icnmgrjill
03-10-2008, 02:22 PM
Folks... Here's the text of a letter that I've been sending out today to the IC researchers, clinicians that I know of. We really need to get this word out ASAP!!!! Please print and pass along to any of your doctors, nurses, etc that are performing instillations
Dear IC Researcher/Clinician,
If you are unaware of the current Baxter Heparin recall, we wish to notify you that we have received reports from patients who have been given recalled Heparin in various bladder instillations with moderate to severe reactions. Some patients have reported that instillations have caused severe pain and IC flares not responsive to pain medication. Others report severe burning both during and after the instillation. Remarkably, some of these patients have noted that as soon as they used a different source of Heparin, the pain and discomfort did not occur and that the instillation, yet again, had a soothing rather than irritating effect.
In January, Baxter, the CDC and FDA noticed a significant increase in serious adverse events, including 19 fatalities. In late January, a partial recall was announced. Last week, Baxter announced that ALL Baxter Heparin products are now being recalled.
Additional testing has discovered significant contamination with a Heparin like material. Each sample contained between 5 and 20% of this contaminant by total mass. The two methods include proton nuclear magnetic resonance (H-1 NMR) and capillary electrophoresis (CE). (The tests are to be used for ALL Heparin Sodium API prior to batch release. The API material is considered contaminated if there is a doublet peak at 2.1 ppm in H-1 NMR and a shoulder peak in CE, as illustrated in the two attachments. Heparin sodium API must contain only a single peak (singlet) at 2.1 ppm in NMR and a single peak in CE.)
FDA and Baxter officials are scrambling to determine where this has come from. It could be a bi-product of the manufacturing process or it could have been added to the HAPI. There is no conclusive proof that the contaminant has triggered the adverse events, but research is still underway.
I write to you with a request for help.
#1 – We are deeply concerned about patients who may have received instillations and suffered adverse events. Have you noticed an increase in the past two months? If so, please share some of these with us so that we can track reports. In addition, the FDA is asking health care providers to file adverse reports with FDA Medwatch Program at http://www.fda.gov/medwatch/report/hcp.htm, by fax to 1-800-FDA-0178, by mail using the postage-paid address form provided on line, or by telephone to 1-800-FDA-1088.
#2 – We continue to receive reports from patients who had been given a three month supply of now recalled Baxter Heparin for home instillations. We urge you to contact any home instillation patients you may have to inform them of the recall.
#3 – Many medical care providers are under the mistaken assumption that it is still a partial recall. They are unaware that the recall was expanded. Can you please notify clinic and pharmacy personnel, particularly those involved with instillations, about the expanded recall. Heparin is now on backorder from many of the other manufacturers and is getting very hard to locate for non-life threatening purposes.
We thank you for your assistance. Again, I would love to hear any comments you might have on this recall and events you may have noticed in the past few months. I fear that we may have thousands of patients who have suffered unnecessarily and who may not seek additional medical care due to the pain of the contaminated instillation.
All ideas & comments are welcome! Thank you for your attention.
Jill Osborne, MA (jill@ic-network.com)
President & Founder
Interstitial Cystitis Network – http://www.ic-network.com
Reference:
http://www.fda.gov/cder/drug/infopage/heparin/default.htm
http://www.ic-network.com/newsletters/consumeralert0308.html
Dear IC Researcher/Clinician,
If you are unaware of the current Baxter Heparin recall, we wish to notify you that we have received reports from patients who have been given recalled Heparin in various bladder instillations with moderate to severe reactions. Some patients have reported that instillations have caused severe pain and IC flares not responsive to pain medication. Others report severe burning both during and after the instillation. Remarkably, some of these patients have noted that as soon as they used a different source of Heparin, the pain and discomfort did not occur and that the instillation, yet again, had a soothing rather than irritating effect.
In January, Baxter, the CDC and FDA noticed a significant increase in serious adverse events, including 19 fatalities. In late January, a partial recall was announced. Last week, Baxter announced that ALL Baxter Heparin products are now being recalled.
Additional testing has discovered significant contamination with a Heparin like material. Each sample contained between 5 and 20% of this contaminant by total mass. The two methods include proton nuclear magnetic resonance (H-1 NMR) and capillary electrophoresis (CE). (The tests are to be used for ALL Heparin Sodium API prior to batch release. The API material is considered contaminated if there is a doublet peak at 2.1 ppm in H-1 NMR and a shoulder peak in CE, as illustrated in the two attachments. Heparin sodium API must contain only a single peak (singlet) at 2.1 ppm in NMR and a single peak in CE.)
FDA and Baxter officials are scrambling to determine where this has come from. It could be a bi-product of the manufacturing process or it could have been added to the HAPI. There is no conclusive proof that the contaminant has triggered the adverse events, but research is still underway.
I write to you with a request for help.
#1 – We are deeply concerned about patients who may have received instillations and suffered adverse events. Have you noticed an increase in the past two months? If so, please share some of these with us so that we can track reports. In addition, the FDA is asking health care providers to file adverse reports with FDA Medwatch Program at http://www.fda.gov/medwatch/report/hcp.htm, by fax to 1-800-FDA-0178, by mail using the postage-paid address form provided on line, or by telephone to 1-800-FDA-1088.
#2 – We continue to receive reports from patients who had been given a three month supply of now recalled Baxter Heparin for home instillations. We urge you to contact any home instillation patients you may have to inform them of the recall.
#3 – Many medical care providers are under the mistaken assumption that it is still a partial recall. They are unaware that the recall was expanded. Can you please notify clinic and pharmacy personnel, particularly those involved with instillations, about the expanded recall. Heparin is now on backorder from many of the other manufacturers and is getting very hard to locate for non-life threatening purposes.
We thank you for your assistance. Again, I would love to hear any comments you might have on this recall and events you may have noticed in the past few months. I fear that we may have thousands of patients who have suffered unnecessarily and who may not seek additional medical care due to the pain of the contaminated instillation.
All ideas & comments are welcome! Thank you for your attention.
Jill Osborne, MA (jill@ic-network.com)
President & Founder
Interstitial Cystitis Network – http://www.ic-network.com
Reference:
http://www.fda.gov/cder/drug/infopage/heparin/default.htm
http://www.ic-network.com/newsletters/consumeralert0308.html