Clinical Knowledge Summaries (CKS) has been updated in May 2010 for the following clinical areas:
Action: Clinicians who see patients with any of these conditions may find the new and updated information useful when reviewing current clinical practice.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for May 2010 (PDF).
This issue contains drug safety advice in the following areas:
- Possibility of an increased risk of persistent pulmonary hypertension in the newborn of mothers receiving selective serotonin reuptake inhibitors (SSRIs) and selective noradrenaline reuptake inhibitors (SNRIs) in pregnancy
- Increased risk of bone fractures in patients receiving SSRIs and tricyclic antidepressants (TCAs)
- An interaction between carbapenem antibiotics and valproic acid that results in decreased blood levels of valproic acid
- Reminder to prescribe oral tacrolimus by brand name to avoid medication errors as a result of brand swapping since the brand are not interchangeable
- Warning about the increased risk of myopathy in patients receiving the highest licensed dose of simvastatin (80mg)
Action: Clinicians will find this publication to be a useful review of current issues in drug safety.
The National Institute of Health and Clinical Excellence (NICE) has issued updated information regarding the status of publication of final guidance and consultations on draft guidance during the current political negotiations to establish a government.
NICE has a duty to be politically impartial and in order to not provide topics of inappropriate focus or to distract from important political debate they follow the rules of purdah as advised by the Cabinet Office.
Action: Clinicians will be well aware of the current political negotiations. NICE are expected to publish planned guidance once a government is established.
The National Institute for Health and Clinical Excellence (NICE) has been ordered to reconsider and reissue guidance on the use of strontium ranelate (Protelos®) by the Court of Appeal.
The manufacturer of strontium ranelate successfully argued that NICE failed to provide sufficient reasoning behind the decision to reject post-hoc evidence relating to the efficacy of the drug in reducing hip fractures. NICE must now reconsider the evidence and issue fresh advice within 3 months.
NICE has advised that the recommendations in the osteoporosis - primary prevention and the osteoporosis - secondary prevention guidelines that relate to strontium will be withdrawn pending this review. All of the other recommendations remain in place. Local arrangements will need to made in order to identify when strontium ranelate can be prescribed until the new guidance is published.
Action: Clinicians should be aware of this decision. It may be prudent to continue to follow the previous guidance while the review in finalised.