MHRA
People impersonating MHRA staff have been calling on drug companies, says the MHRA. It is reminding staff at drug companies to check out the credentials of individuals claiming to be from the agency. It asks people to call its central enquiry point on 0207 084 2000 if they don’t recognise the name of the caller and to double check if they are genuine before giving out information.
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The MHRA has published guidance defining its role when validating applications on authorisation of medicines for children. When applications are submitted and no previous compliance check has taken place, the MHRA will refer national applications or where the UK is a reference member state, to the Paediatric Committee to check out whether the research carried out by the applicant is in compliance with the agreed Paediatric Investigation Plan.
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Hospital staff should ensure that faulty 24 hour urine collection bottles are taken out of circulation in their departments and returned to the manufacturer, advises the MHRA. The bottles, made by Technical Services Consultants Ltd with code PLYSU, have necks incompatible with the bottle cap causing them to leak when used. A new stock has since been designed and NHS Supply Chain has worked to replace the old stock with the new.
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Cochrane Library
People that regularly use salmeterol for asthma are at a greater risk of non-fatal adverse events than those using dummy inhalers, find researchers who looked at 26 trials involving 62,630 patients. Over four to six months, for every thousand asthmatics treated there were 45 who suffered a serious adverse event on regular salmeterol, compared with only 40 using a placebo inhaler. People should not increase the dose of salmeterol during an exacerbation, the authors, advised and regular salmeterol should not be used as an alternative to inhaled corticosteroids.
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Custom-made insoles known as orthotics can reduce foot pain due to arthritis, prominent big toe joints, and highly arched feet, finds a systematic review, which looked at 11 trials involving 1,332 people. Orthotics relieved pain in adults with rheumatoid arthritis and children with juvenile idiopathic arthritis. However, more research is needed to find out exactly how effective they are and for how long.
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Being able to remove casts or splints following ankle surgery aids recovery, a Cochrane review has shown. People can then exercise their ankle and if the fracture is stable, they should also be encouraged to walk.
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EMEA
The Agency’s Committee for Medicinal Products for Human Use has recommended the granting of a marketing authorisation, for the new medicinal product: Evicel (human fibrinogen/human thrombin).
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Use of medicines containing oral moxifloxacin should be restricted following concerns over their liver safety, says the EMEA. The products should only be used for treating acute bacterial sinusitis, acute exacerbation of chronic bronchitis and community-acquired pneumonia when other antibiotics have failed. And warnings on all treatments containing the antibiotic should also be strengthened, flagging up risks of diarrhoea, heart failure in women and older patients, severe skin reactions, and fatal liver injury.
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Ethyl methansulfonate, found in the HIV medication, nelfanvir mesylate does not increase patients’ risk of developing cancer, says the EMEA.
Its Committee for Medicinal Products for Human Use confirmed this following research on ethyl methansulfonate.
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Clinicians should not use norfloxacin-containing products for kidney infections, recommends the EMEA. It has recommended withdrawing the marketing authorisation of such products for the treatment of acute or chronic complicated pyelonephritis as risks outweigh its benefits. The change follows a request by the Belgian medicines regulatory agency that questioned its use for complicated kidney infections with comparison to other fluroquinolone antibiotics.
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FDA
The FDA has approved the first generic versions of Depakote (divalproex sodium) delayed-release tablets for seizures, bipolar disorder, and migraine headaches. The generic versions will carry the same safety warnings as Depakote, including warnings on risks of liver damage, pancreatitis, deaths, and risk of birth defects.
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