Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Drug Safety Update - August 2015

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

Clinicians are advised that amiodarone use has been associated with severe bradycardia and heart block when used with simeprevir (Olysio®) and sofosbuvir (Sovaldi®) combination therapy for chronic hepatitis C. Amiodarone is only recommended in this combination when all other antiarrhythmics cannot be given. When there is no alternative very careful monitoring is recommended. Patients should be advised to report symptoms of bradycardia including shortness of breath, light-headedness, palpitations and fainting.

Finally this month there is a summary of letters sent to healthcare professionals in July 2015, including one regarding the risk of diabetic ketoacidosis observed with SGLT2 inhibitors and one regarding the new contraindication for denosumab in patients with unhealed lesions from dental or oral surgery and the introduction of patient safety cards about osteonecrosis of the jaw. Both of these items have been covered in previous Drug Safety Updates.

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

Share 'Drug Safety Update - August 2015' on Email Share 'Drug Safety Update - August 2015' on Delicious Share 'Drug Safety Update - August 2015' on Digg Share 'Drug Safety Update - August 2015' on Facebook Share 'Drug Safety Update - August 2015' on Google+ Share 'Drug Safety Update - August 2015' on reddit Share 'Drug Safety Update - August 2015' on StumbleUpon Share 'Drug Safety Update - August 2015' on Twitter

SMC Update - August 2015

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

Darunavir / Cobicistat (Rezolsta®) has been accepted for use in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years or older. Genotypic testing should guide its use.

Tedizolid (Sivextro®) has been accepted for restricted use in the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults. The restriction limits use to patients with ABSSSI caused by Gram-positive Staphylococcus aureus (specifically methicillin-resistant Staphylococcus aureus [MRSA] isolates as an alternative oxazolidinone antibacterial on the specific advice of local microbiologists or specialists in infectious disease.

Tiotropium solution for inhalation (Spiriva® Respimat®) is accepted for use as an add-on maintenance bronchodilator treatment in adult patients with asthma who are currently treated with the maintenance combination of inhaled corticosteroids (≥800 micrograms budesonide/day or equivalent) and long-acting beta2 agonists and who experienced one or more severe exacerbations in the previous year.

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

Share 'SMC Update - August 2015' on Email Share 'SMC Update - August 2015' on Delicious Share 'SMC Update - August 2015' on Digg Share 'SMC Update - August 2015' on Facebook Share 'SMC Update - August 2015' on Google+ Share 'SMC Update - August 2015' on reddit Share 'SMC Update - August 2015' on StumbleUpon Share 'SMC Update - August 2015' on Twitter

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.

Share 'Drug Safety Update - July 2015' on Email Share 'Drug Safety Update - July 2015' on Delicious Share 'Drug Safety Update - July 2015' on Digg Share 'Drug Safety Update - July 2015' on Facebook Share 'Drug Safety Update - July 2015' on Google+ Share 'Drug Safety Update - July 2015' on reddit Share 'Drug Safety Update - July 2015' on StumbleUpon Share 'Drug Safety Update - July 2015' on Twitter

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.

Share 'SMC Update - July 2015' on Email Share 'SMC Update - July 2015' on Delicious Share 'SMC Update - July 2015' on Digg Share 'SMC Update - July 2015' on Facebook Share 'SMC Update - July 2015' on Google+ Share 'SMC Update - July 2015' on reddit Share 'SMC Update - July 2015' on StumbleUpon Share 'SMC Update - July 2015' on Twitter

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.

Share 'NovoPen 4 to be phased out' on Email Share 'NovoPen 4 to be phased out' on Delicious Share 'NovoPen 4 to be phased out' on Digg Share 'NovoPen 4 to be phased out' on Facebook Share 'NovoPen 4 to be phased out' on Google+ Share 'NovoPen 4 to be phased out' on reddit Share 'NovoPen 4 to be phased out' on StumbleUpon Share 'NovoPen 4 to be phased out' on Twitter

« Older Posts

Prescribing Advice for GPs is powered by WordPress.
Subscribe for Free to our RSS or Atom Feeds for New Entries.
Akismet has protected Prescribing Advice for GPs from 787,939 spam comments.

atomic-wealth
fond-illness
summer