This Is MS Multiple Sclerosis Community: Knowledge & Support

Welcome to the world's leading forum on Multiple Sclerosis research, support, and knowledge. For over 10 years, This is MS has provided an unbiased community dedicated to Multiple Sclerosis patients, caregivers, and affected loved ones.
It is currently Sat May 18, 2013 4:31 am


All times are UTC - 8 hours [ DST ]




Post new topic Reply to topic  [ 13 posts ] 
Author Message
PostPosted: Wed Dec 07, 2011 4:18 pm 
Offline
Family Elder

Joined: Mon Jan 04, 2010 4:00 pm
Posts: 8505
http://www.medpagetoday.com/Cardiology/ ... aking-news

Quote:
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?


Top
 Profile  
 
PostPosted: Thu Dec 08, 2011 1:57 am 
Offline
Family Elder
User avatar

Joined: Wed Jul 27, 2005 3:00 pm
Posts: 2684
Location: Sydney, Australia
My tablets used after I arrived back in Australia were 110mg. However, Dr Sclafani's first choice was an injectible.


Top
 Profile  
 
PostPosted: Thu Dec 08, 2011 8:08 am 
Offline
Family Elder
User avatar

Joined: Fri Apr 01, 2011 3:00 pm
Posts: 305
Location: Canada
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.

Top
 Profile  
 
PostPosted: Thu Dec 08, 2011 8:37 am 
Offline
Family Elder

Joined: Mon Jan 04, 2010 4:00 pm
Posts: 8505
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?


Top
 Profile  
 
PostPosted: Thu Dec 08, 2011 8:42 am 
Offline
Family Elder
User avatar

Joined: Fri Apr 01, 2011 3:00 pm
Posts: 305
Location: Canada
:oops:


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

Top
 Profile  
 
 Post subject: People are different
PostPosted: Thu Dec 08, 2011 9:24 am 
Offline
Family Elder
User avatar

Joined: Thu Oct 19, 2006 3:00 pm
Posts: 1052
Location: Oxfordshire, England
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). 10 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


Top
 Profile  
 
 Post subject: Re: People are different
PostPosted: Fri Dec 09, 2011 12:52 am 
Offline
Family Elder
User avatar

Joined: Wed Jul 27, 2005 3:00 pm
Posts: 2684
Location: Sydney, Australia
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)


Top
 Profile  
 
PostPosted: Fri Dec 09, 2011 7:18 am 
Offline
Family Elder

Joined: Mon Jan 04, 2010 4:00 pm
Posts: 8505
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....
Quote:
•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.


Top
 Profile  
 
PostPosted: Mon Dec 12, 2011 2:57 pm 
Offline
Family Elder
User avatar

Joined: Fri Mar 12, 2010 4:00 pm
Posts: 2977
Location: Brooklyn, New York
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


Top
 Profile  
 
PostPosted: Mon Dec 12, 2011 5:26 pm 
Offline
Family Elder

Joined: Mon Jan 04, 2010 4:00 pm
Posts: 8505
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.


Top
 Profile  
 
PostPosted: Tue Dec 27, 2011 5:33 pm 
Offline
Family Elder

Joined: Mon Jan 04, 2010 4:00 pm
Posts: 8505
http://www.reuters.com/article/2011/11/ ... 9K20111112
Quote:
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?


Top
 Profile  
 
PostPosted: Sat Nov 03, 2012 1:40 pm 
Offline
Family Elder

Joined: Mon Jan 04, 2010 4:00 pm
Posts: 8505
http://www.medpagetoday.com/Cardiology/ ... id=5517461

Quote:
Pradaxa Holds No Extra Bleeding Risk, FDA Says


Safety review is complete and no extra bleeding risk was found.


Top
 Profile  
 
PostPosted: Sat Nov 03, 2012 9:38 pm 
Offline
Family Elder

Joined: Mon Aug 23, 2010 3:00 pm
Posts: 596
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.


Top
 Profile  
 
Display posts from previous:  Sort by  
Post new topic Reply to topic  [ 13 posts ] 

All times are UTC - 8 hours [ DST ]


Related topics
 Topics   Author   Replies   Views   Last post 
There are no new unread posts for this topic. pradaxa and sideeffects

Nasti

0

1002

Wed Jul 07, 2010 2:34 pm

Nasti View the latest post

There are no new unread posts for this topic. Pradaxa lacks a reversal antidote

Cece

0

562

Tue Mar 20, 2012 10:05 am

Cece View the latest post

There are no new unread posts for this topic. Pradaxa rushed to market - puts elderly at risk

HappyPoet

4

1375

Wed Sep 14, 2011 9:32 am

Kathyj08 View the latest post

There are no new unread posts for this topic. making it to safety

Cece

8

1468

Thu Jan 20, 2011 6:11 pm

1eye View the latest post

There are no new unread posts for this topic. a different take on the ccsvi safety studies

Cece

2

930

Wed Jun 15, 2011 3:10 am

NHE View the latest post

 


Who is online

Users browsing this forum: No registered users


You cannot post new topics in this forum
You cannot reply to topics in this forum
You cannot edit your posts in this forum
You cannot delete your posts in this forum

Search for:
Jump to: