Pradaxa may expire after thirty days

There was important news concerning the short shelf-life of the novel new blood-thinner, dabigatran (Pradaxa) reported today.

Once dispensed, most medicines expire after a year.  Dabigatran, however, is far from the usual pill.  It’s packaged in pellet form within a capsule. These pellets are highly susceptible to water and humidity.  So when dispensed in a typical vial–not a single-sealed blister pack–the drug expires in only 30 days.

Wow, I hadn’t known that. Apparently, neither did the chief investigator of the landmark RE-LY trial, Dr Michael Ezekowitz.

The important issue here is that an expired capsule might have less blood-thinning effect.  That’s pretty important knowledge, especially since most patients and doctors expect pills to last a year.

I am not sure whether blister packs will evolve as standard packaging for Pradaxa or not. Maybe.

Here’s another example of how we learn about new medicines on the go.

Thought Mr Gladwell would likely say not, perhaps our ‘new media’ will spread this important news faster than would have happened in the past.

JMM

Comments

  1. Dave says

    Dr. John my pradaxa leaflet tells of the 30 day warning, they are dispenced in 30 day bottles at 2 pills aday, I guess I dont see the problem unless you dont take your medication like perscribed. If this is the only problem so far with Pradaxa over warfarin then I would do flips of joy, I was told I had to start on thinner and given the choice of warfarin or Pradaxa, after a little reasearch and talking to my mail order script provider from my Insurance company, Pradaxa was a non preferred drug but the cost was $60.00 for a three month supply. I decieded to go with Pradaxa over the warfarin and the blood tests and the trips to get draws for monitoring. In the long run it should be just as cheap or a little more than warfarin. I agree the cost should be lowered, but what I dont understand if you factor in the other costs of using warfarin, which is more expensive.
    Dave

    • says

      Dave,

      You did great with the cost of Pradaxa. Congrats.

      Which of the two drugs is more expensive varies considerably. Arguably, Pradaxa’s overall cost to the healthcare system may be less because the drug’s superior efficacy and safety profile will offset its greater upfront cost. For the individual though, such cost-savings may be harder to realize. For instance, some insurance plans don’t cover drugs as well as office visits (for INR testing). For other plans, it’s the opposite.

      We will see.

      Thanks.