Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Drug Safety Update - January 2015

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for January 2015. This month there are six updates.

There is new information and strengthened warnings related to safety of medicines containing valproate derivatives (sodium valproate, valproic acid and valproate semisodium), following completion of a Europe-wide review. It is noted that children exposed in utero to valproate are at a high risk of serious developmental disorders (in up to 30-40% of cases) and/or congenital malformations (in approximately 10% of cases). It is recommended that valproate should not be prescribed to female children, female adolescents, women of childbearing potential or pregnant women unless other treatments are ineffective or not tolerated. It is also recommended that treatment is started and supervised by a specialist and that all female patients are informed of and understand the risks.

Ustekinumab (Stelara®) has been associated with exfoliative dermatitis. Clinicians are advised to be alert for signs and symptoms of exfoliative dermatitis. If exfoliative dermatitis is suspected to have been caused by an adverse drug reaction to ustekinumab treatment must be stopped.

Mycophenolate has been linked with an increased risk of hypogammaglobulinaemia and bronchiectasis. Clinicians are advised to measure serum immunoglobulin levels if recurrent infections develop and to consider bronchiectasis or pulmonary fibrosis if patients develop persistent respiratory symptoms, such as cough and dyspnoea.

Oral diclofenac is now no longer available without prescription due to an increased risk of cardiovascular side effects.

Prescribing advice for aceclofenac (Preservex®) has been updated in line with diclofenac and COX-2 inhibitors. It is now contraindicated in people with vascular disease and heart disease. Patients with these conditions who are prescribed aceclofenac should be switched to a safer alternative as their next routine appointment.

Lastly readers are advised that the Yellow Card scheme has been extended to include devices, counterfeits and defective medicines. Previously there were separate reporting systems in place for such instances. The reporting systems have now been simplified.

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

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MTRAC Reviews - December 2014

MTRAC issued an updated Commissioning Support guidance in December 2014. The review covers fluticasone / formoterol inhaler.

The fluticasone / formoterol inhaler (Flutiform®) summary advises that this combination inhaled corticosteroid / long-acting beta agonist inhaler is suitable for prescribing in primary care for the treatment of asthma. It is noted that in two 12-week RCTs, flutiform was found to be non-inferior to a fluticasone / salmeterol inhaler (Seretide®), and a budesonide / formoterol inhaler (Symbicort®) respectively for the primary outcome of change in pre-dose FEV1 from baseline.

Action: Clinicians should be aware of these reviews and use the recommendations to guide appropriate use of these medicines in current practice.

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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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