Now that my CAR-T procedure is well behind me, and the window of worst worry is closed, let's talk a little bit about that.
As I may have mentioned, when I was learning about the benefits and risks of Carvykti (my particular CAR-T product), a few of the more prominent conditions being monitored most closely were (in lay terms): headache, spiking fever, immune system overreaction and seizures. That last one (officially Immune Effector Cell-Associated Neurotoxicity Syndrome - ICANS) admittedly sounded kinda concerning. Not enough to pass on the procedure, but one which seemed among the more difficult to anticipate and imagine managing. The warning was not that I would go full grand mal seizure out of the blue, but that I might experience confusion, disorientation, difficulty speaking, reading or writing. Any of the aforementioned would have dissipated after a short amount of time. Fortunately for me (and many others), none of these occurred at all - not even the slightest indication. But here’s the cool part.
Among the collection of post-procedure precaution warnings (included in the lengthy listing of a litany of Important Safety Information (ISI) - as determined by the FDA for approval of using Carvykti), I was not allowed to drive for eight weeks after the infusion (for fear of possibly having a seizure while “operating heavy machinery” ie: driving a car). However, about two weeks before I had my Carvykti infusion, the FDA ruled to change the driving restriction from eight weeks down to two weeks!
This was particularly significant not because of my resulting personal convenience (I work from home so I wasn't really planning to drive anywhere anyway), but was noteworthy because of what it meant scientifically. For the roughly three years that Carvykti has been approved and in use, an overwhelming collection of empirical evidence was amassed and presented to the FDA - allowing them to re-evaluate and then drastically reduce the “driving” caution. By the time I was discharged from the hospital (all part of the preemptive 7-days post-procedure monitoring period; which I completed without any adverse effects at all), I could almost have driven myself home (which I did not!).
The point of all this is that medical science is constantly collecting qualitative and quantitative data about approved drugs and their side effects. When things get worse, warnings are increased. But, if things get better (proven to be less problematic) those changes are noted, and when appropriate the cautions are reduced - always with an eye on safety for the patient and the public.
OBTW: I consented to allow the results from my Carvykti experience to be collected and added to the ongoing patient database of real-world reactions.
