Latest in a series of e-patient requests.
A good friend overseas writes that due to a fracture and other conditions she’s on Xarelto, a drug to prevent blood clots. (Here’s the drug’s page from the EMA, “the European FDA.”) The drug is causing serious issues with her blood and liver enzyme numbers and may be discontinued next week. Meanwhile she seeks e-patient advice in addition to everything she’s already found.
Her questions:
Are there any reports of adverse events from patients on the drug?
Is there anywhere online to discuss the drug with patients who are on it?
Any other suggestions?
Thanks!
(Via e-patient buddy @Stales, here also is the FDA’s info PDF on the drug, and the drug’s page from PubMed Health.)
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202439s001lbl.pdf
Here’s the FDA-approved label. It has some info on adverse events.
There’s also lots more info here: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022406Orig1s000TOC.cfm
Thanks, Marilynn. Any idea how to connect with patients for info that the FDA hasn’t seen yet?
I well remember when my kidney cancer community noticed a side effect of Sutent within months after its approval, simply because far more diverse patients used it than were in the trials. And of course it can take ages for adverse events to show up in publications, as you know.
This is a fairly new drug. It is used to prevent stroke in patients with atrial fibrillation and to prevent DVT in patients who have had joint replacements. I see the Atrial Fibrillation Association has an online community so even though she is taking it for a different reason she could post a question there.
https://healthunlocked.com/afassociation
The extension of the use of Xarelto for patients in risk of pulmonary embolism and DVT is the latest one. Besides, these patients take a lower dose of the medicine that is 10mg or 15mg twice daily for the first month, then take it for 2-3months at 10mg/twice daily depending on the severity of the case.
Initially, it was indeed prescribed for patients who had a stroke or are in treatment for atrial fibrilation..
The assessment history of Xarelto is here http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000944/human_med_001155.jsp&mid=WC0b01ac058001d124
It might be that EMA assessments/reports on AEs are at a later date than those of the FDA. Another point to note is that the EMA allowed patients only last year to directly report AEs and not exclusively through a physician or pharmacist as before.
I agree with Dave that adverse events on a new drug, particularly an expensive one (each 10mg pill costs 2.85euro=3.86USD or 8.55euro/day for 30mg/day) take a long time to surface online. All the more as many patients/doctors prefer the lower cost tummy injections e.g IVOR.
Hi Dave – tell your friend to check out the MedsChat forum – http://www.medschat.com/Discuss/Xarelto/ or User Reviews at Drugs.com – http://www.drugs.com/comments/rivaroxaban/xarelto.html
She can also pose her own questions on each site.
regards,
C.
Thanks for sharing Carolyn! Wonder whether these sites are not widely known in Europe….
[Note from Dave: this comment was submitted from one particular attorney; it was clearly promotional in wording, enough that it’s almost spam. But it’s relevant, so I’ve edited it to be more broadly informative.]
[From the original comment:] Xarelto Lawsuits have now been consolidated into Multi-District Litigation (MDL).
[My version of the ad-like links that followed:]
Google “Lake APC” for the attorney who posted this, or “xarelto multi-district litigation” for news coverage and ads from many other attorneys who are piling on.