A new class of antihypertensive looks set to become available later this year according to PharmaTimes. A licence application has been filed for approval for Aliskiren (Rasilez®), which is a direct renin inhibitor, with the European Medicines Agency.
The data currently show effective blood pressure lowering, both alone and with in combination with other antihypertensives. The drug has also been well tolerated in the trials compared to placebo.
At launch the drug will be a black triangle drug, safety will need continued assessment during the early years of use. Aliskiren's place in therapy will also need to be evaluated based on relative efficacy and cost compared to existing treatments.
Action: A new class of antihypertensive is a welcome addition but initial use, once it is available, should be cautious.
The European Medicines Agency (EMEA) has announced that it is to update the review of Non Steroidal Anti-Inflammatory Drugs (NSAIDs). The original review was published in October 2005.
The Medicines and Healthcare products Regulatory Agency (MHRA) has released a Question and Answer document in conjunction with this announcement.
Action: All NSAID use carries risk, implementing current recommendations ensures this risk is minimised.
The Health Protection Agency has published a Frequently Asked Questions document that aims to address some of the common issues encountered by healthcare professionals since the introduction of pneumococcal conjugate vaccine (PCV) into the childhood vaccination schedule.
The document answers many questions including:
- What to do if Pneumococcal Polysaccharide Vaccine (PPV) is given in error in place of PCV
- Which vaccinations can be safely co-administered
- How to transition children onto the new schedule when they have part completed the old schedule
Action: This document may prove to be a useful resource when more complicated questions arise in practice.
The Food and Drugs Administration (FDA) has updated the labelling of the norelgestromin-ethinylestradiol contraceptive patch (Evra®) to warn patients and clinicians about the risk of venous thromboembolism (VTE).
Two epidemiological studies have examined the rates of VTE is users of the patch compared to users of oral contraceptives. One study found that rates of VTE were similar while the other study founds that rates of VTE were doubled. The FDA update carries a specific warning that patients using the patch are exposed to 60% more oestrogen despite maximum blood levels being 25% lower than equivalent oral contraceptives.
The patch available on the UK market appears to contain slightly lower levels of oestrogen however it is already recommended in the Summary of Product Characteristics that the patch is not used in patients with a history of venous thrombosis. Additionally, the Scottish Medicines Consortium has recommended that use of this patch is restricted to patients who have demonstrated, or are likely to demonstrate, poor compliance with combined oral contraceptives.
Action: Patients who may benefit from this patch due to poor compliance should be assessed for VTE risk before treatment is started.
Duloxetine (Cymbalta®) has been granted a licence extension to include diabetic peripheral neuropathic pain in adults.
The Scottish Medicines Consortium have reviewed the use of duloxetine for this condition and recommended that use is restricted. They have recommended that treatment is initiated by prescribers who are experienced in the management of diabetic peripheral neuropathic pain as a second or third line therapy option.
Action: Duloxetine is not a first line treatment and may only be appropriate for initiation in secondary care settings.