Hard calls to make
Ummm…. Hi, Hon. It’s me. Uh, I don’t want you to worry or anything, but I’m calling you from the ER…
And the conversation went pretty much downhill from there.
Now imagine making thirty calls like that. That was my day yesterday, after the FDA announced an ongoing safety review of the type 2 med Actos.
Actos is a member of the TZD family, anti-insulin-resistance drugs that are designed to allow the body to more efficiently use its own insulin to control blood sugar. The other member of the TZD family was Avandia, now effectively banned worldwide. Avandia was actually a great diabetes drug. It did an awesome job controlling blood sugar. The only problem was that whole nasty side effect that it might maybe give you a heart attack.
Actos is under fire for a different reason, for might maybe increasing the risk of bladder cancer. The evidence isn’t 100% clear, but strong enough for France to yank if from the market, and strong enough for Germany to ban new prescriptions.
Here in the U.S., where it’s nearly impossible to get FDA approval of a new med, it’s equally impossible to get rid of one once it’s approved. The FDA is at the five-year point in a ten-year looksee at Actos. At this point the FDA says overall risk of bladder cancer for folks who use the med isn’t higher, but an increase in bladder cancer was noted “among patients with the longest exposure” and in those “exposed to the highest cumulative dose.”
So…. We just need to wait a little longer for everyone on Actos to get cancer, is that it?
Anyway, the five-year data, and a French study, are strong enough for the FDA to change the infamous “Warnings and Precautions” section of Actos’ label. The exact wording isn’t published yet, but the lead sentence of the safety announcement gives us a pretty good clue: “Use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer.”
I guess the new Actos ads will tell us, “call your doctor if you experience bladder cancer.”
The FDA also cautions docs not to use Actos in patients with active bladder cancer, past bladder cancer, or in persons with a family history of bladder cancer.
I predict a free-fall drop of Takeda stock.
“What do you think?” one of our Docs asked me in the hallway.
I’m soooooooooooooo done with these TZDs, I told him. I think we should just pull all our patient’s off of them. It’s not like we don’t have an entire medicine chest of other options. Why wait for trouble to be official?
“Do it,” I was told.
So began to make my phone calls. Yeah, hi, how are you today? Yep. Uh-huh. Uh-huh. Say, are you still taking your Actos? Yeah? Well, OK, I want you to stop…
I started with my most-excitable patients first. I knew by the time I called the third person, the first person would be calling all her diabetic relatives. I wanted the ones most prone to panic to hear it from me first. In terms of speed, social media on the internet is nothing compared to little ol’ ladies with landline phones in small towns. We call it the Viejita-Net.
I told them what was up. Not to panic. That we were being overly cautious. That the drug would linger in their systems for a week or so, and then their blood sugars would begin to climb. I reminded them that short term, higher blood sugar wouldn’t harm them. I asked them to test their blood sugars intensively for a week after that, then come see me.
The plan is to choose successor therapies based on each person’s Actos-free blood sugar patterns. Some will get DDP-4 inhibitors. Some will get basal insulin. If you’d asked me on Monday, I would’ve leaned towards using Victoza for many of them, but just a few days ago a much stronger thyroid cancer and pancreatitis warning was issued by the FDA about that drug too.
I let the front desk know what was going on, and why I’d be transferring so many patients up to them to make appointments. “Wait a minute,” asked the medical records clerk, “Isn’t that the drug we moved all the people who used to take Avandia to?”
Yeah. Yeah, it sure is.
At least at the ER they gave me a heated blanket and a heated pillow.