Urgent Safety Alert - Heparin, used in bladder instillations, has been recalled.

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Urgent Safety Alert - Heparin Recall Affects IC Patients Using Home or Office Instillations - March 2008 (View on the web)

Have your bladder instillations (rescue instillations, DMSO cocktails, etc) been different in the last two months? (i.e. have they provoked different symptoms, pain, etc. )
Do you do home instillations that use heparin?
THIS RECALL MAY AFFECT YOU. YOU MAY NEED TO TAKE IMMEDIATE ACTION!

If you haven't been following the recall of the blood thinner Heparin that began several weeks ago... you should. Heparin is used in some IC treatments, including rescue instillations and DMSO cocktails. As of last week, all Heparin products made by Baxter International have now been recalled. The alert began in late January when abnormally high levels of adverse events associated with Heparin were noted at hemodialysis centers and hospitals.

Last week, we were shocked to learn that several IC patients were given recalled heparin to use in their home bladder instillations. We are concerned that there are more patients, without access to the web, who may be unaware of the recall.

"After I heard about the recall, I called my "local" pharmacy and they told me they would have to check. They called back about an hour later and said yes, my two day ago refill was part of the recall. Luckily I had not done an instill with my new Rx." - GTG78
"I received a call last night from ... my mail order pharmacy that had filled an order for Baxter brand heparin a month ago. They advised me to stop using it immediately, and that a postage paid envelope would be sent to me and I should mail in the remaining heparin and I would receive a full refund. I was told that there were multiple symptoms caused by this heparin, involving blood pressure issues, burning (I had noticed that!), etc that had caused the recall." - Sugar
"I picked up my RX this morning and when I got home I looked at the vial and it was from Baxter. I called the company and they said yes that it was part of the recall. I called the pharmacy and they had no idea there was a recall. Can you believe it? If it wasn't for you guys I would have put it into my instill. How could a pharmacy not know?" - FENNSM
"I am so glad this was posted because I checked and I have the Baxter brand heparin like everyone else. I'm pretty upset that if there was a recall that my pharmacy didn't call me and tell me. I just got my first mail order supply less than two weeks ago. I'm going to have to call them in the morning and see what they have to say and when they can get me a replacement. This really upsets me since I have been flaring so bad but now can't do an instill." - Griffsmommy

In the past few weeks, some of these patients have also reported that their normal bladder instillations had become unusually painful, possibly due to the contaminated heparin.

"I have also been feeling worse after the instills I have done with this heparin. When done in the DR office they made me feel sooo much better. I was thinking maybe it was the sensorcaine the pharmacy substituted with until my marcaine came in....now I am not so sure." - Leah 78
"I had noticed the same thing w/my instills as of late...lots of burning and discomfort from them, when they were usually quite soothing. I thought it was because my dr had recently changed the recipe and amounts. I was able to get another brand of heparin from my local Walgreens (I still had an old prescription there that I refilled) and that hasnt' burned at all! So I figure it was the Baxter heparin after all. I'm concerned that perhaps it did more harm than good! My pain has been considerably higher...." - Sugar
"Last tuesday was my first rescue instillation and by Fri I started having the worst flair I have ever experienced and is still going on now, none of my pain meds touched it. Could it be because of the instill? I don't have UTI (had it checked) but I would have sworn I did. I normally just experience pain, no frequency but now I have severe pain, frequency, it feels like I have to go right after I just went and lots of pressure." - FENNSM

According to the Baxter International press release of January 28, 2008 … adverse reactions have included: stomach pain or discomfort; nausea; vomiting; diarrhea; low blood pressure; chest pain; fast heart rate; dizziness; fainting; unresponsiveness; shortness of breath; tachycardia; drug ineffectiveness; burning sensation; redness or paleness of skin; abnormal sensation of the skin, mouth, or lips; flushing; increased sweating; decreased skin sensitivity; headache; feeling unwell; restlessness; watery eyes; throat swelling; thirst; and difficulty opening the mouth. Some of these reactions may be severe or life-threatening.

RECALL HISTORY & INVESTIGATION

Jan. 2008 - Baxter International, the CDC and the FDA began noticing significantly higher rate of side effects in January 2008. Normally, they received 60 or so complaints a year but, in January 2008, they had 150 reported side effects..... such a significant increase that it required much further investigation.
Jan. 28 2008 - Baxter announced the first partial recall of heparin. (Read release)
Feb. 28, 2008 - Baxter announced that ALL heparin products were being recalled. (Read Release)
Mar. 6, 2008 - Scientific Protein Labs announces announces that they will remove any lots of China-sourced heparin API where tests have indicated the presence of an extra signal/peak in testing. SPL is notifying customers who have received certain lots of suspected materials. (Read Release)
Mar. 7, 2008 - The FDA reported that new, more sensitive tests of the heparin discovered significant contamination. EACH of the samples tested had between 5% to 20% contaminant per sample. The contaminant is a heparin like molecule that routine industrial testing cannot detect. Read more about the testing here!

The question is... was the contaminant part of a botched production/manufacturing method or was it “intentionally added to reduce costs.” Baxter and FDA representatives are now scrambling for answers. Baxter Chief Medical Officer Janet Woodcock said “We don’t know how… this compound got into the heparin but we are aggressively investigating it.”

Baxter International obtained the product from Scientific Protein Labs (SPL), which has manufacturing plants in both Wisconsin and Chagzou, China. The FDA acknowledged that neither they, nor Chinese authorities, had inspected the Chinese facility, nor does it have certification. In fact, Chinese authorities are only required to inspect facilities that produce for their own domestic market. Companies that produce product for the international market have no mandatory review process. (Source)

SPL CEO David Trunce said that his company had moved all production to China three years ago and that they cannot force Chinese authorities to check their plant. Our conterpoint is an obvious one. Shouldn't SPL and Baxter be conducting their own comprehensive inspections?? Unfortunately, the Chinese do not allow for surprise inspections.

RECALL DETAILS

The recall has been expanded to include ALL BAXTER heparin products, including single use vials. Customers have been instructed to discontinue use and should then contact Baxter to arrange for return and replacement product. Customers with recalled product purchased indirectly should contact their wholesaler or distributor for return and replacement product. Customers with questions may contact Baxter at 1-800-667-0959. Representatives are available Monday through Friday from 7 a.m. to 6 p.m. CT.

WHAT YOU SHOULD DO

- If you experienced unusual or severe symptoms during or after instillations in the past few months, please contact your pharmacist or physician and asked if they used Baxter heparin products. (Remember, your physician or pharmacist would not have known about the expanded recall until March 7, 2008. It's NOT their fault.) If they did use Baxter heparin, please report your symptoms and/or experience to the FDA immediately using their MEDWATCH system at https://www.accessdata.fda.gov/scripts/medwatch/, 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.

- If you believe that you suffered an adverse event from the heparin, please e-mail ICN President Jill Osborne (jill@ic-network.com) your experience. She is also compiling patient reports and trying to advocate for IC patients with the FDA and Baxter. She needs more, indepth, patient reports.

ALTERNATE MANUFACTURERS DIFFICULT TO OBTAIN

Several patients are now reporting that heparin distributed by other companies (i.e. Ameripharm) is on backorder and is much more difficult to locate. Pharmacies are scrambling to find product.

OUR COMMENTS

(From ICN Founder Jill Osborne) WE NEED YOUR HELP URGENTLY!! Each day, thousands of patients across the USA are given bladder instillations using heparin. There are many others doing instillations at home completely unaware of the recall. Urologists and nurse practioners may not know that the recall was expanded to include ALL Baxter heparin products.

PLEASE CALL YOUR DOCTORS OFFICE (and anyone who has helped with your instillations) AND NOTIFY THEM OF THE RECALL. BAXTER HEPARIN SHOULD NOT BE USED . You can also forward this email and/or print out recall information and bring it in.

Unfortunately, this doesn't come as a surprise. While there is no proof that the contaminant is causing these severe reactions, it's strongly suggestive. Chinese manufacturing has a checkered history and it wouldn't surprise me to learn that the contamination originated in the Chagzou facility.

Why?? The water and air pollution crisis in China is so profound that rivers run black from industrial waste and untreated sewage. Seventy percent of China’s rivers and lakes are polluted. More than 360 million people lack access to safe drinking water. Think about it. These are the very waters that may be used to water the crops (i.e. wheat) and/or used during the manufacturing process that we, in the USA, are buying in vast quantities for consumables.

Some Chinese manufacturers and distributors have a track record of putting cash ahead of product quality and safety. When it was discovered that melamine was being added to wheat germ used in pet food and animal feed (chickens, etc.) to artificially raise the protein levels and thus price, it's clear that they don't value the health of the consumer.

Far worse, our increasing reliance on Chinese medications and other consumables appears both risky and foolhardy. The Chinese government has created a system that does not facilitate good quality control and monitoring. Manufacturers could be using unsafe ingredients and/or methods without any safety or quality regulations in place. Drugs that are exported, in contrast to drugs that are used in China, have no government inspection process to verify safety and quality. Foreign companies, such as Baxter, are not allowed to do site inspections on a surprise basis. Corruption also appears to be an issue. In 2007, the head of the Chinese FDA was executed after it was proven that he took bribes to approve drugs.

I, for one, do not want to put the health of my family or pets at risk by using Chinese based pharmaceuticals or consumables. I urge caution. As you consider new prescriptions, ask your pharmacist where the drug came from? If they don't know, contact the company via the web and/or phone. If a US based supplier is present, we think that's the more reliable option to consider.