Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

ORACLE Study Statement

The Medicines and Healthcare products Regulatory Agency has issued a statement in response to the publication of the seven-year follow up of the ORACLE study.

The statement has been issued jointly with the Royal College of Paediatrics and Child Health and the Royal College of Obstetricians and Gynaecologists. It states that, "Pregnant women should not be concerned about taking antibiotics to treat infections. Antibiotics save lives, and pregnant women with possible or obvious infections must be considered for treatment with antibiotics".

Action: This statement can be used to reassure patients who may be alarmed by the publication of this study.

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Antibiotics in pregnancy and paracemamol linked to asthma

The Lancet has published two studies this week that have linked the use of certain antibiotics during pregnancy to an increased risk of cerebral palsy and regular use of paracetamol under the age on 1 year with an increased risk of developing asthma. Both of these studies have been reported in the general media (BBC - Antibiotics and Paracetamol).

The first study is a seven-year follow up of the ORACLE study. ORACLE I compared the use of erythromycin and/or co-amoxiclav with that of placebo for women with preterm rupture of the membranes without overt signs of clinical infection. ORACLE II compared the use of erythromycin and/or co-amoxiclav with that of placebo for women in spontaneous preterm labour and intact membranes.

These studies have provided valuable information to ensure that co-amoxiclav is avoided during pregnancy and that erythromycin is only used in early labour when membranes have ruptured. This recent analysis has shown that both of the study antibiotics are linked to an increased risk of cerebral palsy.

Patients may be concerned about using antibiotics during pregnancy in light of this study however these studies specifically looked at early labour without signs of infection. Patients who are taking antibiotics during pregnancy with signs of infection should be advised of the risks of taking antibiotics compared to the risks of an untreated infection.

The second study used data from the International Study of Asthma and Allergies in Childhood (ISAAC) to investigate the association between paracetamol consumption and asthma.

This study included data from over 200,000 children in 31 countries. It found that use of paracetamol for fever in the first year of life was associated with an increased risk of asthma symptoms when aged 6–7 years (Odds Ratio 1.46 [95% CI 1·36–1·56]). This relationship was dose dependent with an OR of 1.61 for "medium use" and 3.23 for "high use".

The authors are keen to stress that these findings "do not constitute a reason to stop using paracetamol in childhood" but that paracetamol should be reserved for children with a high fever (38.5C or above).

Action: Clinicians should be aware of these studies. Patients and parents are likely to be alarmed by these findings and may seek reassurance.

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MeReC Extra 35

The National Prescribing Centre (NPC) has published MeReC Extra 35 (PDF).

This MeReC covers some of key recommendations from the updated NICE guideline on type 2 diabetes. It includes a discussion in the following areas:

  • HbA1c targets
  • Some risks and benefits of intensive glucose lowering therapy
  • Appropriate use of self monitoring of blood glucose
  • Place in therapy for hypoglycaemic agents
  • Interventions should I use to reduce cardiovascular risk

Action: Clinicians involved in the treatment of diabetes will find this MeReC Extra to be useful and informative.

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COPD treatments and risk of death

The Annals of Internal Medicine has published the findings of an observational study that aimed to examine the association between various respiratory medications and risk for death in patients with newly diagnosed chronic obstructive pulmonary disease (COPD).

The study identified 32,130 case patients and matched these to 320,501 control cases. 11,897 records contained cause-of-death data, 2,405 case patients had respiratory deaths and 3,159 case patients had cardiovascular deaths. Records were also assessed for exposure to inhaled corticosteroids, ipratropium, long-acting beta-agonists, and theophylline in the 6 months preceding death.

The odds ratios (OR) for all-cause mortality for each drug were as follows:

  • 0.80 (95% CI, 0.78 to 0.83) for inhaled corticosteroids
  • 1.11 (95% CI, 1.08 to 1.15) for ipratropium
  • 0.92 (95% CI, 0.88 to 0.96) for long-acting beta-agonists
  • 1.05 (95% CI, 0.99 to 1.10) for theophylline

In addition, ipratropium was associated with an increased risk of cardiovascular death (OR, 1.34 [CI, 1.22 to 1.47]) and inhaled corticosteroids were associated with reduced risk for cardiovascular death (OR, 0.80 [CI, 0.72 to 0.88]).

It should be noted that the study did not collect data or correct for smoking status or lung function. The observed differences may be explained by differences in these variables and the authors therefore conclude that, "the possible association between ipratropium and elevated risk for all-cause and cardiovascular death needs further study".

Action: Clinicians should be aware of these findings and the limitations of this analysis. Patients can be reassured that cause and effect has not been demonstrated and that more research is required to investigate these findings. Clinicians should continue to implement the current NICE Guideline.

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MHRA publish SSRI meeting minutes

The Medicines and Healthcare products Regulatory Agency have published the minutes of a meeting held with Bob Fiddaman, campaigner and author of the Seroxat Sufferers blog, to discuss withdrawal issues.

The meeting discussed the current warnings in the patient information leaflet and the problems encountered when ending treatment with selective serotonin reuptake inhibitors (SSRIs), but especially paroxetine (Seroxat®). Attention was also drawn to low levels of awareness of withdrawal as a problem and due to this a lack of expertise and support when patients do encounter withdrawal symptoms, for example by using liquid formulations.

Action: Clinicians should be well aware of the potential for withdrawal symptoms associated with SSRIs, especially paroxetine. Using liquid formulations or changing to longer acting treatments (fluoxetine) towards the end of therapy may make treatment withdrawal easier.

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