Drug and Therapeutics Update

Monday, 10 November 2008

NICE

GPs should get involved in providing walking schemes for their older patients, recommends NICE in its latest public health intervention guidance. Alongside local authorities and leisure services, they should work with people over the age of 65 to offer walking schemes of varying difficulty over a range of local routes. Promotion through advertising in the surgery and communication during appointments will help raise and maintain older people’s awareness of the need to keep active. The schemes should be led by trained workers or ‘Walking the way to health’ initiative walk leaders who know first aid and suitable routes. Walks should be offered at least three times a week, last about one hour and include at least 30–40 minutes of walking plus stretching and warm-up/cool-down exercises.


MHRA

Merck Sharp & Dohme has written to doctors advising them to ensure that etoricoxib is not used in patients with blood pressure persistently above 140/90 mmHg. The company also reminds clinicians that all patients starting treatment with etoricoxib should have their blood pressure monitored within 2 weeks after starting treatment and periodically. This follows the European Medicines Agency’s recent review on the benefits and risks of 90 mg etoricoxib in the treatment of rheumatoid arthritis and in ankylosing spondylitis, which suggested that many patients with systolic BP >150mmHg and/or diastolic BP >90mmHg have been initiated on etoricoxib despite earlier recommendations. The company says these changes have to now be incorporated into the UK licences for etoricoxib and a revised Summary of Product Characteristics will follow later this year.

Separately, Sanofi-aventis reminds health professionals in a letter that they should not prescribe rimonabant due to possible psychiatric side-effects. Its marketing authorisation was suspended by the EMEA last month. Doctors should not issue, renew, or dispense any prescriptions for the drug.


EMEA

Eszopiclone, under the brand name Lunivia from Sepracor Pharmaceuticals Ltd, has been given a positive view over its use for insomnia in adults at its meeting of the Committee for Medicinal Products for Human Use last month.

Also receiving a positive opinion was azacitidine (Vidaza), from Celgene Europe Ltd, for the treatment of myelodysplastic syndromes and acute myeloid leukaemia in adults who are not eligible for haematopoietic stem-cell transplantation, and pramipexole (Pramipexole Teva), from Teva Pharma B.V., for the treatment of idiopathic Parkinson’s disease, alone or in combination with levodopa.

The CHMP also reversed its initially negative opinion on recombinant human osteogenic protein-1/eptotermin alfa (Opgenra), from Howmedica International S. de R.L. for posterolateral lumbar spinal fusion in adult patients with spondylolisthesis where autograft has failed or is contraindicated. 


FDA

A new drug for overactive bladder in adults has been approved by the FDA. Fesoterodine fumarate (Toviaz) relaxes bladder smooth muscle tissue, reducing urinary frequency, urge to urinate and sudden urinary incontinence. The product will be available on prescription as an extended release tablet in either 4 mg or 8 mg doses for daily administration. The recommended starting dose is 4 mg, which can be increased to 8 mg if needed, based upon individual response and tolerability. Common side effects are dry mouth and constipation.