Vient de paraître :
The Who Pharmaceuticals letter, n°1, 2006
préparé pavec le Centre collaborateur OMS pour l'évaluation des médicaments à Upsala, Suède
http://www.who.int/medicines/publications/newsletter/PN2006_1.pdf
TABLE OF CONTENTS Regulatory Matters
Alefacept -- Contraindicated in HIV patients............................................................................1
Beta-2 adrenoceptor agonists -- Label to warn of risk of asthma...........................................1
Clozapine -- Blood monitoring requirements tightened..........................................................1
Coagulation Factor VII a (Recombinant) -- Thromboembolic events added to label...................2
(Kaizen) Ephedrine Hydrochloride tablet -- Not authorized as a weight-loss product.................2
Epoetin products -- Labels to warn of severe anaemia and pure red cell aplasia............................2
Estradiol/testosterone injection -- Discontinued due to safety reasons...................................2
Ketamine -- Classified as Class C drug..................................................................................3
Nevirapine -- SPC to include new hepatotoxic warnings.........................................................3
Rh0(D) Immune Globulin -- Intravascular haemolysis events added to label..............................3
Telithromycin -- Reports of liver toxicity................................................................................3
Safety of Medicines
Baclofen -- Adverse reactions due to device related issues......................................................5
Clarithromycin -- Study reports fatal cardiac events...........................................................5
Colchicine -- Dosage decreased for better safety................................................................5
Corticosteroids (Topical) -- Reports of facial damage........................................................5
Gatifloxacin -- Serious effects on blood glucose levels..........................................................5
Glucosamine -- Reports of allergic skin reactions...............................................................6
Immune Globulin Intravenous -- Reports of haemolytic reactions.........................................6
Leflunomide -- Reports of pneumonitis.......................................................................................6
Letrozole -- Contraindicated in premenopausal women: a reminder...........................................7
Oseltamivir -- Interaction with warfarin..................................................................................7
Proton pump inhibitors -- Reports of gynaecomastia.........................................................7
Quetiapine -- Urinary disorders.....................................................................................................7
Rosiglitazone -- Reports of macular oedema....................................................................8
Shortclean -- Found to contain glibenclamide...........................................................................8
Statins -- Reports of amnesia.........................................................................................................8
Technetium (99m Tc) fanolesomab -- Suspended due to safety concerns................................9
Warfarin -- Interaction with grapefruit seed extract.............................................................9
Warfarin -- Serious skin reactions reported............................................................................9
Feature
Recommendations from the third meeting of the WHO Advisory Committee on Safety of Medicinal Products................................................................................................................................................................................10