Description

Review: Reboxetine (Edronax) Following an MHRA re-evaluation of the risks and benefits of reboxetine (Edronax), this drug has had its designation changed from RED-RED to AMBER

New Formulation Assessment: Exenatide prolonged release injection (Bydureon) approved for use as an alternative to twice daily exenatide (Byetta) where the twice daily product is poorly tolerated

Rapid Drug Assessment: Modified release sodium valproate granules (Epilim Chronospheres) Licensed for all forms of epilepsy designated GREEN

Drug Safety Update: Citalopram associated with dose dependent QT interval prolongation

Drug Safety Update: European Medicines Agency guidance recommends restricting the role of dronedarone (Multaq)

New East Midlands guidance on the use of LABA/ICS combination inhalers in chronic obstructive pulmonary disease

NICE TA230: Bivalirudin for the treatment of ST-segment-elevation myocardial infarction (July 2011)

New Trials in Brief: Increasing use of insulin analogues across the NHS

Updated advice on supply problems with insulin glulisine (Apidra)

Description

New Indication Assessment: Dabigatran etexilate (Pradaxa) for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and is designated RED-RED

NICE CG26: Management of stable angina (July 2011)

Review: Ivabradine 5mg and 7.5mg tablets (Procoralan) and Ranolazine 375mg, 500mg and 750mg tablets (Ranexa) re-assessed and are now designated AMBER

NICE TA228: Bortezomib and thalidomide for the first-line treatment of multiple myeloma (July 2011)

NICE TA229: Dexamethasone intravitreal implant for the treatment of macular oedema secondary to retinal vein occlusion (July 2011)

NICE TA233: Golimumab for the treatment of ankylosing spondylitis (August 2011)

NICE TA234: Abatacept for the treatment of rheumatoid arthritis after the failure of conventional disease-modifying anti-rheumatic drugs (August 2011)

MHRA Drug Safety Updates (August and September 2011): Withdrawal of Onsenal (Celecoxib); Systemic fusidic acid and interaction with statins - risk of rhabdomyolysis; Antipsychotic use during third trimester of pregnancy

Description

SUPPLY PROBLEMS WITH INSULIN GLULISINE (APIDRA) update on the current supply problems affecting insulin glulisine (Apidra) and on the planned discontinuation of Opticlik, Opticlik Pro 1 and Optiset insulin pen devices

Description

New Drug Assessment: Ketamine oral solution (50mg in 5ml) and Ketamine injection for palliative care designated AMBER

Rapid Drug Assessment:

Bilastine 20mg tablets (Ilaxten) Licensed for the symptomatic treatment of allergic rhino-conjunctivitis and urticaria. Designated RED-RED

Linezolid 600mg tablets and 100mg in 5ml oral suspension (Zyvox) Licensed for the treatment of community acquired pneumonia, nosocomial pneumonia, skin infections and soft tissue infections when the causative organism is known to be a Gram-positive bacteria. Designated RED

NICE TA224: Golimumab for the treatment of methotrexate-naive rheumatoid arthritis (terminated appraisal) (June 2011)

NICE TA225: Golimumab for the treatment of rheumatoid arthritis after the failure of previous disease-modifying anti-rheumatic drugs (June 2011)

NICE TA226: Rituximab for the first-line maintenance treatment of follicular non-Hodgkin’s lymphoma (June 2011)

NICE TA227: Erlotinib monotherapy for maintenance treatment of non-small-cell lung cancer (June 2011)

New Trials in Brief: Is a more prominent role for Leukotriene Receptor Antagonists justified in the treatment of asthma? Tiotropium – more on cardiovascular risks of Spiriva Respimat; Non-Steroidal Anti-Inflammatory Drugs and Atrial Fibrillation or Flutter

MHRA Drug Safety Update (July 2011): Thalidomide – Risk of arterial and venous thromboembolism; Paracetamol – Updated dosing schedule for children; Addiction to benzodiazepines and codeine

MHRA Drug Safety Update (August 2011): Pioglitazone and bladder cancer

Description

Pioglitazone and bladder cancer

New Formulation Assessment: Vardenafil orodispersible tablets (Levitra)

Rapid Drug Assessment:

Tobramycin 3mg/ml eye drops (Tobravisc) Superficial bacterial eye infections designated RED-RED

Adapalene and benzoyl peroxide gel 0.1%/2.5% (Epiduo) Treatment of acne vulgaris with comedones, papules and pustules designated GREEN

NICE Technology Appraisal 223: Cilostazol, naftidrofuryl oxalate, pentoxifylline and inositol nicotinate for the treatment of intermittent claudication in people with peripheral arterial disease (May 2011)

News in Brief: New guideline on atopic eczema, Are all beta blockers the same in heart failure? Updated meningococcal guidance.

MHRA Drug Safety Update (June 2010): Bisphosphonates: atypical femoral fractures; Yasmin: risk of venous thromboembolism

European Medicines Agency safety review of dronedarone (Multaq)

Description

New Patent Expiries: Anastrozole and Risedronate

NICE TA217: Donepezil, galantamine, and memantine for the treatment of Alzheimer’s disease (March 2011)

NICE TA219: Everolimus for the second-line treatment of advance renal cell carcinoma (April 2011)

NICE TA220 Golimumab for the treatment of psoriatic arthritis (April 2011)

NICE TA221: Romiplostim for the treatment of chronic immune (idiopathic) thrombocytopenic purpura (April 2011)

NICE TA222: Trabectedin for the treatment of relapsed ovarian cancer (April 2011)

New Trials in Brief: Higher Doses of Levothyroxine and Fracture Risk; Angiotensin Receptor Blockers and Cardiovascular Risk

News in Brief: New advice on drug interactions and hormonal contraception; PPIs – too much of a good thing; Gabapentin for neuropathic pain; Dopamine agonists for restless legs syndrome

MHRA Drug Safety Update (May 2010): Prasugrel - rare but serious hypersensitivity reactions

Description

Rapid Drug Assessment: Nicorette Quickmist oromucosal spray designated GREEN

Review:

Quetiapine tablets (Seroquel) and Quetiapine Modified Release tablets (Seroquel XL) AMBER

Venlafaxine Modified Release Formulations should be prescribed as one of the low cost brands: Depefex XL capsules, Ranfaxine XL capsules, Venaxx XL capsules or Venlalic XL tablets where possible

Angiotensin 2 Receptor Blocker Choice for Hypertension

NICE TA213: Aripiprazole for the treatment of schizophrenia in people aged 15 to 17 years (January 2011)

NICE TA218: Azacitidine for the treatment of myelodysplastic syndromes, chronic myelomonocytic leukaemia and acute myeloid leukaemia (March 2011)

New Trials in Brief: Olmesartan and fatal cardiovascular events; ACEI and A2RA combination therapy; Tiotropium versus salmeterol in COPD

MHRA Drug Safety Update (April 2011): Atypical antipsychotics: monitoring of weight, glucose and lipid levels

Description

Rapid Drug Assessment:

Calcipotriol 50 microgram/g and betamethasone 500 microgram/g gel (Dovobet) Licensed for scalp psoriasis and for mild to moderate non-scalp plaque psoriasis designated GREEN

Moxifloxacin hydrochloride 0.5% eye drops (Moxivig) Licensed for the topical treatment of purulent bacterial conjunctivitis designated RED-RED

Nicorette Fresh Mint Lozenges in adults and children over 12 years. It is also indicated for use in pregnant and lactating women designated GREEN

Review Prescribing of Dipipanone Licensed for moderate to severe pain designated RED-RED

New Trials in Brief: The ACCORD Study: Long term effects of intensive glucose lowering on cardiovascular outcomes

Donation of Patient-Returned Medicines to Charitable Organisations

Evaluation of the Scale, Causes and Costs of Waste Medicines

MHRA Drug Safety Update (March 2011): Modafinil (Provigil)

NICE TA212: Bevacizumab in combination with oxaliplatin and either fluorouracil plus folinic acid or capecitabine for the treatment of metastatic colorectal cancer (December 2010)

NICE TA214: Bevacizumab in combination with a taxane for the first-line treatment of metastatic breast cancer (February 2011)

NICE TA215: Pazopanib for the first-line treatment of advanced renal cell carcinoma (February 2011)

NICE TA216: Bendamustine for the first-line treatment of chronic lymphocytic leukaemia (February 2011)

NICE CG108: Chronic heart failure – Management of chronic heart failure in adults in primary and secondary care (August 2010)

Description

Review: Rasagiline (Azilect) tablets Licensed for the treatment of Parkinson’s disease used alone or as an adjunct to levodopa with dopa-decarboxylase inhibitor designated AMBER

New Drug Assessment: Amifampridine phosphate (Firdapse) tablets Licensed for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) in adults up to a maximum daily dose of 60mg. designated RED-RED

Rapid Drug Assessment:

Pigmanorm cream An unlicensed product used for the treatment of melanin-induced hyperpigmentation of the skin. Designated RED

Fenticonazole (Ginoxin) vaginal capsules 200mg, 600mg and 2% vaginal cream licensed for the treatment of vaginal candidiasis designated GREEN

Combined oral contraceptive pills - Rigevidon, Gedarel 20/150, Gedarel 30/150, Millinette 20/75, Millinette 30/75 and TriRegol Designated GREEN

NICE TA207 Temsirolimus for the treatment of relapsed or refractory mantle cell lymphoma (terminated appraisal) (October 2010)

NICE TA208: Trastuzumab for the treatment of HER2-positive metastatic gastric cancer (November 2010)

NICE TA209: Imatinib for the treatment of unresectable and/or metastatic gastrointestinal stromal tumours (November 2010)

NICE TA211: Prucalopride for the treatment of chronic constipation in women (December 2010)

NICE CG111: Nocturnal enuresis – The management of bedwetting in children and young people (October 2010)

New Trials in Brief: Statins for primary prevention of cardiovascular disease

MHRA Drug Safety Update: Daptomycin, Lenalidomide, Omalizumab, Peritoneal Dialysis Solutions

Description

Rapid Drug Assessment:

Aluminium chloride 15%/ salicylic acid 2% gel (Hydrosal) Treatment of axillary hyperhidrosis (unlicensed) designated RED-RED

Sodium Chloride Nebuliser Solution 7% (Nebusal) (Hypertonic Saline) used to mobilise lower respiratory tract secretions in mucous consolidation (e.g. cystic fibrosis) Designated AMBER

Naproxen 500mg/esomeprazole 20mg tablets (Vimovo) Licensed for the symptomatic treatment of osteoarthritis (OA), rheumatoid arthritis and ankylosing spondylitis in patients at risk of NSAID associated gastric and or duodenal ulcers in whom lower doses of naproxen or other NSAIDs are not sufficient designated RED-RED

Etonogestrel (Nexplanon) 68mg subdermal implant designated GREEN

NICE TA197: Dronedarone for the treatment of non-permanent atrial fibrillation (August 2010)

NICE TA210: Clopidogrel and modified release dipyridamole for the prevention of occlusive vascular events (December 2010)

New Trials in Brief: Review of orlistat prescribing; Cardiovascular safety of NSAIDs

MHRA Drug Safety Update: Fibrates – not recommended first line (December 2010)

Description

Review: Pramipexole prolonged release tablets (Mirapexin) and Ropinirole modified release tablets (ReQuip XL) for Parkinson’s Disease designated AMBER

NICE TA200: Peginterferon alfa and ribavirin for the treatment of chronic hepatitis C (September 2010)

NICE TA201: Omalizumab for the treatment of severe persistent allergic asthma in children aged 6 to 11 years (October 2010)

NICE TA203: Liraglutide for the treatment of type 2 diabetes mellitus (October 2010)

NICE TA204 Denosumab for the prevention of osteoporotic fractures in postmenopausal women (October 2010)

New Trials in Brief: Reboxetine –an ineffective antidepressant?; Omacor and the OMEGA study; Glucosamine – the final chapter?

MHRA Drug Safety Update: Tamoxifen drug interactions; Memantine pump device (Ebixa) – risk of medication erros; Oral bisphosphonates and oesophageal cancer; Tiotropium –safety studies of Spiriva Respimat

Description

Review: Atorvastatin 80mg and Acute Coronary Syndrome approved for use in patients at high risk subject to cardiologist initiation and review and step-down at six months

Review: Standard prednisolone tablets versus enteric coated prednisolone tablets. Prescribers are urged to use standard prednisolone tablets first line and to consider switching existing patients on EC to standard prednisolone

Rapid Drug Assessment: Prednisone modified release tablets (Lodotra) classified RED-RED

NICE TA202: Ofatumumab for the treatment of chronic lymphocytic leukaemia refractory to fludarabine and alemtuzumab (October 2010)

NICE TA205: Eltrombopag for the treatment of chronic immune (idiopathic) thrombocytopenic purpura (October 2010)

NICE TA206: Bendamustine for the treatment of indolent (low grade) non-Hodgkin’s lymphoma that is refractory to rituximab (terminated appraisal) (October 2010)

MHRA Drug Safety Update (September 2010): Isotretinoin - risk of serious skin reactions; Risk of psychological and behavioural side effects with inhaled and intranasal corticosteroids; Long-acting beta 2 agonists in asthma

MHRA Drug Safety Update (October 2010): Implanon contraceptive implant - changing to Nexplanon; Codeine-containing liquid over-the-counter medicines – no longer recommended for cough in the under 18s