NEW DRUGS UNDER INTENSIVE SURVEILLANCE ..NOVEMBER 2004

[Guest guest]

NOVEMBER 2004

NEW DRUGS UNDER INTENSIVE SURVEILLANCE

REPORT ANY ADVERSE REACTION WHICH COULD CONCEIVABLY BE ASSOCIATED

WITH:

COMMITTEE ON SAFETY

OF MEDICINES

New additions this month: Advate (Octocog alfa), Inspra (Eplernone),

Physeptone (Methadone injection), Protelos (Strontium ranelate),

Raptiva

(Efalizumab), Synastone (Methadone injection)

Removals this month: Dovobet (Calcipotriol/Betamethasone)

Trade Name/s (Generic Name) Trade Name/s (Generic Name) Trade Name/s

(Generic Name)

Abilify (Aripiprazole) & #56256; & #56407;

Actonel Once-Weekly (Risedronate Sodium) & #56256; & #56407;

Actos (Pioglitazone) & #56256; & #56407;

Advate (Octocog alfa) & #56256; & #56407;

Almogran (Almotriptan) & #56256; & #56407;

Androgel (Testosterone gel) & #56256; & #56407;

Anzemet (Dolasetron) & #56256; & #56407;

Aranesp (darbepoetin alfa) & #56256; & #56407;

Arava (Leflunomide) & #56256; & #56407;

Arcoxia (Etoricoxib) & #56256; & #56407;

Arixtra (Fondaparinux) & #56256; & #56407;

Asmanex Twisthaler (Mometasone Furoate) & #56256; & #56407;

Atrovent CFC-free (Ipratropium bromide) & #56256; & #56407;

Avandamet (Rosiglitazone/Metformin) & #56256; & #56407;

Avandia (Rosiglitazone) & #56256; & #56407;

Avelox (Moxifloxacin) & #56256; & #56407;

Avodart (Dutasteride) & #56256; & #56407;

BCG Vaccine SSI (BCG) & #56256; & #56407;

Bextra (Valdecoxib) & #56256; & #56407;

Bondronat (Ibandronic acid) & #56256; & #56407;

Busilvex (Busulfan) & #56256; & #56407;

Carbaglu (Carglumic acid) & #56256; & #56407;

Cardicor (Bisoprolol) & #56256; & #56407;

Cellcept (Mycophenolate mofetil) & #56256; & #56407;

Celluvisc (Carmellose) & #56256; & #56407;

Ceprotin (Human Protein C) & #56256; & #56407;

Cerazette (Desogestrel) & #56256; & #56407;

Chirocaine (Levobupivacaine) & #56256; & #56407;

Cialis (Tadalafil) & #56256; & #56407;

Cipralex (Escitalopram) & #56256; & #56407;

Co-diovan (Valsartan &

Hydrochlorothiazide) & #56256; & #56407;

Concerta XL (Methylphenidate

Hydrochloride) & #56256; & #56407;

Copaxone (Glatiramer acetate) & #56256; & #56407;

Copegus (Ribavirin) & #56256; & #56407;

Cosmofer (Iron Dextran Complex) & #56256; & #56407;

Creon 40 000 (Pancreatin) & #56256; & #56407;

Crestor (Rosuvastatin) & #56256; & #56407;

Dovobet (Calcipotriol/Betamethasone) & #56256; & #56407;

Dukoral (Cholera vaccine) & #56256; & #56407;

Dynastat (Parecoxib) & #56256; & #56407;

Ebixa (Memantine) & #56256; & #56407;

Elidel (Pimecrolimus) & #56256; & #56407;

Emtriva (Emtricitabine) & #56256; & #56407;

Enbrel (Etanercept) & #56256; & #56407;

Erbitux (cetuximab) & #56256; & #56407;

Eucardic (Carvedilol) & #56256; & #56407;

Evra (Norelgestromin-ethinylestradiol) & #56256; & #56407;

Ezetrol (Ezetimibe) & #56256; & #56407;

Faslodex (Fulvestrant) & #56256; & #56407;

Fasturtec (Rasburicase) & #56256; & #56407;

Flolan 1.5mg (Epoprostenol) & #56256; & #56407;

Fludara – oral (Fludarabine) & #56256; & #56407;

Forsteo (Teriparatide) & #56256; & #56407;

Foscan (Temoporfin) & #56256; & #56407;

Fuzeon (Enfuvirtide) & #56256; & #56407;

Gadovist (Gadobutrol) & #56256; & #56407;

Glivec (Imatinib) & #56256; & #56407;

Hepsera (Adefovir dipivoxil) & #56256; & #56407;

Herceptin (Trastuzumab) & #56256; & #56407;

Hipfix (Human blood coagulation factor IX) & #56256; & #56407;

Humira (Adalimumab) & #56256; & #56407;

Infanrix (Diphtheria Tetanus & Pertussis) & #56256; & #56407;

Infanrix-HIB ( Diphtheria Tetanus pertussis

& Haemophilus Influenza & #56256; & #56407;

Inspra (Eplernone) & #56256; & #56407;

Insuman Basal (Human insulin) & #56256; & #56407;

Insuman Comb (Human insulin) & #56256; & #56407;

Insuman Rapid (Human insulin) & #56256; & #56407;

Isovorin (Levofolinic Acid) & #56256; & #56407;

Invanz (Ertapenem) & #56256; & #56407;

Keppra (Levetiracetam) & #56256; & #56407;

Ketek (Telithromycin) & #56256; & #56407;

Kineret (Anakinra) & #56256; & #56407;

Lantus (Insulin glargine) & #56256; & #56407;

Levemir (Insulin determir) & #56256; & #56407;

Levitra (Vardenafil) & #56256; & #56407;

Losec IV (Omeprazole) & #56256; & #56407;

Lumigan (Bimatoprost) & #56256; & #56407;

Lyrica (Pregabalin) & #56256; & #56407;

Mabcampath (Alemtuzumab) & #56256; & #56407;

Malarone (Atovaquone & Proguanil) & #56256; & #56407;

Metvix (Methylaminolevulinate Hcl) & #56256; & #56407;

Miacalcic Nasal Spray(Calcitonin (salmon)) & #56256; & #56407;

MicardisPlus (Telmisartan &

Hydrochlorothiazide) & #56256; & #56407;

Migard (Frovatriptan) & #56256; & #56407;

Myfortic (mycophenolic acid) & #56256; & #56407;

Myocet (Doxorubicin) & #56256; & #56407;

Neoclarityn (Desloratadine) & #56256; & #56407;

Neulasta (Pegfilgrastim) & #56256; & #56407;

Nexium IV (Esomeprazole) & #56256; & #56407;

Normosang (Hemin) & #56256; & #56407;

NovoMix 30 (Insulin Aspart Biphasic) & #56256; & #56407;

Novonorm (Repaglinide) & #56256; & #56407;

NovoRapid (Insulin Aspart) & #56256; & #56407;

Octegra (Moxifloxacin) & #56256; & #56407;

Okacyn (Lomefloxacin) & #56256; & #56407;

Olmetec (Olmesartan medoximil) & #56256; & #56407;

Opatanol (Olopatadine), & #56256; & #56407;

Oxynorm injection (Oxycodone) & #56256; & #56407;

Ovitrelle (Choriogonadotropin alfa) & #56256; & #56407;

Pediacel (Tetanus, diphtheria, acellular

pertussis, inactivated polio, haemophilus

influenza type

& #56256; & #56407;

Pegasys (Peginterferon alpha-2a) & #56256; & #56407;

PegIntron (PegInterferon alfa-2b) & #56256; & #56407;

Perfalgan (Paracetamol) & #56256; & #56407;

Photofrin (Porfimer Sodium) & #56256; & #56407;

Physeptone (Methadone injection) & #56256; & #56407;

Pletal (Cilostazol) & #56256; & #56407;

Prevenar (Pneumococcal saccharide) & #56256; & #56407;

Propecia (Finasteride) & #56256; & #56407;

Protelos (Strontium ranelate) & #56256; & #56407;

Protopic (Tacrolimus) & #56256; & #56407;

Provigil (Modafinil) & #56256; & #56407;

Rapamune (Sirolimus) & #56256; & #56407;

Raptiva (Efalizumab) & #56256; & #56407;

Rebetol (Ribavirin) & #56256; & #56407;

Relestat (Epinastine) & #56256; & #56407;

Relpax (Eletriptan bromide) & #56256; & #56407;

Remicade (Infliximab) & #56256; & #56407;

Repevax (Tetanus, diphtheria, acellular

pertussis, inactivated polio, haemophilus

influenza type

& #56256; & #56407;

Revaxis (Tetanus, diphtheria, acellular

pertussis, inactivated polio, haemophilus

influenza type

& #56256; & #56407;

Reyataz (Atazanavir) & #56256; & #56407;

Riamet (Artemether & Lumefantrine) & #56256; & #56407;

Risperdal Consta (Risperidone) & #56256; & #56407;

Silkis (Calcitriol) & #56256; & #56407;

Somavert (Pegvisomant) & #56256; & #56407;

Sonovue (Sulphur hexafluoride) & #56256; & #56407;

Spiriva (Tiotropium bromide monohydrate) & #56256; & #56407;

Stalevo (Levodopa/Carbidopa/Entacapone) & #56256; & #56407;

Strattera (Atomoxetine hydrochloride) & #56256; & #56407;

Sustiva (Efavirenz) & #56256; & #56407;

Synagis (Palivizumab) & #56256; & #56407;

Synastone (Methadone injection) & #56256; & #56407;

Tamiflu (Oseltamivir) & #56256; & #56407;

Targretin (Bexarotene) & #56256; & #56407;

Telzir (Fosamprenavir) & #56256; & #56407;

Testogel (Testosterone gel) & #56256; & #56407;

Tisseel Kit (Fibrinogen) & #56256; & #56407;

Tracleer (Bosentan) & #56256; & #56407;

Tramacept (Tramadol/Paracetamol) & #56256; & #56407;

Transtec (Buprenorphine) & #56256; & #56407;

Travatan (Travaprost) & #56256; & #56407;

Triapin (Felodipine & Ramipril) & #56256; & #56407;

Trileptal (Oxcarbazepine) & #56256; & #56407;

Trisenox (Arsenic trioxide) & #56256; & #56407;

Uftoral(Tegafur/Uracil) & #56256; & #56407;

Valcyte (Valganciclovir Hcl) & #56256; & #56407;

Varilrix (Varicella virus OKA strain) & #56256; & #56407;

Varivax (Varicella virus OKA strain) & #56256; & #56407;

Velcade (Bortezomib) & #56256; & #56407;

Vaniqa (Eflornithine) & #56256; & #56407;

Ventavis (Iloprost) & #56256; & #56407;

Vesicare (Solifenacin succinate) & #56256; & #56407;

Viadur (Leuprorelin) & #56256; & #56407;

ViraferonPeg (PegInterferon alfa-2b) & #56256; & #56407;

Viramune (Nevirapine) & #56256; & #56407;

Viread (Tenofovir diproxil) & #56256; & #56407;

Virgan Eye Gel (Ganciclovir) & #56256; & #56407;

Xalacom (Latanoprost & Timolol) & #56256; & #56407;

Xeloda (Capecitabine) & #56256; & #56407;

Xigris (Drotrecogin alfa [activated]) & #56256; & #56407;

Xyzal (Levocetirizine) & #56256; & #56407;

Yasmin (Drosperinone/ethinylestradiol) & #56256; & #56407;

Yentreve (Duloxetine) & #56256; & #56407;

Ytracis (Yttrium chloride) & #56256; & #56407;

Zaditen Eye Drops (Ketotifen) & #56256; & #56407;

Zavesca (Miglustat) & #56256; & #56407;

Zenapax (Daclizumab) & #56256; & #56407;

Zevalin (Ibritumomab tiuexetan) & #56256; & #56407;

Zibor (Bemiparin sodium) & #56256; & #56407;

Zomig Nasal Spray (Zolmitriptan) & #56256; & #56407;

Zyban (Bupropion) & #56256; & #56407;

Zyvox (Linezolid)

How to report:

Yellow cards can be found in:

& #56256; & #56464; The BNF & #56256; & #56464; ABPI Data Sheet Compendium

& #56256; & #56464; FP10 prescription pads & #56256; & #56464; The OTC Directory

or by calling the National Yellow Card Information Service on 0800

731 6789

or online at www.yellowcard.gov.uk

Where to send your report:

CSM Freepost London SW8 5BR

or if you are in one of the following NHS Regions:

CSM West Midlands Freepost Birmingham B18 7BR CSM Wales Freepost

Cardiff CF4 1ZZ

CSM Northern Freepost 1085 Newcastle-upon-Tyne NE1 1BR CSM Mersey

Freepost Liverpool L3 3AB