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Any shared experiences with Xiaflex treatments?
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06/10/2010 14:47
deggleston 
06/10/2010 14:47
deggleston 
Any shared experiences with Xiaflex treatments?

I have significant contractor in both hands and have chosen to go with the Xiaflex treatment. I just finished with my second injection and underwent a manipulation a couple of weeks ago. Because of the confluence and number of my cords involved, there is significant breakage that must occur.

Other than the pain associated with the cord breakage, I am pleased with the results (4 more injections to go). How about others? Care to share your experiences?

Edited 06/10/10 17:48

06/11/2010 00:26
jimh 
06/11/2010 00:26
jimh 
Re: Any shared experiences with Xiaflex treatments?

deggleston, were you part of a trial, or was your MD involved in the trials? I thought Xiaflex wasn't actually available through normal channels just yet.

06/11/2010 21:00
deggleston 
06/11/2010 21:00
deggleston 
Re: Any shared experiences with Xiaflex treatments?

I understand Xiaflex was approved by FDA back in Feb of this year (http://www.fda.gov/NewsEvents/Newsroom/P...s/ucm199736.htm). I tracked the drug through the FDA process, and when released, my MD worked with my insurance company to cover the cost for treatment in both hands.

I've had two treatments so far, and its helping. The pain associated with the cord breakage was the worst part.

06/11/2010 23:10
jimh 
06/11/2010 23:10
jimh 
Re: Any shared experiences with Xiaflex treatments?

Yes it was approved. I didn't realize it was already in distribution.

06/12/2010 03:32
LubaM. 
06/12/2010 03:32
LubaM. 
Re: Any shared experiences with Xiaflex treatments?

deggleston:
I understand Xiaflex was approved by FDA back in Feb of this year (http://www.fda.gov/NewsEvents/Newsroom/P...s/ucm199736.htm). I tracked the drug through the FDA process, and when released, my MD worked with my insurance company to cover the cost for treatment in both hands.

I've had two treatments so far, and its helping. The pain associated with the cord breakage was the worst part.
You mention pain when breaking the cords....was there pain associated with the injections themselves, and did the Dr. give you anestetic before the injections or when breaking the cords ?

Could you please share where you live. Do you know the cost of Xiaflex injections and treatment, and whether Medicare covers it?

thanks.

Edited 06/12/10 06:34

06/12/2010 17:27
tgrunde 
06/12/2010 17:27
tgrunde 
Re: Any shared experiences with Xiaflex treatments?

I went thru the clinical trial, had 6 injections with good results. Nothing bad happened - pain was pretty extreme as there was no pain meds were allowed. I have one cord that wasn't completely snapped and the contracture has come back. My doctor's nurse (Dr. Bear, Rockford IL) just told me that the insurance has not approved and come up with a "J" (?) code needed for medicare coverage. Once they get that they have 40 people on the waiting list - and we get pain meds this time !!

06/17/2010 20:14
guest

not registered

06/17/2010 20:14
guest

not registered

Re: Any shared experiences with Xiaflex treatments?

Another Round of FDA Warning Letters Issued
By Lisa LaMotta Jun 17, 2010 2:45 pm
The government oversight agency issues four more warning letters related to misleading drug marketing.
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Pharmaceutical companies never learn their lessons. It doesn’t seem to matter how many times the FDA cites a company or its competitors for marketing unapproved drugs, misleading marketing, or failing to report adverse events; the companies just keep committing the offenses.

The latest round of warning letters were published on the FDA website on Thursday for issues related mostly to misleading marketing practices. Four companies -- Auxilium Pharmaceuticals (AUXL), Eisai, Sepracor, and Cumberland Pharmaceuticals (CPIX) -- were the current offenders.

The FDA’s Division of drug Marketing, Advertising, and Communication cited Auxilium for a brochure that it put out on its drug Xiaflex, which was approved in February for the treatment of a disease that impairs hand function called Dupuytren’s contraction. The letter, dated June 10, said the brochure “broadens the indication for Xiaflex, overstates the efficacy of Xiaflex, minimizes the risks associated with the use of Xiaflex and omits material facts.”

Cumberland committed similar offenses for its drug Acetadote, which is used for the treatment of acetaminophen overdose. The company is guilty of omitting and minimizing the risks associated with the drug as well.

The company has been considered by some as the worst IPO of the last year. The stock has fallen dramatically, dropping to a price just below $7 from its offering price of $17 last August. The company’s CEO A.J. Kazimi told the Nashville Business Journal that “introducing a product to the hospital market takes time.”

Sepracor was accused of similar transgressions for its sleep-aid Lunesta, while Eisai violated marketing guidelines for its brain-tumor treatment Gliadel in promotional materials on its website.

It’s easy to see why pharmaceutical companies might want to exaggerate the positives and downplay the negatives of their products in advertising. Their bottom line depends heavily on how doctors view the product and if they'll prescribe one particular drug over another. More than 60 warning letters have been issued so far in 2010, with the majority of them relating to advertising.

The FDA tends to post these letters to its site in bunches in an effort to draw more attention to the violations. As evidenced by the number of letters already issued this year, these letters aren't uncommon. Companies receive them for all sorts of violations beyond misleading marketing. Pfizer (PFE) recently made headlines when it received a letter from the FDA for its failure to report adverse side effects for some of its drugs. While all of the safety concerns affiliated with the adverse events have been addressed, the pharmaceutical company is required by law to inform the FDA when these sorts of complaints come in.

The FDA has been cracking down on violations like these more frequently over the last couple of years. The stringent enforcement comes as the agency tries to make itself more transparent to consumers. The new administration at the FDA under the oversight of Commissioner Margaret Hamburg has been trying to improve the agency’s disclosure and formed the Transparency Task Force to propose changes to the current system. If the guidelines are put into place, the public will have more access to other violations that companies have committed.

06/18/2010 17:57
moondanc 
06/18/2010 17:57
moondanc 
Re: Any shared experiences with Xiaflex treatments?

deggleston:
I have significant contractor in both hands and have chosen to go with the Xiaflex treatment. I just finished with my second injection and underwent a manipulation a couple of weeks ago. Because of the confluence and number of my cords involved, there is significant breakage that must occur.

Other than the pain associated with the cord breakage, I am pleased with the results (4 more injections to go). How about others? Care to share your experiences?

Do you know the side effects of Xiaflex? Do you have any idea what the drug--collagenase-- does in the rest of your body and how long it lasts? Do you know what it does to your immune system? Do you know why the FDA has not reqired long-term trials of this drug-Xiaflex--longer than a year-- to find out these things before approving it?

Do you know how long your treatment effects will last and how long your fingers will be straight? What happens to the portion of the cord that is not "dissolved"--Xiaflex breaks the cord just like NA. How much longer than NA does Xiaflex last? Does the drug company Auxilium know? How? What long-term studies do they have to demonstrate long term efficacy of Xiaflex?


My personal experience with Xiaflex in trials--in about a year my finger was back to the same degree of contraction as prior to the trials.

06/18/2010 18:33
deggleston 
06/18/2010 18:33
deggleston 
Re: Any shared experiences with Xiaflex treatments?

Moondanc brings up a good point – How comfortable are you with your treatment choice? I chose Xiaflex based on my own research and treatment options. Every treatment has a certain amount of risk and doing nothing was not an option for me.

06/23/2010 15:37
user714

not registered

06/23/2010 15:37
user714

not registered

stunning

The latest round of warning letters were published on the FDA website on Thursday for issues related mostly to misleading marketing practices. Four companies -- Auxilium Pharmaceuticals (AUXL), Eisai, Sepracor, and Cumberland Pharmaceuticals (CPIX) -- were the current offenders.

The FDA’s Division of drug Marketing, Advertising, and Communication cited Auxilium for a brochure that it put out on its drug Xiaflex, which was approved in February for the treatment of a disease that impairs hand function called Dupuytren’s contraction. The letter, dated June 10, said the brochure “broadens the indication for Xiaflex, overstates the efficacy of Xiaflex, minimizes the risks associated with the use of Xiaflex and omits material facts.”



Omits material facts? like the fact that NA exists and works better, perhaps?!!!

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