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Wednesday, February 13, 2013

Pradaxa (dabigatran) degrades on removal from original packaging; do not place in a pill organizer.

Formerly Pradax in Canada, the name is now Pradaxa in both Canada and the U.S.

Note: The following is an UPDATE to a blog originally posted in early 2013. The views are of a patient taking Pradaxa and are NOT the views of a medical expert.
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If you take Pradaxa (dabigatran) rather than coumadin, you must be aware of the following taken from the Pharmacist's Letter of October 2016:

Pradaxa must be protected from moisture.
All capsules must be used within four months of opening the original container.
Pradaxa must be dispensed in the original container. The bottle has a desiccant in lid.

Now, you know the core concerns. Please, read on.
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I started taking Pradaxa, originally called Pradax in Canada and Pradaxa in the States, more than four years ago. So, I am not addressing a new problem. And yet, this serious problem is still with us. Contrary to an FDA warning, some pharmacists are continuing to dispense Pradaxa capsules repackaged in standard pharmacy vials.

Why is this a problem? According to Boehringer Ingelheim, Canada, "Pradaxa is very sensitive to moisture in the air." For this reason, the drugmaker recommends keeping Pradaxa in its original foil blister pack or in its original special bottle with a drying agent in the lid. The company warns, "Do not put the capsules in pill boxes or pill organizers . . . " The FDA also adds a warning about storing the drug in areas which are subject to temperature extemes, either hot or cold.

Pradaxa is an anticoagulant replacement for Coumadin (warfarin). Both drugs are taken by those in danger of suffering a stroke. Compared to aspiring, Pradaxa poses less danger of causing serious intracranial bleeding. After an MRI, I was diagnosed with micro-bleeding in the brain. I also suffer from TIAs or small strokes. Small strokes can lead to large strokes if an anticoagulant is not taken regularly. I take Pradaxa twice a day.

Without my anti-clotting medication I have a six percent chance of suffering a serious stroke in any given year. That's six strokes in a hundred at risk patients. One of the six will die and the other five will suffer strokes causing differing degrees of debilitation. Strokes are the fourth leading cause of death in the U.S.

If you take Pradaxa, check your prescription bottle. My last one was a palm-and-turn plastic bottle with a lid riddled with holes. Pradaxa is only good for four months after its original bottle with the special desiccant-containing lid has been opened.

How long my three month supply of Pradaxa, dispensed in a bottle with holes in the lid, retained its potency is anyone's guess. There is no question the last capsules would be markedly degraded. That much is certain.

Atrial fibrillation (AF) affects a great many people and according to the Mayo Clinic is increasingly common in seniors. AF is a type of irregular, often rapid, heartbeat that can lead to the formation of blood clots in the heart. These clots can migrate to the brain where they cause a cerebral infarction, a cerebrovascular incident — a stroke in simple terms.

My heart is in constant atrial flutter, similar to, but not quite the same as, atrial fibrillation. My daily low-dose Aspirin is not strong enough to protect me from the increased threat of stroke. My doctors discussed my situation and settled on Pradaxa 110mg as the best option. Pradaxa also comes in two other strengths: 75mg and 150 mg.

Black marker dates Pradaxa still in foil.
Transferring Pradaxa to a pill organizer is a common mistake. Lots of people do it. There is an "Important" instruction on the side of the box but it is at the bottom of a list and in the same type style as the other notes. For a truly important instruction, it does not jump off the package as one might expect it would.

I confess, when I first started taking Pradaxa I missed the warning. I'm an old geezer. My making a mistake is not surprising. It is to be expected. But clearly my pharmacist has also missed the warning. How common is the mistake? Like so many today, pharmacists are overworked. The staffing at my drugstore has been cut and this, I believe, can lead to errors.

I have now had Pradaxa dispensed in both the original bottle and the blister packs. I prefer the blister pack. I'm old. My memory is not good. Unable to continue using a weekly organizer for my Pradaxa, I take a Sharpie permanent marker and write the day and time of day, AM or PM, that each pill must be taken on the blister pack itself.

I believe this is very important. Pradaxa has an extremely short half-life. The concentration in your body drops drastically in just 24 hours. For this reason taking a dose quite late, or completely forgetting a capsule, increases the risk of stroke.

I find it strange that if grapefruit should not be consumed while taking a drug my pharmacist has a sticker for this. The sticker is slapped on the pill bottle at the time the prescription is filled. Pradaxa needs a similar day-glow sticker to warn folk not to expose the capsules to air, to keep the medication in its original container until it is taken.

If a druggist dispenses Pradaxa in anything other than the original packaging, one pharmacist told me the capsules should be immediately returned to the drugstore to be safely discarded. The pharmacist should replace those capsules with new as it is difficult to know how much humidity such capsules have encountered. Were they kept in a bathroom with a steamy shower, or stored in a kitchen near pots of boiling water? The druggist told me not to take a chance. Return the capsules.

One last thing about Pradaxa. There is now a reversal agent available. In an emergency situation where there is a need to reverse Pradaxa’s blood-thinning effect, Praxbind (idarucizumab) is now available. I personally know how important this can be. I had to have emergency bowel surgery a little more than 12 hours after taking my last dose of Pradaxa.

For more info on Pradaxa, check out the Pradaxa website or follow this link to a story in The Globe and Mail: Questions raised about new class of blood thinners.

Read the Globe story and you will realize that Pradaxa has had mixed reviews, especially in the media. A word to the wise, don't rely too heavily on media reports when it comes to medicine. Yes, Pradaxa is a dangerous new drug, but then weakening the blood's ability to clot is clearly a dangerous practice. Warfarin, formerly the drug of choice, is also a dangerous drug.

As I said earlier, I was once on warfarin. I had to have my blood regularly tested to be certain I was getting the maximum benefit from the drug. Warfarin, in some people, can be notoriously difficult to regulate.

It must be noted that the maker of Pradaxa has claimed no regular blood testing was required with the new anticoagulant. MedPage Today and others are reporting that monitoring drug plasma levels could improve the safety of Pradaxa. I have had my blood tested twice and so far Pradaxa is working as promised.

According to the Mayo Clinic, warfarin reduces the risk of stroke by about 64 percent. Unfortunately, ". . . only 50% of patients with atrial fibrillation who would benefit from warfarin therapy receive it, and the discontinuation rates are high. At 1 year, more than 25% of patients stop warfarin . . . " For these reasons, drugs like Pradaxa are very attractive.

My doctors believed Pradaxa to be better at stroke prevention than warfarin and with a lessened chance of major bleeding. Some time ago, I had an MRI that revealed micro-bleeding in my brain. Not enough is known about micro-bleeding for my doctors to feel confident putting me on warfarin. The rate of intracranial bleeding with Pradaxa has been shown to be less than that of warfarin. To lessen my risk of suffering a major bleeding event in my brain, and after consulting with the neurology department, my doctors decided the best alternative for me was Pradaxa110 mg taken twice daily. I continue to take an aspirin daily, the 81mg kind.

There's a lot of which to be aware when taking a drug like Pradaxa. Read the warnings that come with all your meds carefully. Check out the Pradaxa info online. Click on the links that I have supplied. If your doctor advises a drug like Pradaxa don't be too quick to dismiss the suggestion. Doctors go with the best odds. I liked one comment made on another site discussing Pradaxa: "You can transfuse blood, but you can't transfuse brain".

Lastly, here are a couple of websites you might find interesting. The first is a website run by the Harvard Medical School. The article is titled: Is the alternative to warfarin safe and effective? The second is a site dedicated to AF: StopAfib.

Good luck with your meds.

And if you are interested in knowing more about my emergency operation, done before the release of the reversal agent Praxbind, here is a link: 16 hours in the ER; 16 hours well spent.

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