Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Drug Safety Update - December 2014

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for December 2014 (PDF).

The drug safety section in this issue contains new advice for healthcare professionals when using ivabradine (Procoralan®) in the treatment of symptomatic angina. This medication has been linked with bradycardia, atrial fibrillation and other cardiovascular risks and the following new recommendations have been made.

  • Only start ivabradine if the resting heart rate is at least 70 beats per minute
  • Do not prescribe ivabradine with other medicines that cause bradycardia, such as verapamil, diltiazem or strong CYP3A4 inhibitors
  • Monitor patients regularly for atrial fibrillation. If atrial fibrillation occurs, carefully reconsider whether the benefits of continuing ivabradine treatment outweigh the risks
  • Consider stopping ivabradine if there is no or only limited symptom improvement after 3 months

This section also reminds clinicians of the risk of psychiatric disorders with isotretinoin (Roaccutane®). Clinicians are reminded that this medicine should only be prescribed under specialist supervision and that the patients and their family should be warned that the treatment might cause psychiatric disorders such as depression, anxiety, and in rare cases suicidal thoughts. Reporting of such symptoms should be encouraged and appropriate action taken if they arise; simply stopping isotretinoin may not be enough to alleviate symptoms.

Action: Clinicians will find this publication to be a useful review of current issues in drug safety.

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SMC Update - December 2014

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

Cholecalciferol 25,000iu solution (InVita D3®) has been accepted for the the prevention and treatment of vitamin D deficiency.

Clindamycin / Tretinoin gel (Treclin®) has been accepted for the for the topical treatment of acne vulgaris when comedones, papules and pustules are present in patients 12 years or older.

Dolutegravir / Abacavir / Lamivudine (Triumeq®) has been accepted for the treatment of Human Immunodeficiency Virus (HIV) infected adults and adolescents above 12 years of age weighing at least 40 kg. It is noted that in patients for whom this combination is appropriate, it offers a single tablet at a lower cost per dose compared with the individual components.

Indacaterol / Glycopyrronium (Ultibro Breezhaler®) has been accepted for use as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). It is noted that for patients for whom this combination is appropriate, this product provides the two ingredients in a single hard capsule at a lower cost than the individual components.

Umeclidinium (Incruse®) has been accepted for use as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). Recent studies of 12 and 24 weeks duration have demonstrated improvements in lung function and symptoms (such as dyspnoea) when compared with placebo. It is noted that umeclidinium is an alternative to other long-acting muscarinic antagonists (LAMAs).

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 - November 2014

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for November 2014 (PDF).

The drug safety section in this issue reminds clinicians that agomelatine (Valdoxan®) may cause liver toxicity in some people and that liver function should be tested before and during treatment. It is recommended that treatment is stopped if serum transaminases exceed three times the upper limit of normal and that patients are advised to stop taking agomelatine and to get medical help immediately if they have any signs or symptoms of liver injury. This section also reports that there have been reports of Colobreathe® (colistimethate sodium) capsules shattering when pierced by their inhaler device. The instructions for inhaler use have been revised and it is recommended that the new inhaler is demonstrated to patients and carers and that the first dose is supervised.

The stop press section reminds readers of the risk of ingestion of desiccants in blister packs. There have been two reports recently of people swallowing the desiccant that came with their nicorandil tablets instead of the tablet itself. It is noted that the foil blister and patient information leaflet clearly advise people not to swallow the desiccant. It is recommended that people receiving blister packs containing a desiccant are reminded the desiccant should not be swallowed.

The other information section advises that the arrangements for email alerts about Drug Safety Update are changing. Current subscribers can check their settings at https://service.govdelivery.com/accounts/UKMHRA/subscriber/new.

Action: Clinicians will find this publication to be a useful review of current issues in drug safety.

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SMC Update - November 2014

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

Brinzolamide and brimonidine eye drops (Simbrinza®) have been accepted for use to decrease of elevated intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction. It is noted that this combination is not significantly more expensive and allows patients to administer fewer drops.

Denosumab (Prolia®) has been rejected for the treatment of osteoporosis in men at increased risk of fractures. The manufacturer failed to make a submission and as a result this treatment cannot be recommended.

Saxagliptin (Onglyza®) has been accepted for use in adult patients aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control as combination therapy with insulin (with or without metformin), when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.

Voriconazole (Vfend®) has been rejected for the prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (HSCT) recipients. The manufacturer failed to make a submission and as a result this treatment cannot be recommended.

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 - October 2014

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for October 2014 (PDF).

The drug safety section in this issue advises clinicians that there have been reports of thrombotic microangiopathy and nephrotic syndrome linked to interferon beta treatment. Clinicians should be vigilant for early signs or symptoms of these conditions and treat these conditions promptly if they occur.

This section also advises that with effect from October 2014 dexamethasone 4mg/ml injection is being replaced by a 3.8mg/ml product. It has a different manufacturer and as such the storage conditions, presentation, and packaging will change.

Other information also clarifies that new laws that set blood concentration limits to be set for certain controlled drugs are only applicable in England, Scotland and Wales. In Northern Ireland a similar offence is under consideration. This new law applies to the following medicines:

  • Cannabis (tetrahydrocannabinol, THC)
  • Cocaine
  • Morphine
  • Diamorphine
  • Methadone
  • Ketamine
  • Amphetamine
  • Flunitrazepam
  • Clonazepam
  • Diazepam
  • Lorazepam
  • Oxazepam
  • Temazepam

Patients should be advised that it is against the law to drive if your driving ability is impaired by a medicine and not to drive while taking a medicine until you know how it affects you (especially just after starting or changing the dose of the medicine) or if feeling sleepy, dizzy, unable to concentrate or make decisions, or if there is blurred or double vision.

Action: Clinicians will find this publication to be a useful review of current issues in drug safety.

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