from the editor

A Happy and Busy New Year!

Dr. FlackBy Sean Flack, MBChB, FCA
SPA News Editor

Happy new year to all fellow SPA members! It’s been a busy year on multiple fronts already and the FDA has been particularly impactful on our specialty. First, they released a safety announcement warning about the use of general anesthetics and sedation drugs in young children and pregnant women: http://www.fda.gov/Drugs/DrugSafety/ucm532356.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
Warning labels on anesthetic and sedation drugs are now required and health care professionals and parents/care-givers are advised to discuss benefits, risks and timing of procedures requiring anesthesia/sedation. SPA has issued a response that is both posted on the society’s website and reproduced in this newsletter.

Shortly after this safety announcement came news of the first-ever FDA-approved therapy for spinal muscular atrophy (SMA), the most common genetic cause of death in infants.  The severity of SMA is correlated with the amount of survival motor neuron (SMN) protein produced and SpinrazaTM (nusinersen) influences gene expression in order to increase production of fully functional SMN protein.

It is expensive (well over $200,000/year for the drug alone) and resource intense (six intrathecal injections in year one, four in year two and two every year thereafter). Early trial (randomized, controlled and open label) results demonstrated clinical efficacy (improvement in motor milestones) and a favorable safety profile which led the FDA to fast its track its approval.

This is huge news for the SMA community and your neurology/rehab medicine colleagues are likely being inundated with calls from families wanting this treatment for their child. As pediatric anesthesiologists, we will have the privilege of helping children receive spinrazaTM and the responsibility of ensuring that the safety profile of this new drug is closely monitored.

For more information, here are some helpful links:

I hope you enjoy the annual reviews from SPA’s 30th annual meeting last October and other content in this newsletter. I look forward to seeing everyone in Austin, TX for Pediatric Anesthesiology 2017!

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