The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for January 2012 (PDF).
This issue contains drug safety information regarding clinically important increases in blood pressure and/or heart rate caused by atomoxetine (Strattera®). A recent review of clinical trial data found that in general the increases in blood pressure and heart rate were as expected (< 5 mmHg and < 10 bpm) but in between 6% and 12% of patients the increases were much higher (≥ 15–20 mmHg) or heart rate (≥ 20 bpm). Clinicians are reminded that atomoxetine is contraindicated in severe cardiovascular or cerebrovascular disorders and that pre-treatment screening and regular monitoring of cardiovascular status is recommended.
This section also advises clinicians that statins may be associated with an increased risk of hyperglycaemia and diabetes. The risk appears to be greatest in patients who are already at an increased risk of developing diabetes based on raised fasting blood glucose levels. Other risk factors include hypertension, elevated triglycerides and raised body mass index. Overall, the benefits of statins strongly outweigh any risks, even in this population subgroup.
The stop press section reminds clinicians that chlorhexidine is known to induce hypersensitivity, including generalised allergic reactions and anaphylactic shock. Although this effect is very rare, chlorhexidine is widely used in antiseptic products including some that can be purchased.
Action: Clinicians will find this publication to be a useful review of current issues in drug safety.
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