Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Drug Safety Update - July 2016

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for July 2016 (PDF).

This issue highlights very rare reports of calciphylaxis in patients taking warfarin. This is a very serious condition causing vascular calcification and skin necrosis most commonly observed in patients with end-stage renal disease on dialysis, or in those with known risk factors such as protein C or S deficiency, hyperphosphataemia, hypercalcaemia or hypoalbuminaemia. However, cases have been reported in patients taking warfarin, including those with normal renal function, and evidence suggests that on rare occasions warfarin use might lead to calciphylaxis.

This issue also notes the possibility of an interaction between citalopram and cocaine suggested in a Coroner's report after the death of a man due to subarachnoid haemorrhage. There are plausible mechanisms for an interaction between cocaine and citalopram that could lead to subarachnoid haemorrhage, including hypertension related to cocaine and an additive increased bleeding risk in combination with citalopram. Possible illicit drug use should be considered when making prescribing decisions and prescribers should consider enquiring about illicit drug use.

N-acetylcysteine may interfere with assays from Siemens ADVIA Chemistry and Dimension/Dimension Vista instruments, leading to false-low biochemistry test results. Local laboratories should already be aware of this issue however it may be prudent to indicate to laboratories any patients who are taking N-acetylcysteine.

Finally this month there is a summary of letters sent to healthcare professionals in June.

Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.

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SMC Update - July 2016

The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.

Brivaracetam (Briviact®) has been accepted for restricted use as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adult and adolescent patients from 16 years of age with epilepsy. The restriction limits use to patients with refractory epilepsy and treatment should be initiated by physicians who have appropriate experience in the treatment of epilepsy.

Vortioxetine (Brintellix®) has been accepted for restricted use in the treatment of major depressive episodes in adults. The restriction limits use to patients who have experienced an inadequate response (either due to lack of adequate efficacy and/or safety concerns/intolerability) to two or more previous antidepressants.

Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.

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Drug Safety Update - June 2016

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for June 2016 (PDF).

This issue highlights the recently identified signal of increased risk of lower extremity amputations observed in trial in high cardiovascular risk patients taking canagliflozin (Invokana® or Vokanamet®). The following recommendations are made:

  • as a precaution, consider stopping canagliflozin if a patient develops a significant lower limb complication (e.g. skin ulcer, osteomyelitis, or gangrene), at least until the condition has resolved, and continue to monitor the patient closely
  • carefully monitor patients receiving canagliflozin who have risk factors for amputation (e.g. previous amputations, existing peripheral vascular disease, or neuropathy)
  • monitor all patients for signs and symptoms of water or salt loss; ensure patients stay sufficiently hydrated to prevent volume depletion in line with recommendations in the product information; note that diuretics can exacerbate dehydration
  • advise patients to stay well hydrated, carry out routine preventive foot care and seek medical advice promptly if they develop skin ulceration, discolouration, or new pain or tenderness
  • start treatment for foot problems (e.g. ulceration, infection, or new pain or tenderness) as early as possible

This issue informs clinicians that there have been rare reports of etonogestrel implants (Nexplanon®) having reached the lung via the pulmonary artery. It is recommended that an implant that cannot be palpated at its insertion site in the arm should be located as soon as possible and removed at the earliest opportunity. If an implant cannot be located within the arm, perform chest imaging. A letter has been sent direct to healthcare professionals about this safety concern.

This issue also reminds clinicians of the potential for miconazole containing medications to have serious interactions with warfarin. There have been reports of serious bleeding events in patients taking the combination and the risk extends to miconazole oral gel. The available data for this interaction are being reviewed to determine whether further measures are required to minimise the risks to patients.

Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.

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SMC Update - June 2016

The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.

Co-careldopa intestinal gel (Duodopa®) has been accepted for restricted use in the treatment of advanced levodopa-responsive Parkinson's disease with severe motor fluctuations and hyper-/dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results. The restriction limits use to patients who are not eligible for deep brain stimulation.

Evolocumab (Repatha®) has been rejected for use:

  • in adults with primary hypercholesterolaemia
  • in combination with a statin or statin with other lipid lowering therapies in patients unable to reach low density lipoprotein-cholesterol (LDL-C) goals
  • alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated
  • in adults and adolescents aged 12 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies

The submitting company did not present a sufficiently robust clinical and economic analysis to gain acceptance by SMC.

Febuxoxtat (Adenuric®) has been accepted for restricted use in the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumour Lysis Syndrome (TLS). The restriction limits use to patients in whom allopurinol is either unsuitable or contraindicated.

Naproxen effervescent tablets (Stirlescent®) have been accepted for restricted use in the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute musculoskeletal disorders, dysmenorrhoea and acute gout in adults. The restriction limits use to patients who are unable to swallow naproxen tablets.

Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.

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Bydureon device change

The manufacturer of exenatide once weekly (Bydureon®) has written to healthcare providers advising that the original 'vial and syringe' kit is being replaced by a pre-filled pen.

The pen has been available for several months and is designed to make administration easier for patients. According to the letter, the older formulation will be phased out later this year. Any patient who is starting this treatment should be supplied with the pen device. This is indicated as 'pre-filled pen' or 'pre-filled disposable device' in the item description on clinical systems. Patients who are currently prescribed the vials should be moved to the new device.

Patient information about the switch is available at talkingtype2.co.uk [acceptance of legal, privacy and cookie terms required] and the Patient Information Leaflet describes how to use the new device.

Action: Clinicians should be aware that the vial and syringe kit is being replaced. It would be prudent to run clinical system searches to identify any patients who are currently prescribed the vials so prescriptions can be updated.

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