Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Drug Safety Update - July 2015

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for July 2015 (PDF).

Patient reminder cards about the risk of osteonecrosis of the jaw are being introduced for Denosumab (Prolia®, Xgeva®) and intravenous bisphosphonates. Additionally, denosumab 120mg (Xgeva®) is now contraindicated in patients with unhealed lesions from dental or oral surgery.

The Xalatan® formulation of latanoprost has recently been changed such that the pH is now 6.0 compared to 6.7 previously. This change allows for longer term storage at room temperature however it has also been associated with an increase in reporting of eye irritation. Patients as advised to tell their health professional promptly (within a week) if they have eye irritation (e.g. excessive watering) severe enough to make them consider stopping treatment.

There is a new App for reporting adverse drug reactions via a yellow card for both the iOS and Android platforms.

Finally this month there is a summary of letters sent to healthcare professionals in June 2015, including one for the oral anticoagulant edoxaban.

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 2015

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

Adalimumab (Humira®) has been accepted for restricted use in the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. The restriction limits use individuals with severe disease as defined by a total Psoriasis Area Severity Index (PASI) score of ≥10 and a Dermatology Life Quality Index (DLQI) of >10.

Riociguat (Adempas®) has been accepted for restricted use in the treatment of pulmonary arterial hypertension (PAH) as monotherapy or in combination with endothelin receptor antagonists in adult patients with World Health Organisation Functional Class (WHO FC) II to III to improve exercise capacity. It is restricted to initiation and prescribing by specialists in the Scottish Pulmonary Vascular Unit or by similar specialists.

Rivaroxaban (Xarelto®) has been rejected for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers in combination with aspirin alone or with aspirin plus clopidogrel or ticlopidine. The submitting company did not present a sufficiently robust economic analysis to gain acceptance by SMC.

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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NovoPen 4 to be phased out

The manufacturer of NovoPen® 4 has written to healthcare professionals advised that this device is being phased out and replaced by NovoPen® 5.

It is expected that supplies of the NovoPen® 4 will run out in September 2015. The new device will be available in the same colours (blue and silver) and has a memory function which displays the number of units last injected and gives an indication of the amount of time that has passed since the last injection.

Action: Clinicians should be aware of this product being discontinued and ensure that future prescriptions are issued for the replacement device.

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Drug Safety Update - June 2015

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for June 2015 (PDF).

SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin) have been linked with an increased risk of diabetic ketoacidosis (DKA) even when plasma glucose levels are near-normal. It is recommended that patients presenting with symptoms of acidosis are tested for raised ketones and that SGLT2 inhibitors are stopped if DKA is suspected.

A recent review of the safety of high dose ibuprofen (>2400mg per day) has identified cardiovascular risks similar to COX 2 inhibitors and diclofenac. It is recommended that high dose ibuprofen is avoided in people with cardiovascular diseases (including ischaemic heart disease, peripheral arterial disease, cerebrovascular disease, congestive heart failure and uncontrolled hypertension). Individuals with these conditions who are already taking high dose ibuprofen should be reviewed at their next routine appointment.

Clinicians are also advised to inform women of the risks of uterine perforation before inserting an intrauterine system (IUS) or intrauterine device (IUD). It is noted that perforation occurs in less than 1 in 1,000 women and that the symptoms include:

  • severe pelvic pain after insertion (worse than period cramps)
  • pain or heavy bleeding after insertion which continues for more than a few weeks
  • sudden changes in periods
  • pain during sex
  • not being able to feel the threads

It is advised that women are told to report any of the above symptoms and also advised how to check their threads and are told to return for a check-up if they cannot feel them.

Finally there are requests to complete a survey of medicines safety communications which examines user experience of regulatory safety communications, views on their effectiveness and the information channels users prefer. There is also a call for any evidence considered relevant to a possible association between the use of oral hormonal pregnancy tests, which were available until the late 1970s, and adverse effects on pregnancy or birth defects.

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 2015

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

Apremilast (Otezla®) has been accepted for use in the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including ciclosporin, methotrexate or psoralen and ultraviolet-A light (PUVA).

Apremilast (Otezla®) has been accepted for restricted use alone or in combination with disease modifying anti-rheumatic drugs (DMARDs), for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy. The restriction limits use to patients who have had an inadequate response with at least two prior DMARD therapies or who are intolerant to such therapies.

Levonorgesterel (Levosert®) has been accepted for use as a contraceptive or in heavy menstrual bleeding. It is noted that this product contains the same total amount of levonorgestrel with the same release profile as an existing levonorgestrel-containing IUS at a lower unit cost.

Linagliptin and metformin (Jentadueto®) has been accepted for restricted use in the treatment of adult patients with type 2 diabetes mellitus in combination with insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control when insulin and metformin alone do not provide adequate glycaemic control. The restriction limits use to patients where a combination of linagliptin and metformin is an appropriate choice of therapy and the fixed doses are considered appropriate.

Magnesium aspartate dehydrate (Magnaspartate®) has been accepted for the treatment and prevention of magnesium deficiency, as diagnosed by a doctor.

Ombitasvir / paritaprevir / ritonavir (Viekirax®) and dasabuvir (Exviera®) have been accepted for use with or without ribavirin for the treatment of genotype 1 chronic hepatitis C (CHC) in adults and in combination with ribavirin for the treatment of genotype 4 CHC in adults.

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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