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Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Drug Safety Update - January 2012

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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2 Comments to “Drug Safety Update - January 2012”

  1. [...] January, the Drug Safety Update reminded clinicians of the clinically important increases in heart rate and blood pressure seen in [...]

    Pingback by Prescribing Advice for GPs » New atomoxetine safety recommendations — May 31, 2012 #

  2. I current times, the Drug Safety issue is becoming more and more alarming. Medicines have become such that if you try to control blood pressure, you can loose control over you heart rate. Every medicine has one or another component that gives such a side effect and In spite of knowing it, you are compelled to use it as we are not left with other options. The risk appears to be huge in patients who are already in risk of developing another conditions.

    FDA and other Government Agencies are trying to control this situation, however, they seem to be failing. There are many reason behind it. The basic reason is the health system in which we are living. Every part of the system has its own interest. Pharmacy manufacturers, Doctors, Hospitals, Laboratories, and other related institutions are all involved in this circle.

    The basic need of an hour is to reform the Health System. Each and every interest has to be reformed from ground level.

    It may take time. but It is possible. Someone has to start.

    Comment by Andy King — January 16, 2012 #

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