• Welcome, Guest. Please login or register.
    October 20, 2018, 04:47:58 AM

  • Login with username, password and session length

Sajid's dove

Tell everyone they can now find this site by typing this into their browser:

thalpal.com

Click to visit us on Facebook


If you have any problems registering or signing in, please send an email to: andy@thalpal.com
Please do not send questions about thalassemia to this address.


Administrators
Andy
Danielle

Thalassemia Patients and Friends and thalpal © A. Battaglia 2018





54795 Posts in 5812 Topics by 6052 Members
Latest Member: Rochwani Hitesh Ramchandr

Forum Tip: 
You can now simply type thalpal.com into your browser and it will take you to this site. Tell your friends about this easy-to-remember name.
www.thalpal.com
« previous next »
Pages: 1 Go Down Print
Author Topic: Desferal NATIONAL BACKORDER!!!?  (Read 3849 times)
CrazyPharm
Active Member
**
Offline Offline

Location: USA

Gender: Male
Posts: 43


« on: January 31, 2018, 08:35:42 AM »

I have some sad/scary news to share. I was just informed by my Pharmacy that generic deferoxamine is on a USA national backorder until end of 2019!!

I am devastated and dont know what to do. I am solely dependent on deferoxamine for my chelation and cannot take/tolerate the alternatives. I’m lost and don’t know what to do. Perhaps buy some deferoxamine/desferal from international sources or fly out somewhere to pick it up.

DOES ANYONE HAVE ANY ADVICE OR GUIDANCE PLEASE
Logged
Andy Battaglia
Administrator
Supreme Member
*****
Offline Offline

Location: In my heart, Maldives

Gender: Male
Posts: 8476


Will thal rule you or will you rule thal?


« Reply #1 on: January 31, 2018, 12:37:01 PM »

Please contact Eileen at CAF and find out of this is true and if she can recommend a solution.

Cooley's Anemia Foundation
330 Seventh Avenue, #900
New York, NY 10001
212-279-8090
Fax: 212-279-5999

Patient Services Manager
Eileen Scott
escott@thalassemia.org
Logged

Andy

All we are saying is give thals a chance.
CrazyPharm
Active Member
**
Offline Offline

Location: USA

Gender: Male
Posts: 43


« Reply #2 on: January 31, 2018, 06:05:46 PM »

I spoke to Eileen today and this is indeed true. They are working on figuring out what to do. There’s not much that can be done in these situations as even the manufactures can’t help themselves.
Logged
Andy Battaglia
Administrator
Supreme Member
*****
Offline Offline

Location: In my heart, Maldives

Gender: Male
Posts: 8476


Will thal rule you or will you rule thal?


« Reply #3 on: February 09, 2018, 03:17:12 PM »

CAF posted this update today. http://www.thalassemia.org/generic-desferal-shortage-looming-in-u-s/

Quote
Generic Desferal Shortage Looming in U.S.
February 8, 2018 – As some of you have already heard, there is a shortage of the generic form of Desferal (commonly referred to as deferoxamine mesylate) in the United States. Cooley’s Anemia Foundation has been following this situation as it has developed and has been in touch with all of the major players. To summarize the situation, Pfizer Injectables, which supplies the majority of deferoxamine mesylate in the United States, will not be shipping any new deferoxamine until March, 2019 at the earliest and that it will not be back to supplying the full amount I has typically supplied until June, 2019 at the earliest.

Fresenius Kabi, which also manufactures deferoxamine mesylate for the U.S., is aware of the situation and is making as much of the drug available as it can; however, it will not be able to produce enough to cover the shortfall caused by Pfizer Injectables’ absence. Novartis is continuing to produce the brand name version (Desferal) and also knows of the shortage; again, however, Novartis is not going to be able to overcome the shortfall either.

We do know of at least one other company which has had plans for some time to produce deferoxamine mesylate for sale in the U.S., and this will help to alleviate the shortage; however, we do not have a definite timeline of when this source will be able to launch in the United States.

CAF has been in touch with the US Food and Drug Administration, which is well aware of the shortage and has been working with manufacturers to try to help alleviate the situation.

US thalassemia patients who use generic deferoxamine mesylate should be aware that this shortage is likely to affect them and may do so for many months. We encourage you to talk with your hematologist and/or nurse about chelating options you may want to consider until the shortage issue has been resolved.

In our conversation with the FDA, we mentioned that some patients may try to find an overseas source to supply deferoxamine mesylate. (Because this means that the drug would not have passed through FDA evaluation, CAF does NOT recommend this option; any patient considering this should do so only after consultation with their hematologist.) However, for patients investigating this option, the FDA informed us about a policy for patients who may have identified product that they would like to use from an overseas source, making the decision to use that source in conjunction with their physician. That information follows below.

CAF will continue to monitor the situation and update patients of any developments we learn about.

FDA’s Personal Importation Policy:

There is a policy called FDA’s personal importation policy where  a patient is importing less than a 3 month supply of a medically necessary drug and here is how that works:

FDA does not object to individuals importing small shipments of medical drugs that are treatments not otherwise available in the US for their own use. As such, the importation of the drug would be allowable for personal use and in a quantity commensurate with personal use (generally not more than 3 month supply).

At the time of importation, if the package is stopped by FDA , the patient is  provided notice that the product is stopped and contact information within FDA. The patient should be prepared to provide an affirmation that the product is for personal use, the drug is in shortage, and that the patient will be taking the medication under the care of a physician. This can be done in a short letter, there is no official form or format for this. The patient may even be able to have the pharmacy or company they are importing from  include their  letter and a prescription for the patient  signed by a physician in the package they ship.

This entry was posted on Thursday, February 8th, 2018 at 5:18 pm   
Logged

Andy

All we are saying is give thals a chance.
EugenioLaMesa
Cure Thalassemia co-founder and chairman
Active Member
**
Offline Offline

Location: Rome

Gender: Male
Posts: 61



WWW
« Reply #4 on: February 15, 2018, 02:57:20 AM »

Andy, do you think that it is going to happen also in other countries?
Logged

Eugenio La Mesa
Co-founder and Chairman
Cure Thalassemia
Live without Thalassemia major - No more transfusions
Become our fan on Facebook: http://fb.com/CureThalassemia
Andy Battaglia
Administrator
Supreme Member
*****
Offline Offline

Location: In my heart, Maldives

Gender: Male
Posts: 8476


Will thal rule you or will you rule thal?


« Reply #5 on: February 25, 2018, 12:26:36 PM »

Eugenio, it has already happened in India and Pakistan.
Logged

Andy

All we are saying is give thals a chance.
EugenioLaMesa
Cure Thalassemia co-founder and chairman
Active Member
**
Offline Offline

Location: Rome

Gender: Male
Posts: 61



WWW
« Reply #6 on: March 08, 2018, 12:16:46 PM »

ok Andy, thanks.
Logged

Eugenio La Mesa
Co-founder and Chairman
Cure Thalassemia
Live without Thalassemia major - No more transfusions
Become our fan on Facebook: http://fb.com/CureThalassemia
Pages: 1 Go Up Print 
« previous next »
Jump to:  

Powered by MySQL Powered by PHP Powered by SMF 1.1.21 | SMF © 2015, Simple Machines Valid XHTML 1.0! Valid CSS!