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

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4th February 2009

The MHRA and CHM have published the February edition of Drug Safety Update. This issue gives drug safety advice on two matters. Firstly, tibolone increases the risk of breast cancer recurrence in women with a history of breast cancer. Secondly, although the absolute risk for ‘healthy’ users is low, all NSAID users appear to be at some increased thrombotic cardiovascular risk.

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 LIBERATE trial was designed to investigate whether tibolone is effective and safe to use in women with a history of breast cancer. The study was stopped early because it identified a significantly increased frequency of breast cancer recurrence in the tibolone group compared with the placebo group. It also confirmed a higher incidence of vaginal bleeding or spotting and increased endometrial thickness in the tibolone group compared with placebo. Tibolone (or conventional HRT) should not be used in women with known or suspected breast cancer, or in those with a history of breast cancer.

Non-steroidal anti-inflammatory drugs (NSAIDs)
Results of two recently published epidemiological studies lend support to the view that some increase in thrombotic cardiovascular risk may apply to all NSAID users, irrespective of their baseline risk. The greatest concern relates to chronic use of high doses (especially for coxibs and diclofenac). The absolute increase in risk for ‘healthy’ users is very low.

The need for long-term treatment should be reviewed periodically. Current advice remains that patients should use the lowest effective dose and the shortest duration of treatment necessary to control symptoms. Overall, evidence continues to indicate that naproxen is associated with a lower thrombotic risk than coxibs. For ibuprofen, no significant increase in risk has been identified for doses of up to 1200 mg daily.

Further information on the cardiovascular risk of NSAIDs is available in MeReC Extra No. 30, which was also summarised in a MeReC Stop Press blog. Additional resources, such as eLearning materials and a patient decision aid, are also available on the musculoskeletal section of NPC. The data focussed commentary contains a summary of the evidence base concerning the risks of NSAIDs and contrasts that evidence with primary care prescribing data for England. Implementation resources are also provided to help healthcare professionals ensure NSAID prescribing is in line with national guidance and facilitate the review of patients taking NSAIDs.

A European assessment has concluded that toremifene is associated with a dose-dependent increase in QT interval, which carries a risk of serious cardiac arrhythmia.

The EMEA has completed a review of the safety of methylphenidate in the treatment of attention-deficit/hyperactivity disorder (ADHD). The Agency’s Committee for Medicinal Products for Human Use has concluded that the benefits of medicines that contain methylphenidate continue to outweigh any risks when used in their licensed indication to treat children aged 6 years or older and adolescents for ADHD. However, the Committee concluded that prescribing information should be made consistent and should be updated with further guidance on pre-treatment screening and continued monitoring of patients. See MeReC Stop Press blog for further details.

Other articles

  • Yellow Card Scheme update: reporting guidance
  • Latest safety information on line
  • Correction: temsirolimus—severe hypersensitivity reactions during infusion
  • Patient Information Leaflet of the month: Actonel once-a-week
  • Consultation: measures to strengthen the medicines’ supply chain

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