NPC Archive Item: MHRA Drug Safety Update October 2011

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17 October 2011

The MHRA and CHM have published the October edition of Drug Safety Update. This edition details the new restrictions and monitoring requirements for dronedarone (Multaq▼), advises care when transferring patients to the newly authorised buccal midazolam product (Buccolam▼) from previously used unlicensed medicines, and recommends no changes to the prescribing of calcium and vitamin D supplements despite concerns about increased cardiovascular risk raised in a recent meta-analysis.

Drug Safety Update is an essential read for everyone whose professional practice involves medicines. It is published every month in electronic format only.

As reported in MeReC Rapid Review No. 4451, following new evidence of cardiovascular, hepatic and pulmonary safety, a review of dronedarone by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of treatment continue to outweigh the risks for the maintenance of sinus rhythm after successful cardioversion in a limited population of patients with paroxysmal or persistent atrial fibrillation. However, in light of safety concerns dronedarone should only be prescribed after other treatment options have been considered. To support safer use, patients should have their treatment reviewed at the next routine appointment to ensure that they remain eligible for dronedarone treatment according to the revised prescribing information, including new restrictions on use.

Dronedarone should not be given to patients with left ventricular systolic dysfunction, or to patients with current or previous episodes of heart failure. The CHMP considered that treatment with dronedarone should be initiated and monitored only under specialist supervision. A number of further contraindications for use and recommendations for monitoring were also endorsed by the CHMP. Regular monitoring of cardiac, liver, pulmonary and renal function during treatment is recommended.

Buccal midazolam (Buccolam)
Buccal midazolam (Buccolam) is a new authorised treatment for prolonged acute convulsive seizures. It is now available on the UK market. Buccal midazolam may be considered as an alternative to rectal diazepam for the treatment of prolonged seizures. Several factors should be considered when transferring patients to the authorised Buccolam product when an unlicensed medicine other than Buccolam has been used previously.

Buccolam is half the strength of some other unlicensed preparations. It contains the hydrochloride salt, whereas some other preparations contain the maleate salt of midazolam. Although there is some suggestion that the maleate salt may be better absorbed in the buccal cavity, there are adequate studies with midazolam hydrochloride to support the dosing schedule authorised for Buccolam.

Calcium and vitamin D
A recent meta-analysis has raised concerns about a possible modest increase in the risk of some cardiovascular events in postmenopausal women who use calcium and vitamin D supplements to prevent osteoporotic fractures. However, there are limitations to the data and no change to prescribing practice is currently recommended. This study was reviewed in MeReC Rapid Review No. 3859.

The MHRA has issued the following advice for healthcare professionals:

  • Prescribers should consider the potential benefits and risks of using calcium and vitamin D for prevention of osteoporotic fractures on an individual basis in line with NICE guidance on drugs for the primary or secondary prevention of osteoporosis. Prescribers should consider offering these supplements to postmenopausal women who receive treatment for osteoporosis (e.g., with bisphosphonates), unless they are confident that the patient has an adequate calcium intake and is vitamin D replete.
  • The National Osteoporosis Society advises that increasing dietary intake in those with low intakes of calcium and vitamin D is considered preferable to supplements. They also advise that supplementation may be warranted, but needs to be done with consideration based on dietary intake.

Other topics
Two ‘Stop Press’ articles consider:

  • A reminder that Enzira/CSL Biotherapies and Viroflu/Inflexal V influenza vaccines should not be prescribed for children under 5 years because of the risk of febrile convulsions.
  • Advice not to apply aqueous calamine cream onto the skin before an X-ray examination because it may affect the outcome of the radiograph.

All suspected adverse reactions to medicines should be reported via the Yellow Card Scheme

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