Janbaekelandt

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Again, welcome!  JFW | T@lk 14:49, 3 August 2012 (UTC)

Dabigatran

Thank you for your additions to dabigatran. I have removed one of them, which is the observation from the FDA about the absolute number of adverse events. The source was a lot more balanced (see WP:NPOV), in the sense that it made a point about the fact that warfarin use might have led to a similar number of adverse events but they would not be reported to the FDA because it's been around since the 1960s. I would have no objection to returning the content, but only if it can be presented in a more neutral version. Perhaps you could provide some views on Talk:Dabigatran so we can discuss them there before going live. JFW | T@lk 14:49, 3 August 2012 (UTC)

I have again removed the dubious claim about reporting. The claim about "unusually severe" bleeding looks highly circumstantial. One cannot infer that from the fact that most reports came from health professionals. Please discuss on Talk:Dabigatran. I am increasingly concerned that you are adding content in an unbalanced fashion from sources that fall short of the requirements from WP:MEDRS. JFW | T@lk 22:44, 4 August 2012 (UTC)

JfdWolf I have great admiration for the work you do for wikipedia.

I agree with the removing of "suggesting that despite this well-known drug risk the bleeding was unexpected or unusually severe". Although, this is a sentance of the report. I don't agree with the removing of the whole paragraph. Because these are facts.

Is QuarterWatch a source that fal short of the reguirements of wikipedia??? Can you give one source that was used by me that fellt short of requirements from wikipedia??? Are the FDA reviewers and the EMA reviewers no good sources? Is the Canadian Therapeutics Letter no good source? What is unbalanced ?

I found it very unbalanced that the dabigatran article didn't mention that there is a serious bleeding risc for both warfarin and dabigatran; maybe a litle bit more for warfarin in the trial. But in real world in the US and in Western-Europe with good INR controle centers there is no difference.

In Pharmacovigilance i could ad the Australian Adverse events reported to the TGA for dabigatran June 2009 - Oct 2011, and the important messages given there. "The analysis of these reports shows that some of the bleeding adverse events occurred during the transition from warfarin to dabigatran; many of the adverse events are occurring in patients on the reduced dosage regimen; and the most common site of serious bleeding for dabigatran is the gastrointestinal tract, whereas for warfarin it is intracranial. Risk factors for bleeding: Age ≥ 75 years; Moderate renal impairment (30-50 mL/min) - severe renal impairment is a contraindication; Concomitant use of aspirin (approximately twice the risk), clopidogrel (approximately twice the risk), non-steroidal anti-inflammatory drugs including COX-2 inhibitors Monitoring renal function New recommendations for assessing renal function before starting dabigatran and during its use are now in place." http://www.tga.gov.au/hp/msu-2011-06.htm#pradaxa or http://www.theheart.org/article/1291757.do

These things are very relevant for patiënts and healthcare professionals.

What do you think?

Dr Jan Baekelandt GP during 33 years no conflicts of interest

With a number of these sources, there is a very real risk of falling foul of the guidance from WP:MEDRS. These are primary sources, often methodologically very weak. I am also concerned about WP:RECENTISM - a lot of safety signals from postmarketing surveillance turn out to be untrue. Do we need to alarm the general public about something that (in the fullness of time) will turn out to be wrong?

I'd prefer if we carried on discussing on Talk:Dabigatran, because it allows other editors to weigh in. JFW | T@lk 16:54, 10 August 2012 (UTC)

Disambiguation link notification for August 27

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Dabigatran (check to confirm | fix with Dab solver)

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New paragraph

Please don't use <br /> to begin a new paragraph. Two carriage returns is sufficient. JFW | T@lk 20:13, 29 August 2012 (UTC)

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Copy and pasting

All your edits appear to be. Doc James (talk · contribs · email) (if I write on your page reply on mine) 01:42, 21 July 2014 (UTC)

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