated for smoking-cessation treatment in adults in conjunction with smoking-cessation counselling (1). The efficacy of varenicline in smoking...

Montelukast: safety review.(Safety and Efficacy Issues)
March 22, 2008... United States of America -- The Food and Drug Administration (FDA) is investigating a possible association between the use of montelukast (Singulair[R]) and behavior/mood changes, suicidality and suicide. Montelukast is a leukotriene receptor...

Neurocognitive effects of chemotherapy.(Safety and Efficacy Issues)
March 22, 2008... Australia -- There is growing evidence that some patients who survive cancer can suffer neurocognitive impairment after chemotherapy. Although the symptoms are generally subtle and improve after ceasing chemotherapy, for some survivors...

New MMRV vaccine recommendations.(Safety and Efficacy Issues)
March 22, 2008... United States of America -- On 27 February 2008, new information was presented to the Advisory Committee on Immunization Practices (ACIP) regarding the risk for febrile seizures among children aged 12--23 months after administration of the...

Oseltamivir label updated with neuropsychiatric warning.(Safety and Efficacy Issues)
March 22, 2008... United States of America -- The product label for oseltamivir phosphate (Tamiflu[R]) has been revised to include a warning about possible neuropsychiatric events. The updated label is based on recommendations from the agency's Pediatric...

Ketoconazole tablets: risk of hepatotoxicity.(Safety and Efficacy Issues)
March 22, 2008... United Kingdom--Following a systematic review of all available data, the manufacturer of ketoconazole (Nizoral[R]) tablets has released information on a change to the Summary of Product Characteristics (SmPC) because of a risk of serious...

Alemtuzumab: infection-related deaths.(Safety and Efficacy Issues)
March 22, 2008... United Kingdom -- Bayer Schering Pharma AG and Genzyme Europe BV have informed physicians of six infection-related deaths, reported from a trial (CALGB10101) in which previously untreated, symptomatic B-cell chronic lymphocytic leukemia (CLL)...

Mycophenolate mofetil: progressive multifocal leukoencephalopathy.(Safety and Efficacy Issues)
March 22, 2008... European Union -- In agreement with the European Medicines Agency (EMEA), the manufacturer of mycophenolate mofetil (CellCept[R]) has advised physicians of new safety information. CellCept[R] has been on the market for over 10 years, as an...

Modafinil: serious rash and psychiatric symptoms.(Safety and Efficacy Issues)
March 22, 2008... United Kingdom -- The manufacturer of modafinil (Provigil[R]) has informed physicians of new warnings and safety information regarding: * Serious skin rash and psychiatric symptoms. The safety concern involves serious skin rashes...

Moxifloxacin: serious hepatic and skin reactions.(Safety and Efficacy Issues)
March 22, 2008... United Kingdom/European Union -- In agreement with EU regulatory authorities, including the Medicines and Healthcare Products Regulatory Agency (MHRA), the manufacturer of moxifloxacin (Avelox[R]) has released important safety information. A...

Rimonabant: depression; psychiatric reactions.(Safety and Efficacy Issues)
March 22, 2008... United Kingdom -- Rimonabant (Acomplia[R]) is contraindicated in patients with ongoing major depression or those taking antidepressants. Prescribers are encouraged to take a detailed history from patients before prescribing. However,...

Exenatide: risk of acute pancreatitis.(Safety and Efficacy Issues)
March 22, 2008... United Kingdom -- Exenatide (Byetta[R]), the first-in-class incretin mimetic, is a glucagon-like-peptide-1 analogue that stimulates insulin release from pancreatic cells in a glucose dependent manner. Exenatide is indicated for treatment of...

Zanamivir: neuropsychiatric events.(Safety and Efficacy Issues)
March 22, 2008... United Kingdom -- The manufacturer of zanamivir (Relenza[R]) Inhalation Powder has updated the package insert as a result of postmarketing reports (mostly from Japan) of delirium and abnormal behaviour leading to injury in patients with...

Inosine ponophosphate dehydrogenase inhibitors: congenital anomalies.(Safety and Efficacy Issues)
March 22, 2008... United States of America -- The Food and Drug Administration (FDA) is aware of reports of infants born with serious congenital anomalies, including microtia and cleft lip and palate, following exposure to mycophenolate mofetil (MMF) during...

Strontium ranelate: life-threatening allergic reactions.(Safety and Efficacy Issues)
March 22, 2008... Singapore -- Strontium ranelate (Protos[R], Servier) has been registered since July 2006 for the treatment of postmenopausal osteoporosis to reduce the risk of vertebral and hip fractures. Since its launch in Europe in 2004, Protos[R] has...

Lapatinib and hepatoxicity.(Safety and Efficacy Issues)
March 22, 2008... Singapore -- In consultation with HSA, the manufacturer of lapatinib (Tykerb[R]) has informed healthcare professionals of new safety information on hepatotoxicity. From the manufacturer's worldwide safety database, 39 cases of...

Telbivudine and peripheral neuropathy.(Safety and Efficacy Issues)
March 22, 2008... Singapore -- Telbivudine (Sebivo[R]) is indicated for the treatment of HBeAg-positive and HBeAg-negative chronic hepatitis B in patients who have compensated liver disease, evidence of viral replication and active liver inflammation, and who...

International Nonproprietary Names for monoclonal antibodies: IFPMA proposal.(International Nonproprietary Names)
March 22, 2008... This summary represents the IFPMA proposal presented to the 46th Consultation on International Nonproprietary Names (INNs) for Pharmaceutical Substances held at the World Health Organization in Geneva in April 2008. The proposal was developed...

Dydrogesterone withdrawn for commercial reasons.(Regulatory Action and News)(Brief article)
March 22, 2008... United Kingdom -- Dydrogesterone (Duphaston[R]) is to be withdrawn from the market from March 2008 for commercial reasons. Dydrogesterone was licensed for use in several indications, including threatened or recurrent miscarriage,...

Withdrawal of lumiracoxib.(Regulatory Action and News)(Excerpt)
March 22, 2008... Australia -- Lumiracoxib is a selective COX-2 inhibitor, which was registered in Australia in 2004 for the symptomatic relief of osteoarthritis (at 200 mg daily) and for the treatment of acute pain and pain due to primary dysmenorrhoea (400...

Enoxaparin contamination: batches recalled.(Regulatory Action and News)
March 22, 2008... Australia -- The Therapeutic Goods Administration (TGA) has recalled five batches of the anticoagulant medicine enoxaparin (Clexane[R]) due to the detection of an impurity in the affected batches. The TGA has required testing of all...

Recombinant antihemophilic factor approved.(Regulatory Action and News)
March 22, 2008... United States of America -- The Food and Drug Administration (FDA) has licensed a treatment for hemophilia A, a rare, hereditary blood-clotting disorder that affects approximately 15 000 individuals, almost exclusively males, in the United...

Esomeprazole magnesium approved for children.(Regulatory Action and News)
March 22, 2008... United States of America -- The Food and Drug Administration (FDA) has approved esomeprazole magnesium (Nexium[R]) for short-term use in children 1-11 years of age for the treatment of gastroesophageal reflux disease (GERD). The agency...

Rotavirus vaccine approved.(Regulatory Action and News)
March 22, 2008... United States of America -- The Food and Drug Administration (FDA) has announced the approval of Rotarix[R], the second oral US licensed vaccine for the prevention of rotavirus, an infection that causes gastroenteritis (vomiting and diarrhea)...

New version of genetically engineered Factor VIIa approved.(Regulatory Action and News)
March 22, 2008... United States of America -- The Food and Drug Administration (FDA) has approved a new formulation of the genetically engineered version of Factor VIIa, a plasma protein essential for the clotting of blood. The new formulation allows the...

Role of The International Pharmacopoeia in quality assurance.(International Pharmacopoeia)
March 22, 2008... In the pharmaceutical sense, a pharmacopoeia is an official, legally binding publication containing recommended quality specifications for the analysis and determination of drug substances, specific dosage forms, excipients and finished drug...

International nonproprietary names for pharmaceutical substances (INN)/Denominations communes internationales des substances pharmaceutiques (DCI)/Denominaciones Comunes Internacionales para las Sustancias Farmaceuticas (DCI).
March 22, 2008... Notice is hereby given that, in accordance with article 3 of the Procedure for the Selection of Recommended International Nonproprietary Names for Pharmaceutical Substances, the names given in the list on the following pages are under...

Amendments to previous lists/Modifications apportees aux listes anterieures/Modificaciones a las listas anteriores.
March 22, 2008... AMENDMENTS TO PREVIOUS LISTS MODIFICATIONS APPORTEES AUX LISTES ANTERIEURES MODIFICACIONES A LAS LISTAS ANTERIORES Proposed International Non Proprietary Names (Prop. INN): List 95 Denominations communes internationales proposees...