Heartfelt with Dr Melissa Walton-ShirleyView all posts »
PPI and clopidogrel warning: FDA, next time, please phone a friendDec 6, 2009 22:48 EST
As predicted, we are already hearing from panicked patients who wonder if they need to stop their proton-pump inhibitor (PPI). I told my nurse practitioner to switch the last patient to an H2 blocker until we could work her in to discuss the issue. Although we might brush this off as an annoying turn of events, it's actually a pretty serious indictment of just how far behind our FDA has become on late-breaking clinical trials. It's not just a serious breach of information gathering on behalf of the administration; it's a complete misrepresentation of the facts and hints that someone might be a bit too lazy to stay on top of the issues.
I walked by a friend in the pressroom at the American Heart Association meeting who motioned for me to stop by his laptop. "What do you think about this?" he asked, turning his screen so I could read the headlines "FDA warns about PPI/clopidogrel interaction." "That issue was resolved weeks ago," I replied. I scanned the "warning" and mumbled, "Way to go, FDA," wondering to myself if anyone there had even heard of the acronym COGENT. (COGENT was presented at the TCT meeting in October 2009 and was a randomized trial of around 3000 patients that demonstrated NO INCREASE in cardiac events with the combination.) Annoyed, I rolled my eyes and walked off.
The central question here is this, "How well-informed is our regulatory administration?" If an entire pressroom of international journalists, most of whom are nonphysicians, are 1000 times more well-informed than our own FDA about this topic, how far off the mark are other government entities on terrorist threats, airline safety, or bridge repair? Sometimes, being "behind the door" when information is passed out is not just annoying or cute, it's downright dangerous. Patients could actually stop their PPI, develop an ulcer and bleed based on this unnecessary warning. So far, there isn't one single death confirmed from a combination of PPI and clopidogrel, but stopping either medication or both could be lethal for some patients.
So what exactly are the issues with our FDA these days? If they have "too few" consultants, they need to hire more. If there were no money to fund the thorough research of a topic, I'd recommend they at least Google it before "warning about" or "black-boxing" anything. I'd at least do a street shout-out, kind of like the Cash Cab contestants do before making a big decision about what to do next.
In my 20 years of private practice, this FDA warning takes the cake. Next time, I'd suggest a thorough perusal of the latest data before making any big decisions. If Google-ing the topic or the street "shout-out" fails, they could always phone a friend…perhaps two friends, a well-informed cardiologist or, I'm ashamed to admit, even better, a busy medical journalist.
See:COGENT: No CV events but significant GI benefits of PPI omeprazole