WHO Pharmaceuticals Newsletter No. 2, 2016

OMS, 19 de abril de 2016

Contenido

Asuntos Regulatorios

Carbamazepine .................................................................................. 5
Cisplatin ............................................................................................ 5
Entecavir hydrate .............................................................................. 5
Eribulin mesylate ............................................................................... 6
Esomeprazole magnesium hydrate .................................................... 6
Flunitrazepam .................................................................................... 6
Furosemide......................................................................................... 7
Fusafungine nose and mouth sprays .................................................. 7
Idelalisib ........................................................................................... .7
Imatinib mesylate .............................................................................. .8
Inhaled corticosteroids for chronic obstructive pulmonary disease ... 8
Loxoprofen ........................................................................................ .8
Methylphenidate hydrochloride ...........................................................9
Mirabegron ...........................................................................................9
Mycophenolate mofetil ........................................................................9
Opioid pain medicines ........................................................................ 10
Natalizumab .................................................................................... ..10
Piperacillin and tazobactam combination ............................................11
Piperacillin containing products (alone or in combination with tazobactam)  11
Risperidone and paliperidone ............................................................. 12
Simeprevir........................................................................................... 12
Sodium-glucose co-transporter-2 (SGLT2) inhibitors ....................... 12
Verteporfin ......................................................................................... 13

Seguridad de medicamentos
Bcr-Abl tyrosine kinase inhibitors........................................................ 14
Levonorgestrel-releasing intrauterine systems .................................. 14
Nicorandil ............................................................................................ 14
Pseudoephedrine containing over-the-counter products .................... 15
Rivaroxaban ......................................................................................... 15
Spironolactone and renin-angiotensin system drugs ........................... 15
Ticagrelor ............................................................................................ 16
Trametinib .............................................................................................16
Valproate ............................................................................................. 17
Vit.D3® (colecalciferol) ........................................................................17

Señales
Levetiracetam and impaired renal function .......................................... .18
Benznidazole and severe skin reactions ................................................24

Feature
Seasonal Malaria Chemoprevention and Pharmacovigilance,
Rabat, Morocco, February 2016 ..........................................................26


disponible en línea en http://bit.ly/1U8AZ2V

WHO Pharmaceuticals Newsletter No. 1, 2016

OMS, 16 de febrero de 2016

Regulatory Matters

Amlodipine besilate............................................................................... 5

Antiretroviral medicines ...................................................................... ..5

Atovaquone ........................................................................................... 5

Azilsartan .............................................................................................. 6

Benzoyl peroxide and salicylic acid topical products ............................... 6

Bisphosphonates .................................................................................... 6

Deferasirox ............................................................................................ 7

Elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate and

anti-epileptic medications ........................................................................ 7

Fluoroquinolones oral antibiotics ............................................................. 7

Fomepizole ............................................................................................. 8

Fingolimod............................................................................................... 8

Interferon beta-1a ................................................................................... 8

Itraconazole ............................................................................................. 9

Lenvatinib ................................................................................................ 9

Levonorgestrel intrauterine contraceptive device (IUCD) ........................... 9

Mycophenolate mofetil ............................................................................ 10

Nintedanib ethanesulfonate ...................................................................... 10

Nivolumab .............................................................................................. 10

Ombitasvir hydrate/paritaprevir hydrate/ritonavir ...................................... 10

Peginterferon alfa-2a ............................................................................... 11

Piperacillin sodium ...................................................................................11

Posaconazole ..........................................................................................11

Repaglinide and clopidogrel .....................................................................12

Sodium glucose co-transporter 2 (SGLT2) inhibitors ................................12

Thalidomide ........................................................................................... 12

Varenicline and alcohol............................................................................ 13

Safety of Medicines

Allopurinol ..............................................................................................14

Bevacizumab ..........................................................................................14

Codeine........................................................................................... ..... 14

Finasteride ..............................................................................................15

Melatonin ............................................................................................. 15

Pazopanib ....................................................................................... ..... 15

Proton pump inhibitors ................................................................... .... 16

Rosiglitazone .................................................................................. ..... 16

Signal

Vemurafenib and Atrial fibrillation: Signal strengthening ..................... .....17

Feature

Recommendations from the 38th Annual Meeting of Representatives of

the National Pharmacovigilance Centres participating in the WHO

Programme for International Drug Monitoring .................................. ..... 24

Número completo disponible en http://bit.ly/1ot1ynd

WHO Pharmaceuticals Newsletter No. 5, 2015

OMS, 22 de octubre de 2015

Tabla de contenidos

Regulatory Matters

• Amantadine hydrochloride
• Asunaprevir and daclatasvir
• Azithromycin hydrate
• Canagliflozin
• Clozapine
• Deferasirox
• Fingolimod
• Hydroxyzine-containing medicines
• Infliximab
• Ingenol mebutate gel
• Laninamivir octanoate and zanamivir
• Memantine hydrochloride
• Nivolumab
• Panitumumab
• Pomalidomide
• Proton pump inhibitors
• Risperidone
• Sodium-glucose co-transporter 2 (SGLT2) inhibitors
• Sterile talc
• Treanda® Injection

Safety of medicines

• Bortezomib
• Brintellix® (vortioxetine) and Brilinta® (ticagrelor)
• DPP-4 Inhibitors for Type 2 Diabetes
• Eltrombopag
• Etanercept
• Gadolinium-based Contrast Agents for Magnetic Resonance Imaging (MRI)
• Pseudoephedrine and ephedrine
• Rivaroxaban
• Tramadol oral drops

Signal

• Dextromethorphan and serious neurological disorders in children
• Olanzapine and accidental drug intake by children
• Temozolomide and Oesophagitis

Feature

• WHO-UMC-HSA Inter-Regional Pharmacovigilance Training, Singapore, 30 September -2 October
• 2015
• The World Health Organization organizes an integrated vigilance workshop for Eastern Mediterranean regional countries in Rabat
• Building Pharmacovigilance in Member States of Central African Economic Monetary Community (CEMAC)

Disponible en http://bit.ly/1RYJ2M2

WHO Pharmaceuticals Newsletter No. 4, 2015

OMS, 1 de septiembre de 2015

Contenidos

Regulatory Matters

Abiraterone acetate ............................................................................ 5

Adefovir pivoxil ....................................................................................5

Anagliptin ............................................................................................ 5

Asunaprevir and daclatasvir hydrochloride ..........................................5

Crizotinib ........................................................................................... ..6

Denosumab ......................................................................................... 6

Dimethyl fumarate................................................................................6

Ethinylestradiol /etonogestrel vaginal ring .......................................... 7

Ferumoxytol ........................................................................................ 7

Fusidic acid and HMG-CoA reductase inhibitors .................................. 7

Ibuprofen ............................................................................................. 8

Indapamide ........................................................................................... 8

Influenza HA vaccine .......................................................................... ..8

Interferon beta-1a ................................................................................ 9

Ivabradine ............................................................................................. 9

Methotrexate ....................................................................................... 10

Methylphenidate transdermal system ................................................. 10

Methylprednisolone (intravenous injection) ......................................... 10

Non-aspirin Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) ............ 11

Pregabalin .............................................................................................11

Sorafenib .............................................................................................. 12

Technetium (99mTc) hydroxymethylenediphosphonate injection ......... 12

Tramadol hydrochloride ..................................................................... ...12

Ustekinumab ..........................................................................................13

Ziprasidone ............................................................................................13

Safety of medicines

Codeine Cough-and-Cold Medicines in Children .............................15

Combined hormonal birth control products ....................................15

Denosumab ..................................................................................... 15

Diazoxide ........................................................................................ 16

Febuxostat ...................................................................................... 16

Ibuprofen in high dose (≥2400mg/day).......................................... 16

Influenza vaccine ............................................................................. 17

Latanoprost eye drop ...................................................................... 17

Melatonin ......................................................................................... 18

Sodium glucose co-transporter 2 (SGLT2) inhibitors (canagliflozin,

dapagliflozin, empagliflozin) ..... 18

Zoledronic acid infusion ..................................................................... 18

Signal

Atomoxetine and Dystonia in paediatric patients .................................. 20

Vemurafenib and Tumour lysis syndrome ............................................ 25

Feature

Summary of Recommendations from the Twelfth Meeting of the WHO

Advisory Committee on Safety of Medicinal Products (ACSoMP) .............. 30

Implementing Patient Reporting of Adverse Reactions in Ghana ............. 32

disponible en http://bit.ly/1KphTCr