FDA Orders Safety Review of Pradaxa

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FDA Orders Safety Review of Pradaxa

Postby Cece » Wed Dec 07, 2011 4:18 pm

http://www.medpagetoday.com/Cardiology/ ... aking-news

WASHINGTON -- The FDA said it will begin a safety review of reports of excess bleeding associated with dabigatran (Pradaxa), an oral direct thrombin inhibitor that is approved for prevention of stroke in patients with nonvalvular atrial fibrillation.

The FDA's announcement comes a month after post-marketed reports of about 50 cases of fatal bleeding worldwide surfaced.

The FDA said it wants to determine whether the reports of bleeding are occurring more commonly than would be expected.

In the RE-LY clinical trial, which compared two doses of dabigatran (150 mg bid and 110 mg bid) with warfarin in more than 18,000 patients, the bleeding rates between the two arms were similar.

When the FDA approved the drug in October 2010, it limited its approval to two doses: 150 mg bid and 75 mg bid, a decision that was immediately questioned because the 75 mg dose had never been tested in a clinical trial. Last spring, the New England Journal of Medicine published a commentary in which two FDA researchers involved in the approval decision explained the agency's reasoning, acknowledging a prevailing concern about the potential for excess bleeding.

When the bleeding reports surfaced last month, a spokesperson for drug-maker Boehringer Ingelheim said dabigatran's safety profile was in line with that seen during the clinical trial.

In the meantime, the FDA said that at this time it "believes that Pradaxa provides an important health benefit when used as directed and recommends that healthcare professionals who prescribe Pradaxa follow the recommendations in the approved drug label." The agency advised patients to keep taking the drug and to consult their physicians if necessary.

When Pradaxa is prescribed after CCSVI treatment, is it commonly prescribed at the 150 mg dose or the 75 mg dose?
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Re: FDA Orders Safety Review of Pradaxa

Postby CureOrBust » Thu Dec 08, 2011 1:57 am

My tablets used after I arrived back in Australia were 110mg. However, Dr Sclafani's first choice was an injectible.
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Re: FDA Orders Safety Review of Pradaxa

Postby munchkin » Thu Dec 08, 2011 8:08 am

My tablets are 150 mg. I am taking anti-coagulants longer term so I switched to Pradaxa. Dr. S prescribed Arixtra originally. Cogfog moment.
Last edited by munchkin on Thu Dec 08, 2011 9:38 am, edited 2 times in total.
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Re: FDA Orders Safety Review of Pradaxa

Postby Cece » Thu Dec 08, 2011 8:37 am

Ok, so that is the higher dosage. In July, Dr. Sclafani prescribed Arixtra, an injectable, for me, but that was right around the time that Pradaxa was emerging as the apparent anticoagulant-of-choice after CCSVI treatment. I have agreed with the importance of anticoagulation, and not an antiplatelet like Plavix or aspirin, since at least the summer of 2010, since that was one of the factors that deterred me from going with Dr. Siskin at that time.

If Pradaxa's bleeding complication is similiar to warfarin's, as seen in the Rely trial, is warfarin's complication rate higher than Arixtra or Lovenox's?

I remember Dr. Diana referring to the venous congestion in the eye as a stroke waiting to happen. I am not entirely sure what that meant, and I may have gotten it wrong exactly what she was referring to. This was in one of her presentation videos. If our blood-brain barrier has been weakened by the long-term effects of turbulent flow, could we be more susceptible to bleeding complications than a healthy control? There have been many thousands of CCSVI patients treated and two anticoagulant bleeding-related fatalities. What would be the expected percentage?
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Re: FDA Orders Safety Review of Pradaxa

Postby munchkin » Thu Dec 08, 2011 8:42 am

:oops:
Last edited by munchkin on Thu Dec 08, 2011 9:39 am, edited 1 time in total.
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People are different

Postby MarkW » Thu Dec 08, 2011 9:24 am

Comparing drugs and dosage post CCSVI is dangerous because we are all different (pwMS are more different than the average). My advice is simple:
1-Give your interventionalist a personal and family history for CV matters.
2-Get a test for clotting/thrombosis risk if needed (higher risk people) before CCSVI.
3-Follow your doctor's instruction on post CCSVI medication.
You all should know about Vit D3 and Omega 3 as part of your vein health regime.

Years ago when I worked in a hospital pharmacy, everyone on Warfarin had to have their clotting time tested and warfarin dose adjusted. To help patients (getting testing is time consuming) the newer drugs have tried to reduce/remove the need or testing. However people are different and adjusting dosage by body size does not appear to have worked for everyone on Pradaxa.

Please do expect to be on the same ant-coagulatant/anti-platelet regime as the next person after your procedure for CCSVI syndrome.

MarkW
Mark Walker - Oxfordshire, England. Registered Pharmacist (UK). 11 years of study around MS.
Mark's CCSVI Report 7-Mar-11:
http://www.telegraph.co.uk/health/8359854/MS-experts-in-Britain-have-to-open-their-minds.html
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Re: People are different

Postby CureOrBust » Fri Dec 09, 2011 12:52 am

MarkW wrote:Comparing drugs and dosage post CCSVI is dangerous because we are all different (pwMS are more different than the average)
I also think you may be limited by what is available in four country (re pradaxa dosage)
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Re: FDA Orders Safety Review of Pradaxa

Postby Cece » Fri Dec 09, 2011 7:18 am

It's interesting that the 75 mg dose exists. If that dosage hasn't been tested, who knows how well it works at that dosage? MarkW knows what he's talking about, and I agree with his 1, 2, 3. I would also pay close attention to any warning signs that the drug may be causing bleeding. Let's see....
•Let your healthcare provider know if you develop any signs of bleeding, such as:

◦Easy bruising
◦Cuts or scrapes that are slow to stop bleeding
◦Black, tarry stools; bright-red blood in the stool; or vomiting of blood (signs of gastrointestinal bleeding)
◦Signs of bleeding in the brain, such as vision or speech changes, weakness or numbness in an arm or leg, or a severe headache.

http://heart.emedtv.com/pradaxa/pradaxa ... tions.html

That last one is a tricky one. Vision and speech changes? Weakness or numbness in an arm or leg? Could be just another day with MS.
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Re: FDA Orders Safety Review of Pradaxa

Postby drsclafani » Mon Dec 12, 2011 2:57 pm

the logic for anticoagulation remains as follows

angioplasty injures intima and exposes elements of the deeper part of the wall of the vein to blood elements such as clotting factors and platelets. The purpose of this reaction is based on the evolutionary advantage of being able to stop bleeding caused by disruption of the wall of blood vessels. Of course, the evolutionary purpose of this reaction wasnt angioplasty it was being bitten by some predator.

Aspirin will reduce the stickiness of platelets and inhibit their aggregation at the site of intimal stretch. IT WILL NOT stop clot formation. Thus i use a clot inhibitor, in this case a thrombin A inhibitor like pradaxa or arixtra. I also use a platelet inhibitor aka known as a baby aspirin.

I have moved from an injectable to oral tablets for my patients beause too many patients had allergic reactions or bleed from the needles used to inject the anticoagulants.

Pradaxa also has allergic reactions but seems less. I would prefer to prescribe the 110 mg dose. I use the 75 mg dose for patients who weigh less than 100 pounds.

A big concern with all these drugs is the effect of renal function. Many of these deaths may be due to over-anticoagulation because kidney failure is not recognized or detected before administering these drugs which are metabolized through the kidney ..If the kidney doesnt do its job, then drug accumulates and renders the patient totally over angicoagulated.

For Mark, there are no blood tests that can be used when using the medications.

i await FDA guidance.
Salvatore JA Sclafani MD
Patient contact: ccsviliberation@gmail.com
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Re: FDA Orders Safety Review of Pradaxa

Postby Cece » Mon Dec 12, 2011 5:26 pm

drsclafani wrote:A big concern with all these drugs is the effect of renal function. Many of these deaths may be due to over-anticoagulation because kidney failure is not recognized or detected before administering these drugs which are metabolized through the kidney ..If the kidney doesnt do its job, then drug accumulates and renders the patient totally over angicoagulated.

The serum creatinine test prior to angioplasty (to make sure the kidneys can withstand the contrast) would cover this. Good to know.
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Re: FDA Orders Safety Review of Pradaxa

Postby Cece » Tue Dec 27, 2011 5:33 pm

http://www.reuters.com/article/2011/11/ ... 9K20111112
European regulators last month said that patients about to take Pradaxa should have their kidneys checked, and Japanese regulators told Boehringer in August to issue a strong warning to doctors of potentially deadly bleeding as a result of use of Pradaxa.


More support for what Dr.Sclafani said above, that if kidneys are dysfunctional and fail to process out the Pradaxa, too much can build up and may lead to bleeding.

So my question: Every patient in the US has a serum creatinine test before the CCSVI procedure, correct? Is this also true in the more far-flung locales?
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Re: FDA Orders Safety Review of Pradaxa

Postby Cece » Sat Nov 03, 2012 1:40 pm

http://www.medpagetoday.com/Cardiology/ ... id=5517461

Pradaxa Holds No Extra Bleeding Risk, FDA Says


Safety review is complete and no extra bleeding risk was found.
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Re: FDA Orders Safety Review of Pradaxa

Postby David1949 » Sat Nov 03, 2012 9:38 pm

About 3200 Americans have died as a result of terror attacks in the US in the last 20 years.
That averages out to 160 per year.

According to this article http://www.medicalnewstoday.com/releases/11856.php
an average of 195,000 people in the USA died due to potentially preventable, in-hospital medical errors in each of the years 2000, 2001 and 2002.

So it seems you are over 1000 times more likely to be killed by medical personnel than by terrorists.
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