MHRA new restrictions and precautions for fluoroquinolone antibiotics
26th March 2019
New restrictions and precautions for use of fluoroquinolone antibiotics (ciprofloxacin, levofloxacin, moxifloxacin and ofloxacin) are being introduced following very rare reports of potentially irreversible undesirable effects affecting the musculoskeletal and nervous systems.
The following advice for healthcare professionals has been published:
- systemic fluoroquinolones can very rarely cause long-lasting (up to months or years), disabling, and potentially irreversible undesirable effects, sometimes affecting multiple systems, organ classes, and senses
- advise patients to stop treatment at the first signs of a serious undesirable effect, such as tendinitis or tendon rupture, muscle pain, muscle weakness, joint pain, joint swelling, peripheral neuropathy, and central nervous system effects, and to contact their doctor immediately for further advice
- do not prescribe fluoroquinolones:
- for non-severe or self-limiting infections, or non-bacterial conditions
- for some mild to moderate infections (such as in acute exacerbation of chronic bronchitis and chronic obstructive pulmonary disease, see updated SPC indications) unless other antibiotics that are commonly recommended for these infections are considered inappropriate
- ciprofloxacin or levofloxacin should no longer be prescribed for uncomplicated cystitis unless other antibiotics that are commonly recommended are considered inappropriate (see updated SPC indications)
- avoid use in patients who have previously had serious adverse reactions with a quinolone or fluoroquinolone antibiotic
- prescribe with special caution for people > 60 years and for those with renal impairment or solid-organ transplants because they are at a higher risk of tendon injury
- avoid use of a corticosteroid with a fluoroquinolone since coadministration could exacerbate fluoroquinolone-induced tendinitis and tendon rupture
- report suspected undesirable effects to fluoroquinolone antibiotics via the MHRA yellow card scheme.
Glycopyrronium 1mg/5mL oral solution updated indications
14th March 2019
Glycopyrronium bromide 1mg/5mL oral solution (Colonis Pharma) is now authorized for the treatment of severe sialorrhoea in children and adolescents ≥ 3 years with chronic neurological disorders. Previously, only the Sialanar product (Glycopyrronium bromide 2mg/5mL) was authorized for this indication (see our news item).
Cochrane review: Pregabalin for neuropathic pain
4th March 2019
A review update, for an earlier Cochrane review in 2009, for the use of pregabalin for neuropathic pain in adults has not shown an substantial change from the original findings. The authors’ concluded:
“Evidence shows efficacy of pregabalin in postherpetic neuralgia, painful diabetic neuralgia, and mixed or unclassified post-traumatic neuropathic pain, and absence of efficacy in HIV neuropathy; evidence of efficacy in central neuropathic pain is inadequate. Some people will derive substantial benefit with pregabalin; more will have moderate benefit, but many will have no benefit or will discontinue treatment.”
Pharmacies now able to dispense controlled drugs via the Electronic Prescription Service
4th March 2019
NHS Digital is rolling out prescribing Schedule 2 and 3 controlled drugs, except oral liquid methadone, via the Electronic Prescription Service, following a successful trial in GP practices.
Gosport report: Pharmacy bodies publish a reflection and learning resource
3rd March 2019
The General Pharmaceutical Council, Royal Pharmaceutical Society and Association of Pharmacy Technicians in the UK have joined together to publish a reflection and learning resource to support pharmacy to learn the lessons from the Gosport Independent Panel report, which was published in June 2018.
In addition, the Royal Pharmaceutical Society’s Hospital Expert Advisory Group has published a discussion paper on areas requiring action.
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