NPC Archive Item: June Drug Safety Update from MHRA/CHM

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11th June 2009

The MHRA and CHM have published the June edition of Drug Safety Update. This issue gives drug safety advice on several issues: the risk of venous thromboembolic events with antipsychotics, a recommendation that chloral hydrate should not be first-line for insomnia, and reminders that oral salicylate gels should no longer be used in children younger than age 16 years, and that topical ketoprofen carries a risk of photosensitivity reactions.

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

Antipsychotic use may be associated with an increased risk of venous thromboembolism (VTE). This was the conclusion from an MHRA public assessment report which considered UK Yellow Card data and worldwide published epidemiological studies on antipsychotics and VTE. Currently, there are insufficient data available to determine any difference in risk between atypical and conventional antipsychotics, or between individual drugs. The MHRA advises that all possible risk factors for VTE should be identified before and during antipsychotic treatment and preventive measures undertaken.

Chloral hydrate (Welldorm®) and Triclofos
These products are not first-line options for insomnia. They are indicated only for the short-term treatment of severe insomnia which is interfering with normal daily life and where other therapies have failed, as an adjunct to non-pharmacological therapies. The use of hypnotics in children and adolescents is not generally recommended, and if used should be under the supervision of a specialist. Welldorm elixir can be used in children aged two years or older as an adjunct to behavioural therapy and sleep-hygiene management, usually for less than two weeks.

Oral salicylate gels
As we have previously blogged, the MHRA has reviewed the safety of oral topical salicylate-containing products after publication of a case report of suspected Reye’s syndrome associated with use of a dental gel that contained choline salicylate in a 20-month-old child. They have since concluded that the clinical features in this patient were more consistent with salicylate toxicity than with Reye’s syndrome. The CHM acknowledges that although there is only a theoretical risk of Reye’s syndrome, these products should be contraindicated in those younger than age 16 years in line with other oral salicylate containing preparations.

The MHRA advises that there are several dental gels available which contain a local anaesthetic/mild antiseptic, rather than a salicylate. For infant teething, gentle pressure with something cool such as a chilled teething ring may help relieve teething pain. For pain associated with orthodontic devices, salt water mouthwashes are recommended for sore areas. For discomfort arising from tooth movement, a paracetamol-based painkiller is recommended. More information on this issue can be found in the MHRA press release.

Topical ketoprofen
Topical ketoprofen causes photosensitivity reactions. Healthcare professionals, particularly pharmacists, are reminded to advise users to avoid direct sunlight, ultraviolet (UV) rays, sunlamps, and sunbeds while using topical ketoprofen, and to exercise caution for two weeks after stopping treatment. If users experience a skin reaction to sunlight, sunlamps, or sunbeds they should stop using ketoprofen gel and see a healthcare professional or go to hospital.

Clopidogrel and proton pump inhibitors (PPIs): As we have previously blogged, the EU Committee for Medicinal products for Human Use has reviewed the available evidence for an interaction between clopidogrel and PPIs. They conclude that the data support a clinically significant interaction that makes clopidogrel less effective when given with these medicines.

The MHRA recommends that the need for PPI therapy in patients who are also taking clopidogrel should be reviewed at their next appointment and these medicines should only be used concomitantly when essential. PPIs should be prescribed strictly in line with their licensed indications and health care professionals should check that patients who are taking clopidogrel are not buying over-the counter omeprazole. Further information will be provided in the next issue of DSU.

Erlotinib (Tarceva▼): new safety information is now available regarding the risks of gastro-intestinal perforation, bullous and exfoliative skin disorders, and ocular disorders with this drug.

Counterfeit insulin pen Novofine needles: vigilance is needed for lot number 08J02S.

Prescription of blood lancet devices: there is a risk of hepatitis with incorrect use.

Other articles

  • Yellow Card Scheme update: The Black Triangle Scheme▼
  • Hot topic – counterfeit medicines: patient guidance for distribution via pharmacies
  • Patient Information Leaflet of the month: Skelid® (tiludronic acid) for Paget’s disease
  • Medical devices: practice guidance

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