NPC Archive Item: New Drug Safety Update from MHRA/CHM (April 2009)

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9th April 2009

The MHRA and CHM have published the April edition of Drug Safety Update. This edition gives drug safety advice on antiepileptics, highlights advice from the CHM on the use of over-the-counter cough and cold medicines in children, and provides a Yellow Card Scheme update on HPV vaccine.

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

The available data suggest that long-term use of carbamazepine, phenytoin, primidone, or sodium valproate is associated with decreased bone mineral density that may lead to osteopenia, osteoporosis, and increased fractures in the following at-risk patients:

  • those who are immobilised for long periods
  • those who have inadequate sun exposure
  • those with inadequate dietary calcium intake.

Vitamin D supplementation should be considered for at-risk patients who are taking these medicines long term.

Over-the-counter cough and cold medicines for children
As we discussed in a recent MeReC Stop Press Blog, cough and cold remedies containing the ingredients listed below should no longer be used in children under 6 years as the balance of benefits and risk has not been shown to be favourable.

  • antitussives: dextromethorphan and pholcodine
  • expectorants: guaifenesin and ipecacuanha
  • nasal decongestants: ephedrine, oxymetazoline, phenylephrine, pseudoephedrine and xylometazoline
  • antihistamines: brompheniramine, chlorphenamine, diphenhydramine, doxylamine, promethazine and triprolidine

Products for children from 6 to 12 years will only be available through pharmacies where advice can be given, although some combinations (e.g. cough suppressants and expectorants) are being phased out. Parents and carers should follow advice to relieve symptoms as outlined in the Department of Health’s 2007 guidance ‘Birth to Five’.

HPV vaccine
The UK immunisation programme against human papillomavirus (HPV) is mainly school-based and targeted at girls aged 12–13 years. Across the UK, at least 700,000 doses have been administered so far. Most of the 1,454 suspected adverse reactions reported to MHRA in association with Cervarix®▼ (HPV vaccine) relate to signs and symptoms of recognised reactions, most commonly dizziness, nausea, headache, pain in extremity (mainly sore arm), and syncope. The number and nature of these suspected adverse reactions is in line with what was expected. The CHM has agreed that no new or serious risks have been identified since Cervarix®▼ has been used in the UK, and that the balance of benefits and risks remains positive. The MHRA and CHM will continue to monitor its safety and any suspected adverse reactions associated with Cervarix®▼ should be reported via the Yellow Card Scheme. Further information on HPV vaccine is available here.

Other articles

  • Off-label use or unlicensed medicines: prescribers’ responsibilities
  • Methylthioninium chloride (methylene blue): update on CNS toxicity with serotonergic drugs
  • Patient Information Leaflet of the month: Proctofoam HC
  • New MHRA webpage resource for pharmacists

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