Heparin Recall

[Judy777]

Has anyone read about the Heparin recall?

At first they were only recalling certain types of Heparin made by Baxter Healthcare Corp. Now it seems they are recalling all of the Baxter Healthcare Corp. Heparin except the large volume parenteral solutions containing 200 Units of heparin per 100 cc in 500 and 1000 cc total volume bags.

Here is the link to the FDA website
http://www.fda.gov/cder/drug/infopage/heparin/public_health_update.htm

Judy

[sugar]

I received a call last night from Medco, 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.
I have sent an email to Jill to advise anyone else using Baxter heparin of the recall. Hope this helps. PM me if you have any questions.
Thanks,
Annette

[tigger_gal]

Thank you for being on top of things. :) My instills don't require heprin, but many of us here do..

[kadi]

I checked my heparin last night & it is Baxter. I tried to call the pharmacy (also a mail order one) & paged the on call pharmacist, but no one called back.
I'm not worried about a refund, I want to know if/when I'll get replacement medicine!

[Berkshire Road]

Wow, this is what I have too. I get it from my doctor; guess I'll be calling them bright and early Monday morning. This sucks.

[SharonA]

It's too bad that they didn't give any of you an alternative Heparin made by another company. :hmm:

[kadi]

Update, my pharmacy said all the heparin they get is Baxter. The pharmacist said he'll call me Monday when they figure out how/when they'll get replacement medicine. Of course, I've been flaring off/on for several weeks (mystery flares, haven't changed diet or activities, no infection), so I've been doing the instills every night and also some mornings so I can go to work. Sigh.

[sugar]

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, but I thought it was stress. Hopefully it will calm down soon.
Thanks!
Annette

[FENNSM]

I just want to thank you so much for the info on the heparin recall. 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? Anyways they told me to bring it back but they can't find another brand of heparin anywhere. They said it is on backorder and will be for quite awhile. Do you guys have any idea what to do? I do have a call in to the doctor but not sure how much they can help:confused:
Thanks so much!

[bunnykinb]

Well, that is scary. Right now, I am getting heparin instills at the office. I'll have to call and see about the brand used.

[catlover2]

Medco is not currently mailing its Heparin patients a replacement because they do not have any Heparin in stock. They are working on creating contracts with APP Pharmaceuticals, Hospira, and B. Braun so that they can start mailing out Heparin again. I talked with a Medco Pharmacist earlier tonight and she said that Medco doesn't know how long it will be before the contracts are signed and until then they are advising patients to get their Heparin prescriptions filled at a local pharmacy.
THE BAD NEWS: for those of us who currently use Baxter's 10,000U/ml single dose vial Heparin, there are currently no other companies who manufacturer Heparin like it.
For those patients who are trying to replace their heparin: APP Pharmaceuticals will only ship 1 week supplies at a time to patients until further notice. Patients will need to have their pharmacist contact APP to arrange for weekly drop shipments.

[kadi]

This is a mess. I can't even go into the details on it, I'm so stressed. 4 hours on the phone & in pharmacies today & I got a "maybe" on 10 vials (about 2 weeks worth) & of course the problem may be worse in 2 weeks as more & more pharmacies become aware of this & patients start coming in....

So upset, so tired. And without the heparin, the instillation (now just marcaine, sod bicarb & water) only lasts about 4 or 5 hours, which means it's wearing off before my work day is over....

[GriffsMommy]

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.

[Berkshire Road]

It is weird, isn't it, that no one notified so many of us? But I've been using this batch for a while with no problems. Obviously I stopped using it for now, but I need to talk to my dr. It seemed like the problem was with the injection site, and since we don't inject, there's still a question for me.

[Judy777]

I heard about this Heparin recall on the radio from one of our local AM stations while I was driving to work a few weeks ago. They had the original recall over a month ago and it was only specific lot numbers of the Baxter Heparin. Which is what I use and it seems most of use. Baxter produces about 50% of the Heparin sold in the United States. I checked my box of Heparin and it did not have the lot numbers that were involved in the recall.

I am kind of amazed how this heparin from Baxter (all of the vial type that we use) has been recalled and no one has contacted any of the patients who use it. I never received a call from my Pharmacy or Doctors office nothing. The recall did say that the problems with the Heparin seemed to be what they call blous dosing (quick large dose of Heparin). Read below it does mention that if the Heparin is being used for a flush that it should not effect these people.

2. What products and what patients will be affected by this?

Products affected are: Baxter’s Heparin Sodium Injection multiple-dose vials (1000 units/mL concentration, 10 mL and 30 mL vials; 5000 units/mL concentration, 10 mL vials; and 10,000 units/mL, 4 mL vials). These are used when patients need large intravenous doses given quickly, sometimes called “bolus doses” in order to thin their blood over a very short period of time. Patients affected are: patients with kidney failure on hemodialysis; patients undergoing certain types of cardiovascular surgery; patients undergoing other specialized treatments called photopheresis and plasmapheresis and some patients who have blood clots in arteries or veins.

3. Are there other patients who may be treated with heparin that this will not affect? (small dose, flush, etc.)

Heparin is used in many other medical settings, but these do not usually require the higher doses that are of concern with the Baxter product. Other uses which are not of concern include small doses of heparin used to flush, or clear out, intravenous catheters or to prevent clotting in indwelling catheters, and slow heparin infusions to treat clotting in various hospital settings.

I like how they keep saying that this recall will not cause a shortage of Heparin, I think that is untrue.

Hope this helps! Judy

[Leah78]

I called my pharmacist yesterday about the recall and he also had no idea what I was talking about. He looked it up and told me that mine was not involved. I did some searching on my own and apparently it is. I have the Baxter 10,00u/mL 4 mL vials. 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.

Thanks to the person who posted this. I am glad someone is looking out for us since the pharmacies seem to have no clue.

[kadi]

Just a note. The heparin recall of several weeks ago was updated Thurs afternoon Feb 28th to include all Baxter heparin, including the 1cc single use vials I use.
http://www.baxter.com/about_baxter/news_room/news_releases/2008/02-28-08-heparin.html

[GriffsMommy]

I am not saying that what you guys are saying is wrong but I did want to tell you that I had an appointment with my Dr today so I asked the nurse about the recall. She said as soon as they were aware of it they checked to see what it included to make sure it does not affect their patients. They do kits for a lot of their patients and supply the heparin to them directly.

She said that she found out that the recall was only for the prefilled syringes for hosptial use? I also thought that it was weird that I hadn't heard anything from my prescription company since I just got my first mail order instill meds maybe two weeks ago.

So just to make sure, I called the mail order division of my pharmacy coverage and had them look up what they sent me and match it up against the recall list. The pharmacy tech that I talked to said that what they sent me was not one of the batch #'s that was included in the recall. I have used it several times and personally have not had any problems with it. I'm actually planning on doing another one tonight after I put Griffin to bed so I'll be happy to report if it does bother me but both my nurse and the lady from the pharmacy mail order both told me it was safe for me to use it so at this point I'm going to keep on using it unless I start having problems. The woman from mail order had me on hold for a good couple of minutes while she checked the recall list to make sure mine wasn't on it.

[FENNSM]

Christine please be careful. I called baxter myself (if you read the recall notice the number is on it) because my pharmacy had no idea of the recall they told me all heparin vials are recalled. There are no exceptions. I went to my doctor today because I am having the worse flair of my life and she did a rescue instill but left out the heparin due to the recall. She did tell me though that since we put it into our bladder that we most likely won't experience the side effects of the recall compared to someone who gets it injected right into their bloodstream. I do have a question though...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. I would be grateful for any advice

[sugar]

For me, my instills over the last month or so, most of them, have burned. I thought it was the new recipe and stress. When I got a new brand, they dont hurt. So I'm waiting for the pain to calm down.
I recommended to another member to switch pharmacies to get your heparin refilled. I'm not trying to push Walgreens, but I went in the local one and they were more than happy to call the original pharmacy and get it switched over to them. Then they get more business! My local Walgreens did that, had to special order in the heparin and had it in the next morning! I've been pleased w/their service. Just a suggestion of a way to get safe heparin so we can continue treatment.
Medco also told me were looking for a replacement supplier and had no idea when one would be located. I'm not holding my breath waiting on them to get back to me!
Take care!
Annette

[aprilchen]

Has anyone read about the Heparin recall?

At first they were only recalling certain types of Heparin made by Baxter Healthcare Corp. Now it seems they are recalling all of the Baxter Healthcare Corp. Heparin except the large volume parenteral solutions containing 200 Units of heparin per 100 cc in 500 and 1000 cc total volume bags.

Here is the link to the FDA website
http://www.fda.gov/cder/drug/infopage/heparin/public_health_update.htm

Judy
Hi Judy,

I don't know how many people use multiple dose vials of heparin for their instillations, but I use four 10,000 IU for a total of 40,000 IU and a 50mL bottle of Lidocaine plus a crushed tablet of Cytotec, 200 mcg.

Anyway, I don't believe the recall includes the one use bottles. If anyone uses the single use vials and find out differently that there IS a recall, can you please post a message for those of us who use those?

I just went and picked up my supply from the pharmacy and the pharmacist did not say anything about there being a recall. Maybe she did not know???? Does anyone know????

[kadi]

If you read through the letter in the link I posted, which is from the Baxter company itself about the recall, you will see that ALL heparin made by that company is being recalled.

I'd consider the writings in press release by the FDA and the manufacturer of the drug over second hand verbal information. The FDA wrote that it's all recalled and the manufacturer wrote it's all recalled=it's recalled.

The doctor mentioned in the above post may have only heard about the original recall 3 weeks ago, which was mainly hospital supply heparin. That recall was expanded last Thursday to ALL heparin products manufactured by Baxter, including single use vials.

I went to the Baxter homepage & checked the lot numbers on the heparin (10,000 units in a single use 1cc vial) I have at home & it is all recalled.

[Judy777]

Hi April!

Kadi is correct I think where some of the confusion is on this recall is that there were basically 2 recalls on the Baxter Heparin.

The first recall listed specific lot numbers for the recall. See link http://www.fda.gov/oc/po/firmrecalls/baxter01_08.html

The second recall Baxter decided to recall all of the injectable Heparin in vials. The only exception was the heparin pre-mix IV solutions in bags: heparin sodium in 5% dextrose injection and heparin sodium in 0.9% sodium chloride injection. See link. http://www.fda.gov/oc/po/firmrecalls/baxter02_08.html

Here is the link for the recall from the Baxter web site. They also have a phone number for customers to call. Customers with questions may contact the Center for One Baxter at 1-800-4-BAXTER (1-800-422-9837). Representatives will be available twenty-four hours a day, seven days a week.

http://www.baxter.com/about_baxter/news_room/news_releases/2008/02-28-08-heparin.html

I'm not trying to scare the life out of anyone. I hope you guys didn't get the wrong impression. I just thought people needed to be informed to make their own decision about the Heparin. I did not see any posts on the board about it and thought maybe no one had heard about the recall.

I personally used my Heparin and only have 4 vials left. I have not experienced any side effects and I am going to use the last 4 vials for my rescue treatments.

Take care, Judy

[sickofmybladder]

Everyone -

My heparin is manufactured by AmeriPharm - so I was not included in the recall - but for all Baxter manufacturer patients - the recall definately now includes all heparin - including the single use vials - and they are strongly recommending that you return any unused vials - I spoke to my mom about this (she is a nurse) and she said as severe as some of symptoms are (including death) that even though we do not inject through our veins that some of it does get absorbed into our bodies through our bladder.

Also - I received a phone call from my pharmacy today - and now my heparin by AmeriPharm is back-ordered due to the Baxter recall - so please be prepared for this if you are already using another manufacturer - the good news for me is I do have some doses left which I can use - but my pharmacy had no idea how long it would be before I would be able to get anymore since hospitals etc. (and rightly so....) get first priority.

[kadi]

In response to catlover's post, it is not true that there are no other companies that make heparin in single use vials. There are other companies that make this product. The tiny amount of preservatives in the vials may be different, however.
It may be that the wholesaler supplying the pharmacy only carries Baxter; in that case your pharmacy may have to look to other wholesalers or you may have to go to a different pharmacy.

[GriffsMommy]

I actually called both my rx mail order company and my dr's office after I read the link from Baxter stating that it has all been recalled. The pharmacist at the mail order company was very concerned and upset that they didn't know about this. He was very happy that I called and let them know so they could do more research. I told him I know it might not effect me since I don't inject it but I would hate for something to happen to one of their patients that they do send it out to, to use as an injectable. He told me to call Baxter with any questions since that's what his info was showing.
I have to admit that I didn't call them, I called my dr's office to tell the nurse I talked to yesterday about the new info that I received. She said that she was aware that all of the heparin was recalled and they have no idea when anybody is going to be able to get more. She told me that their drug rep told her they couldn't get anymore but because it was not being injected and being put into the bladder instead that it could still be used. She told me that for the office instills which I don't do they will still use the heparin until they run out and then they will change to just doing them with the same amounts of lidocaine and sodium bicarb that they usually use.
She told me it shouldn't be a problem for me to still use it, I did one last night and didn't notice any difference. I actually did it before bed and was able to sleep through the night with it in which is one of the longest times I've ever held it in. She did suggest that if I wanted to make the heparin last longer that I could do 1 ml per instill instead of the 2 ml that I usually use. I just got a three month supply so I'm not sure if I'll need to do that or not. She also said if I didn't feel comfortable with using it then I could just use the lidocaine and sodium bicarb and that would be fine too. She did say if I had elmiron capsules I could empty one into the instill mix and use that instead of the heparin but I haven't been on oral elmiron in months because I couldn't afford it and I'm not even sure if I have the rest of the pills anymore when I stopped taking it but she said that was another option.
Not trying to argue with anyone or ruffle anyones feathers here, just letting you know what I found out and what I was told.

[sickofmybladder]

Christine -

I'm glad that they don't think it would effect our bladders (my mom is a nurse - but in my case she's always a mom first and as a mom - you know that means she always says "well just to be safe" :) )-

I am also trying to "stretch" mine out - I go back to see my uro on March 25th - so if by then I am still unable to get any more heparin - I will bring up the suggestion of adding Elmiron to the mix until things resolve. Meanwhile - the only thing I know to do is reduce the number of times I do them per week - and hopefully it won't set me back too much.

To the other poster about single use vials: I am using single use vials and they are manufactured by AmeriPharm - so there are definately other manufacturers - I am using WalGreens pharmacy if it is any help to you. However, like I said in my previous post - it appears everyone is back-ordered now.

I hope for all of us that this is resolved soon.

[kadi]

Update: new article on heparin recall - If you are considering continuing to use the recalled heparin, please read...

http://news.yahoo.com/s/ap/20080305/ap_on_he_me/heparin_probe

[sickofmybladder]

Thanks for the update Kadi -- Again I hope it's resolved soon.

[aprilchen]

Thanks to everyone who has written on here. I checked and I guess because my Heparin came from the Air Force base, it was not Baxter so I am safe...thank God. I wish all of you the best in getting a supply to replace what you have lost.

Blessings,
AC

[Judy777]

It looks like all of the Heparin is going to recalled. Regardless of the Manufaturer.

I did not see any updates on the Heparin recall on the FDA's website.

I only have 2 vials of Heparin left and tryed to get my prescription refilled. I called two different pharmacies and they both said they are unable to get any Heparin and one of the pharmacies said they called 4 of their suppliers and all of the suppliers said they can not get any Heparin and do not have a release date as to when they can get it. It seems they have recalled it all due to a specific ingredient in Heparin.

I guess my alternative will be to call my Doctor to see if I can just use my Elmiron and use one capsule of the Elmiron along with the Lidocaine and sodium bicarb.

This really stinks!

Judy

[Leah78]

Well, I finally got my pharmacist to listen to me and order some new heparin. It was supposed to come in today but is backlogged. They are hoping maybe tomorrow.

My pharmacist was also pretty much telling me that replacing it isn't really necessary that it is up to me. That the recall was not to the patient level. What the heck does that mean??:cussing: I thought a recall was a recall. I have been having terrible burning and pain with my instills ever since I got this batch of heparin. I have been trying to figure out what was going on. They were helping then bam, they started making me feel a lot worse.

Apparently, there are I think 3 levels of recall. 1.warehouses 2. warehouses and pharms 3. all of the above and patients.
This just doen't make any sense to me.

Has anyone been told or heard of anything similar?

[jen74]

This is concerning. My heperin in from the manufacturer Abraxis. Is this the same as baxter? I am going to call my pharmacy as well though.
Jen

[sugar]

Medco, my mail order pharmacy, called again last night to inform me that they were unable to locate a replacement heparin product in the near future. I also met w/my uro yesterday, Dr Robert Evans in Greensboro, who was well aware of the situation. He suggested that there will likely be a heparin shortage very soon. He told me that if I ran out, that I was to do the following: open (2) 100mg elmiron capsules and mix them w/10cc of sterile water and then mix w/the other regular ingredients of my instill recipe. I want to stress that this was what he told me to do and I'm not suggesting others try it....I recommend anyone else should check w/your doctor as to their preferred course of treatment. But I wanted to share it as the IC specialists are coming up w/some alternative options for us.
Thanks,
Annette

[sickofmybladder]

Annette -

I also see Dr. Evans and am very glad to hear he is aware of this and coming up with alternatives - I was planning to discuss with him at my next appt. at the end of this month -
This may be a silly question - but I've wondered in the past - do you get sterile water from the pharmacy as well?
Thanks!
Becky

[catlover2]

For those of us who use Medco Mail-Out Pharmacy- I talked to a pharmacy supervisor at Medco this morning. Since Medco sent me Heparin that has been recalled, they are responsible for replacing it. Medco is able to get Heparin. However, you have to call Medco to let them know what Heparin replacement is acceptable to you. I can't use Heparin with methylparaben, so I have to use preservative free Heparin or Heparin with a small amount of benzyl alcohol. I also need Heparin that is equivalent to 10,000U/ml. Medco has been able to locate Heparin that works for me. So, Medco Mail-Out users please call Medco and let them know what you need. Please be patient with Medco as they are trying to help thousands of Heparin patients who have been affected by the recall.

[sugar]

Dr. Evans mentioned saline or sterile water. I would think saline would hurt, but that's what he said. I had already bought some sterile water from a durable goods supplier, www.homecaredelivered.com. I've been very happy w/them and I buy my catheters from them as well. Your local pharmacy may have the water too. I bought big bottles, but it doesnt sound like much is needed.
Thanks!
Annette

[jen74]

I use saline solution in my instills and it does not make me worse. That is just me, I know everyone is different though.
Jen

[aprilchen]

Hey Guys,

The Abraxis Heparin is fine. I called the manufacturer itself and spoke with my personal pharmacist at the Medicine Shoppe. Anyway, that is what they said to me when I picked up my monthly supply today. Blessings and I pray that everyone gets their replacements in a timely matter. :-)

[amazing.noodle@]

I was having DMSO for the last few months with the Baxter heparin. The last one I had was 4 weeks ago and it was the most pain I have ever been in after a DMSO. I thought it was because I was already in so much pain when I went in and I had so much anxiety about the catheter. I had the DMSO on a Thursday, by Monday I had to be hospitalized for pain management. I was home alone with my 4 children and couldn't move from the couch. My Mother had to come help me get to the bathroom.I was peeing so much blood that it looked like I had my period. While I was in the Hospital I had an emergency Hydro. I had to use morphine, supositories, pyridium plus, all for the pain and nothing was breaking it. After a few days, my Doc really wanted me to leave because of the insurance issues. I have been on the couch, using a heating pad or hot bath for weeks now. I just went back yesterday and had a DMSO, and today, by miracle I was able to get a few groceries. I am convinced that it was the heparin, my URO, doesn't really know what to think of it.

[shannonrober90]

This Heprin recall gives me the answer to why my installations suddenly got painfull when it us such a pain reliever. The problem is that the urologist that gave me the last 3 in Jan 08 refuses to take this issue serious and said that he would not give me something that is not safe. How can I get the info from my dr to tell me if I received the Heprin that was recalled? My pain is so bad that I am now on Morphin.

[Leah78]

When I went to see my urogyn last week, I also told him about the instills with the recalled heparin making me feel worse. He told me that he thought it was unlikely. Whatever!:cussing: I am so glad to know that my Dr and I are so in tune that he can now feel my pain.:rant: I guess I am just crazy and don't know what I am talking about. Even though after I got a new batch of heparin, they help me again. I also haven't had that horrible burning and pain as soon as I am done doing an instill that lasts for a few days.:loco:

[aprilchen]

This Heprin recall gives me the answer to why my installations suddenly got painfull when it us such a pain reliever. The problem is that the urologist that gave me the last 3 in Jan 08 refuses to take this issue serious and said that he would not give me something that is not safe. How can I get the info from my dr to tell me if I received the Heprin that was recalled? My pain is so bad that I am now on Morphin.

I am so incredibly sorry for everyone who is going through this pain and who are having difficulty with getting good heparin. However, the way to access information on the Heparin recall is to go here: http://www.fda.gov/CDER/drug/infopage/heparin/default.htm

Usually, anything that is concerning medications and recalls is posted someplace on the FDA (Food and Drug Administration). I am happy to say I got a new batch and the military base was able to replace it for me. I'm praying for everyone who needs to get new batches. :pray:

AC

[my3boysmcr]

I just finally got a reply from the urogyn's office where I had my PST followed by a rescue instill as well as 2 DMSO treatments in the fall. I inisisted that I felt horrible after the first one and she poo-pooed me and did the second one. My first rescue instill was following my PST and within 15 minutes of that instill, I had unexplained dizziness that was so bad that I couldn't even move my head without feeling nauseous. The inisisted at the time that there was no possible correlation. The nurse did soe research for me and found that I did indeed recieve the recalled heparin. Their "risk assessment" office has been notified although they still deny any correlation. I did report an adverse event on the FDA webpage with all of the details that I had at that point.

[sugar]

Just a suggestion...for folks who are having difficulty finding heparin, I would suggest Walgreens. I know it's not appropriate to advertise or "push" any particular store, but my local Walgreens here in Richmond has had my heparin every time I've called. I just refilled it again last night and no problems. The brand I get from them is Abraxis, which is manufactured is Illinois. I havent had any issues w/this brand or w/instills w/it. I know they're all over the place. At first, the store had to order it in, but had it by 9am the next day. They've stocked it for me ever since. Hope that may offer some help.
Annette

[jen74]

I also get my heperin from walgreens and it is also made by abraxis. Luckily I have not had a problem getting it so far. My heperin also does not contain any preservatives(alcohol), it is preservative free. The one made by baxter contained alchohol and it really irritated my bladder.
Jen