This is from 2010-- an FDA warning to Auxilium

http://www.bizjournals.com/philadelphia/...14/daily33.html

Here's a partial quote -"The Food and Drug Administration .. has issued a letter to Auxilium Pharmaceuticals Inc. .. stating that the company overstated the effectiveness of its newest drug, Xiaflex."

Here's the actual FDA warning letter (this was posted to the forum in 2010):

http://www.pharmcast.com/WarningLetters/...uticals0610.htm

I believe Auxilium has followed the request of the FDA and changed their marketing techniques but I still find the claims and omissions pretty scary.

Here's some data from this year that I don't believe has yet been published. It's an inquiry as to whether surgery is more difficult after Xiaflex injection:
http://c230337.r37.cf1.rackcdn.com/RF020_abstract.pdf

Here are some of the findings:

"Natural history data and presented CCH [Xiaflex] injection results suggest recurrence in a significant
percentage of patients after either injection or surgical treatment,"

Moondanc

Take a look at this--check out the link and read the excerpts I've pasted below:

https://www.xiaflex.com/hcp/XIAFLEX_adverse_events.jsp

in a trial of 249 patients 98% had adverse reactions.


Tendon Rupture or Other Serious Injury to the Injected Extremity

In the controlled and uncontrolled portions of the clinical trials, flexor tendon ruptures occurred after XIAFLEX injection. Injection of XIAFLEX into collagen-containing structures such as tendons or ligaments of the hand may result in damage to those structures and possible permanent injury such as tendon rupture or ligament damage. Therefore, XIAFLEX should be injected only into the collagen cord with a MP or PIP joint contracture, and care should be taken to avoid injecting into tendons, nerves, blood vessels, or other collagen-containing structures of the hand. When injecting a cord affecting a PIP joint of the fifth finger, insert the needle no more than 2 to 3 mm in depth and avoid injecting more than 4 mm distal to the palmar digital crease.

Other XIAFLEX-associated serious local adverse reactions in the controlled and uncontrolled portions of the studies (N=1082) included:
•3 flexor tendon ruptures in small finger PIP joint (0.3%)
•1 pulley ligament injury (0.1%)
•1 complex regional pain syndrome (0.1%)
•1 sensory abnormality of the hand (0.1%)

Allergic Reactions

In the controlled portions of the clinical trials (Studies 1 and 2), a greater proportion of XIAFLEX-treated patients (15%) compared to placebo-treated patients (1%) had mild allergic reactions (pruritus) after up to 3 injections. The incidence of XIAFLEX-associated pruritus increased after more XIAFLEX injections.

Although there were no severe allergic reactions observed in the XIAFLEX studies (eg, those associated with respiratory compromise, hypotension, or end-organ dysfunction), severe reactions including anaphylaxis could occur following XIAFLEX injections. XIAFLEX contains foreign proteins and patients developed IgE-anti-drug antibodies in greater proportions and higher titers with successive XIAFLEX injections. Healthcare providers should be prepared to address severe allergic reactions following XIAFLEX injections.

Is there anything or anywhere that reports the certifications of the docs who did the treatments - were they hand specialists, newbies or GPs treating severe and/or Dupuytren's hands? This makes a huge difference, I think!

Moondanc,

My Dad and I were a part of that study under Dr. Roeshot. I too agree I would never have participated had I known more. My Dad passed away in mid 2010 from leukemia. I often question myself if this helped accelerate his condition and/or caused it. This always weighs on my mind because I talked him into doing the trials with me. We both had the real thing and we came away with straighter fingers but it hurt like hell!!! Mine came back with in 8 to 11 months. Had NA on same fingers one year ago and need to have them done again. I have several cords and nodules in both hands, lumps and bumps on both feet and Peyronies that started about two years ago. The worst part of it is I'm only 43 yrs old.

With that said I will NEVER use the xiaflex again. Thanks for listening or should I say reading.

Joe

This thread and the "After Xiaflex" one are kind of going in the same direction. The information in the other thread about possible systemic problems with connective tissues is scary stuff. (My husband is among the tiny percentage of folks who have survived an aortic dissection. Trust me, that's one medical nightmare you wouldn't wish on anyone.) I have wondered, since the stereotype of Dupuytren's patients is that we are old, what the potential is for Xiaflex-related problems years down the road. Someone who gets the drug in their 40s or 50s has many more years to live with the risks than someone who is 70 or 80 at the time of treatment.

I'm not a candidate for the stuff, as my doctor says it's out of the question because the areas I would need treated would take four or more vials of it- who has that kind of $$$ in any case? My disease is quite aggressive. My hand was absolutely fine a year ago when I had trigger finger surgery: I had significant nodules, cords, and contracture less than three months after that, and even more cropped up after a fasciectomy in May. It sounds like X can be even a better trigger than surgery or other trauma in susceptible people. I hate to think what shape I could be in had I tried it after reading what others here have said.