The blood-thinning drug Pradaxa made headlines Thursday when a New York Times article by Katie Thomas blew the lid off insider communications. The scandal hit the fan because a federal judge in Illinois released drug company documents revealing that the manufacturer knew about Pradaxa complications, but went out of its way keep them under wraps.
The bottom line: Pradaxa can cause life-threatening hemorrhages if the dose isn’t spot on. It’s not always easy to tell when the dose is correct. As a result, doctors are often flying blind.
Visitors to our website have been asking about the safety of this drug for years. Here are just a few of the questions we have received:
Q. I have recently been diagnosed with Stage III Kidney Disease by a nephrologist. I also have A-Fib [atrial fibrillation] diagnosed by my cardiologist.
My problem is that the cardiologist suggested I take magnesium to help with sleep and my heart. I am reading in your Guide to Home and Herbal Remedies that too much magnesium could cause further damage to my kidneys.
I take Pradaxa (75 mg) twice a day along with propafenone for my heart, valsartan, Estrace and hydrochlorothiazide.
Is there anything else I need to do to keep my kidney disease from getting worse? Otherwise I am in good health.
A. Gayle, although you are taking a reduced dose of Pradaxa (which is appropriate for patients with kidney disease), there is the potential for overdose. Older people often have reduced kidney function and you clearly do. That is why you are walking a tightrope when it comes to dosing. If Pradaxa [dabigatran] builds up in your system you could be at serious risk for bleeding. Symptoms to be especially alert to include:
SYMPTOMS OF BLEEDING
- Unusual bruising (bruises that show up without any obvious cause)
- Nose bleeds
- Bleeding from gums that is worse than usual
- Bleeding from a cut that will not stop within a reasonable amount of time
- Urine that has a pinkish or brownish color
- Stools that look red, black or tarry
- Coughing that brings up pink flecks of blood
- Vomiting blood or vomiting anything that looks like coffee grounds
- Headaches, dizziness, weakness
- Unusual joint pain, swelling or discomfort in a joint
Such symptoms are extremely serious and require immediate medical attention.
One final note, Gayle, magnesium can be dangerous if you have kidney disease. Please discuss this with your nephrologist.
Q. I just got back from Ohio helping my Mom who was suffering serious fatigue. She ended up in the hospital from internal bleeding due to an interaction of Celebrex and Pradaxa.
Five different doctors did not mention this combination could be a problem. Why do doctors not have more info about drug interactions?
A. Pat, your mom was lucky she survived her internal bleeding episode. Her doctors should have warned her that taking a drug like Celebrex that can irritate the digestive tract and cause ulcers is quite dangerous in combination with an anti-coagulant like Pradaxa. If an ulcer does occur, it can lead to internal bleeding. Whenever this happens, it is a life-threatening situation. Doctors should be well informed about such interactions and always warn patients what to watch out for. The pharmacist should have caught this potential problem as well.
Q. I was diagnosed with A-fib several months ago. I went to my primary care physician first and he prescribed digoxin for the A-fib and nattokinase for stroke prevention. He then referred me to a cardiologist, who kept me on digoxin but prescribed Pradaxa for stroke prevention.
I have two concerns. One is that every time I watch television for more than an hour, I’m being urged to call an attorney and sue Pradaxa because of possible deadly side effects. The other is cost: Pradaxa is $225.00 a month and my insurance doesn’t cover it. So I’m concerned about both safety and cost.
Is Coumadin [warfarin] a better and much less expensive way to go? How much blood work is required if I take Coumadin? Is there anything else out there that will prevent clots but doesn’t cost so much?
A. You have asked a complex and intriguing question, Bob. Doctors used to primarily rely on warfarin (Coumadin) to prevent blood clots from forming and triggering strokes. Then along came Pradaxa.
One of the big selling points for the new anticoagulant was that unlike warfarin, it did not require frequent blood tests. This “benefit” led doctors to prescribe Pradaxa to over 800,000 patients. Last year alone, Pradaxa earned more than $800,000,000.
But here’s the rub. By monitoring warfarin levels, doctors can adjust the dose to try to avoid under-treatment that might lead to blood clots and strokes or over-treatment that might lead to fatal bleeding episodes. Without a similar test to monitor Pradaxa effectiveness, it is more challenging for physicians to hit the sweet spot. It is estimated that there have been more than 1,000 deaths linked to Pradaxa.
The current scandal surrounding the drug is all about internal documents at Boehringer Ingelheim (the manufacturer of Pradaxa). A researcher at the company seemingly suggested that careful blood monitoring would allow physicians to adjust the dose of Pradaxa so it could prevent strokes without leading to hemorrhage. But this would have upset the marketing advantage over warfarin or other new anticoagulants. In other words, Pradaxa wasn’t supposed to need testing. That was its big selling point.
The unanswered question is whether marketing trumped patient safety. That is the crux of the thousands of lawsuits that are now pending. Did the drug company reveal the complexity and dangers of taking Pradaxa?
We’re not lawyers, so we will not dabble our toes in that water. But we would like to hear about your experience with Pradaxa or other anticoagulants. Share your story below in the comment section.
SIDE EFFECTS OF PRADAXA & COMPLICATIONS
- Bleeding, hemorrhage
- Heartburn, reflux, indigestion, digestive distress, abdominal discomfort, gastritis
- Rash, itching, allergic reactions, anaphylaxis
- Blood disorders
A WORD OF CAUTION ABOUT STOPPING PRADAXA
- Never stop Pradaxa without medical supervision!
- Never stop Pradaxa suddenly. Doing so can trigger a rebound hypercoagulable state that could lead to blood clots and an increased risk of stroke
- If Pradaxa must be stopped for a reason other than life-threatening hemorrhage, a physician will need to substitute another anticoagulant and make the hand off cautiously to prevent either bleeding or blood clots from forming
Again, please share your own story with Pradaxa or any other anticoagulant so that others can benefit from your experience.