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The Drug Safety Update is an NHS Evidence accredited provider
23 January 2012
The MHRA and CHM have published the January edition of Drug Safety Update (DSU). This edition includes drug safety advice on atomoxetine▼ and statins:
- Atomoxetine can cause increases in blood pressure and heart rate. New contraindications, warnings and monitoring advice have been issued.
- Statin use may be associated with a slight increase in the risk of hyperglycaemia and diabetes. However, the benefits of statin treatment strongly outweigh any risks.
See below for more information on these issues. DSU also contains a reminder regarding the potential risk of hypersensitivity with chlorhexidine and details on how to comment on the Public Consultation on new pharmacovigilance legislation.
Atomoxetine
Atomoxetine is used in the treatment of patients with attention-deficit/hyperactivity disorder (ADHD). A review of clinical trial data has shown that it can cause clinically important increases in blood pressure or heart rate, or both, in a small proportion of patients. Atomoxetine should not be used in patients with severe cardiovascular or cerebrovascular disorders. Thorough pretreatment screening and regular monitoring of cardiovascular status is recommended. Specialist cardiac evaluation and advice should be sought if pretreatment findings suggest cardiac disease or history, or if symptoms suggesting cardiac disease are found during treatment.
More information on the new contraindications, warnings and monitoring advice can be found in DSU, the Summary of Product Characteristics for atomoxetine (updated sections) and the letter for healthcare professionals. A physician’s guide for assessing and monitoring cardiovascular risk has also been produced, which contains a checklist of actions which should be taken before prescribing or dispensing atomoxetine. Suspected adverse reactions to atomoxetine should be reported via the Yellow Card Scheme.
Information on managing ADHD can be found in NICE guidance on the diagnosis and management of ADHD in children, young people and adults and on NHS Evidence.
Statins
In 2010, a meta-analysis reported that statin therapy was associated with a slightly increased risk of new onset diabetes (see MeReC Rapid Review No. 1098). DSU advises that there is sufficient evidence to support an association between statin use and new onset diabetes. However, the overall benefits of statins strongly outweigh any risks, including in those at risk of developing diabetes or those with pre-existing diabetes. The increased risk of diabetes is therefore not a reason for discontinuing statin treatment.
The risk appears to be mainly in patients already at increased risk of developing diabetes. Raised fasting blood glucose at baseline is a key risk factor. Other risk factors include history of hypertension, raised triglycerides, and raised body mass index at baseline. Patients at risk should be monitored both clinically and biochemically according to national guidelines. (See NICE guidance on lipid modification and NICE guidance on type 2 diabetes).
The level of risk of new onset diabetes may vary between statins. However, there is insufficient evidence to confirm or exclude an increased risk for any member of the statin class.
See DSU for a summary of the evidence and its limitations. Further information on lipid modification can be found in the NICE guidance on lipid modification and NICE guidance on type 2 diabetes, the NPC elearning materials on lipids, and on NHS Evidence.
Please comment on this rapid review using our feedback form.
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