Partial Heparin recall issued due to risk of serious adverse reaction
Baxter Healthcare has issued a nationwide Heparin recall for nine batches of their 1,000 units per millileter Heparin Sodium Injection in multi-dose vials. Over the past two weeks, Baxter has received over 100 reports of unusual alergic reactions, and at least one death which could be linked to the recalled Heparin.
>>FDA ALERT: Baxter Heparin Recall
Heparin is a blood thinning drug which is often used for patients undergoing open-heart surgery, vascular surgery, dialysis and a number of other medical procedures. There have been reports of patients experiencing severe alergic-type reactions to the apparently bad batch of Heparin sold by Baxter Healthcare. Some of the unusual reactions reported in patients who received the Heparin Sodium injection have included:
- Abdominal pain, Chest pain or stomach discomfort
- Burning sensation or restlessness
- Diarrhea, nausea or vomiting/retching
- Flushing, Dizziness and Headaches
- Drug ineffectiveness
- Pain upper middle part of the stomach (Dyspepsia)
- Shortness of breath or difficulty breathing (Dyspnea)
- Redness of the skin (Erythema)
- Increased sweating or perspiration (Hyperhidrosis)
- Reduced sense of touch or sensation (Hypoesthesia)
- Abnormally low blood pressure (Hypotension)
- Increased production of tears (Lacrimation)
- Loss of consciousness
- Malaise, Pallor or Heart Palpitations
- Tingling, pricking or numbness of the skin (Paresthesia)
- Swelling of the throat (Pharyngeal edema) or Thirst
- Rapid beating of the heart (Tachycardia)
- Lock jaw (Trismus)
- Unresponsiveness to stimuli
On January 17, 2008 Baxter sent a recall letter to their customers, wholesalers and distributes who received the affected Heparin Sodium 1000 unit/mL for injection. Although the letter indicated that they had not received any reports involving fatality, there are now reports out of Florida that a heart surgery patient died as a result of unusual postoperative blood clots on January 18th when the Heparin injection was apparently ineffective.
The Heparin recall applies to certain vials with expiration dates between September 2009 and November 2009 from the following Lot Numbers: 107054, 117085, 047056, 097081, 107024, 107064, 107066, 107074, 107111. These Heparin vials should not be used and should be segregated from other vials.
There does not appear to be any connection between the Baxter Heparin recall and a recent recall of prefilled Heparin Syringes. The Heparin syringe recall, which was expanded last week to include both prefilled Heparin and Saline syringes, was issued because the syringes may be contaminated with Serratia marcescens bacteria.
BAXTER HEPARIN RECALL LAWSUITS
The product liability lawyers at Saiontz & Kirk, P.A. are reviewing potential Heparin recall lawsuits for individuals who have recently experienced a severe reaction after receiving an injection of the blood thinner. To determine if problems experienced by you, a friend or family member may have caused by the recalled batch of Heparin, request a free consultation.
21 Comments • Add Your Comments
George says:
I had open heart surgery at Florida Hospital on 9/21/2007 and while still in the hospital a life threatening adverse reaction to Heparin causing blood clots in my legs, groin and lungs. This complication resulted in a 17 day hospital stay and an unduly long, painful recovery from surgery. I have no issues with Florida Hospital or the Doctors who saved my life, but I have always wondered why this happened. I did not have a reaction to Heparin in January, 2002 when I had angioplasty in OKC, OK.
Posted on January 29, 2008 at 9:52 am
Jerry Rogers says:
My Dad had Aortic anurism repair in August, 2007 After surgery, the Doctor informed us Dad had allergic reaction to Heparin, which caused clotting instead of thinning. Two days after surgery, they had to perform emergency surgery to clear blockage in left leg. Then had to amputate part of left foot. Started dialysis after fifth day, and has been on dialysis and ventilator ever since. Dad has shown no sign of communication, and in Dec. was transferred to LTAC because hospital said they could not ween him from ventilator. To date, his condition remains the same. On ventilator, dialysis, and no sign of communication. Doctor at LTAC said there is nothing they can do for him. The hospital back in August tried to engage palative team to have him pulled off life support, but the family had hope for some miracle. Now it appears there is no recovery for some, from this heparin reaction.
Posted on February 3, 2008 at 6:57 am
Jean says:
In Dec of 2007, husband admitted to hospital with pneumonia and on going issued with emphysema–released to a nursing home on Jan 4, 2007 for intravenous medication–also received heprin—–on Jan. 16 2007, admitted to hospital with small heart attack, and several blood clots in legs and lung. Due to his lung condition, husband was a non-surgical canddate, so vascular surgeons operated on his using a local anesthetic to break up blood clots in legs, or possible amputation would have been necessary ) he is a non surgical candidate remember)- The diagnosis was “heprin induced thrombosis with thrombocytopenia” Because of this husband has been in a nursing home since that time, with the exception of one month,
I am attempting now to find out if the recalled heprin had any bearing on this.
Posted on February 24, 2008 at 2:11 pm
raquel says:
I am a dialysis patient who have experienced a reaction due to heparin and it is now a huge concern about what I have been through lately.
I am interested in what matters I can take concerning this matter of heparin recall.
Posted on March 7, 2008 at 2:01 pm
TRACY says:
I AM A 33 YEAR OLD FEMALE THAT HAS NEVER HAD HEART PROBLEMS..WELL TILL NOW. I RECEIVED THE CONTAMINATED HEPARIN THROUGH A PORT I HAD FOR INTRAVENOUS MEDICATION FOR MIGRAINES..THAT IS IT.
AFTER RECEIVING THE HEPARIN I HAVE HAD TO HAVE 4 ANGIOPLASTIES FOR A RECURRENT STENONSIS. I HAVE BEEN VERY ILL. I AM VERY ASHAMED OF MY LOCAL HOSPITAL CHRISTUS ST MICHEAL I TEXARKANA TEXAS FOR NOT COMING FORWARD WITH THE FACT THAT THEY DID USE THE CONTAMINATED HEPARIN. IT WAS NOT THERE FAULT FOR HAVING OR GIVING THE MED BUT IT SHOULD BE THERE RESPONSIBILITY TO TELL THE PATIENT WHO RECEIVED IT. ONLY THROUGH MY PERSISTANCE OF ABOUT THREE MONTHS DID I FIND OUT. AND FROM THE ONLY ONE AT THAT HOSPITAL WITH A HEART DR. FINLY KUDOS TO HIM…AND TO EVERYONE ELSE OUT THERE WHO HAS BEEN THROUGH THIS MAY GOD BLESS YOU!!!
Posted on July 29, 2008 at 3:58 pm
Linda says:
My dad had a reaction to heparin, which the doctors nicknamed HIT, after open heart surgery in September 2004, which resulted in a stroke. After less than a month it was obvious that he was going to lose much of his left hand and most likely be blind if he lived. Due to the fact, he was so sick from all of this, he remained in the hospital for 6 1/2 months and from that extended hopital stay acquired one major infection after another. Even though the heart surgery (4 by-passes) was successful, the heparin left him to sick to recover. He still passed away in March 2005. Only recently did I learn that there was a problem with heparin that other people were experiencing. Up until the time of his heart attack, he was a vital, active, farmer and he is deeply missed. I feel if the heparin had not have caused the stroke, he would have recovered from the heart attack.
Posted on December 17, 2008 at 2:12 pm
Louise says:
My mom was on dialsys for about 7 years and she had lots of trouble. In Nov. of 2006 she was put on home dialsys,it was going very well. She had to take the heprin and never had any trouble with it , then in Nov. 2007 she started going down hill. She just got worse and worse. Then in Feb. 2008 she passed away. Two weeks later we got a lletter from Baxter for her to stop taking the heprin cause it was contaiminate. It was like losing her all over again. She didn’t dersever to die in all that pain.And saying that I think they should have to pay dearly.
Posted on March 2, 2009 at 12:12 am
Ms. B. Williams says:
My mom went through emergency due to abdominal fluid needing to be drained. She was diagnosed months ago with cancer of the uterus. Prior to going in to the hospital, for drain, she was very active and lively and quite independent, she just had fluid on the abdomen that was uncomfortable. This would have been the first time she was drained or experienced this fluid. While in the hospital room the nurse administered a blood thinner. She was asked why and we were told it was to help keep her blood from coagulating. My mom had never had a problem with her blood like this and she was only going for a fluid drain. A few days later my moms health took a turn for the worst, it was sudden. She no longer was active and independent and her body weight was diminishing rapidly. I obtained copies of her blood work and I saw where it read, “no hemolysis present” and her potassium had gone from 4.6 to 6.0 during a 4 day stay in the hospital, and again she was only there because she was wanting to be drained of the uncomfortable fluid. This was the first time she was drained and she had never experienced any sort of pain etc… after her surgery in 2008, 10/13. We switched doctors…… and shortly after mom was experiencing shortness of breathe and went through emergency. The doctor said they wanted to check her for blood clots and used, “heprin”. She was admitted into the hospital for 2 weeks and 2 days prior to her discharge we were then told she had an allergic reaction to heprin and it has caused her platelets to drop resulting in possible clots, bruising etc…and her blood pressure is unusually low.
Posted on April 30, 2009 at 1:01 am
Lisa says:
I have recently used heparin to avoid clot during pregnancy due to antiphospholipid disorder. After using for 2 weeks I developed a terrible burning rash, hives and swelling which are still active at my injection sites a week after discontinue of use. I miscarried as well which makes me wonder if the medication was ineffective or contaminated- long after the recall.
Posted on May 12, 2009 at 2:26 pm
Rosa says:
My dad was a healthy 75 year old man, who was never hospitalized nor had any type of procedures done in his life. We were told that he needed a double valve replacement so surgery took place in June 2007. The surgeon indicated that the surgery would take 5 hours. Our worst nightmare happened. After five hours no doctor. It took 10 hours later that the doctor and anesthetic came to talk to us. They told use that the surgery went well, but onces they started stitching him up “all hell broke lose”. They said the could not stop the bleeding, blood after blood after blood, but everything kept coming out. The doctor did give us 24 hours grave condition. After they told us that he was allergic to heparin. The doctors sponged him and the next my dad went under the nife to see if the bleeding stopped. It did, and they gave him 24 hours grave condition. In ICU he was started on dialysis. His kidney never picked up and now is on dialysis.
Posted on June 12, 2009 at 11:58 am
mark says:
my wife was given 10000 units heparin and she had all the side affects.two days later she past away.
Posted on August 8, 2009 at 7:32 am
sandra says:
My Mom is going tho hell from a heparin side affect …….. HELP what do i do ?????? I dont want to lose her but now it shut her kidneys down so she is on dialysis and they want me to take her off of it …bc her blood pressure and her heart rate is getting bad ….. HELP she was a healthy 72 year old who 1st went in for a UTI and then 3 wks later when baack in w bllod clots in legs lose one leg already …. and going down hill ….
Posted on February 16, 2010 at 12:35 am
Deborah says:
We had survived Hurricane Katrina in Aug of 2005 our home and town of Bay St Lous Ms was destoyd. We came to Florida in Oct of 2005. I had been having stomach ache on and off and thought due to our loss my stomach was just acting up. It got worse and when I went to local emergancy room in Jan of 2007 I was sent for a heart catherization and given the drug heparin. I woke up 8 days later in ORMC I had been airvaced and told I had an allergic reaction to heparin instead of thinning blood it coaguated my blood and I had to have a triple by pass I had pulmanary edema and had to have a defib pacemaker put in. I have had the back of my heart repaired and 7I stents. I thank God I am alive and thankful to the hospitals and drs who saved my life after I was given a terrible drug. my life is so drastically changed. I look for the positive dailly and pray no one else has to experience this nightmare. I was told I died 2 times so I am tahankful for the team I had after the fact.
Posted on August 30, 2010 at 5:57 pm
Donald says:
In had chest rash problems, vomiting, diaherea in the middele of 2009. My HMO for two months (a jerk) when I visited with him gave me an address etcx., to go to for some analysis. When a montgh later I arri8ved at this business they didn’t have the appointment called into them as required and my HMO said we will reset another one to me at this place. I on my own volition checked into Kaiser. They came up with all kinds of conclusions and facts that were always inaccurate. They did put a catheter in me with no reason or explanation even when IO asked why? At the hospital i was given Heparin. I didn’t know this until today ( 09/05/2011) when I received my files from Kaiser and Riverside Community Hospitals. It shows, among other things (fraud, lack of consent for stents or anything, unknown doctors who I have never met before who act like they are my legal providers, and stgents put in without any urgency to do so but for the many doctors involved including the HMO and his “foreign” doctor friends who all were bent on fraud and to make money)
My HMO in the RCH hospital notes of record show that he and his “friends” knew that I was on Heparin. He then gave a written instruction to everybody and to include the hospital pharmacy not to give me any heparin any longer. This I discovered today! However, they still did continue to give me Heparin at Kaiser then RCC.
Even at RCC hospital the doctor asked me when she was giving me Heparin “how many of these have you had so far?” I said, as a guess, about eight so far and this will be the ninth.
I never had a singleinformed consent and they just figured that a 77-year old man (me) has no idea as to what is going on. I didn’t but when I got the records and am rading them now the fraud committed between all the hospitals and their doctors is mind-boggling. When after five days I left RCC I even got a prescription for Heparin that I got from a drug store in Palm Springs, California. It was a “loaded” heparin needle (all five of them over five days).Of course what I did wa to have the needle shot into my stomach area as discussed in the vacating of that hospital. If you want to see frauds let me know and I can send you over 700 pages just from Kaiser who also caused me to have bladde problems that I didn’t have going in and when leaving and one has to take a tst for urination.
I have the records on a disc from the RCC 727-pages and copies oif documents from Kaiser that are just over about 300-pages. I can’t believe that for something that was simpkle initially that these doctors worekerdc out a conspiracy to commit and did commit fraud on me in many ways as sghown in the documents totalling noiw 1000 from the hospitals and a few thouand from my saving of things that just may come inhandy if needed. Oh, yes, finally before I went to see the HMO doctor there was wo before him that I had seen just on physicals. I flew right through them with noithinhg wrong with anything having to do with me. Even the two separae doctors at the HMO place asked me how do I stay in such good shape? Oh, yes, they are gone and when my HMO doctor was forging the documents of my file I said “that is fraud what you are doing.” He said nothing! The administrator in the frontoffice said to me that the paperworlk (files) on me ae with Dr. Pengson my HMO. When I asked him how I can get copies of them he said to ask the manager out front. Then she said let me look around for them in that they appear to be misplaced. What was meant to be aid “we are going to mke the prior records disappear!”
I changed my HMO doctor and who wouldn’t
Posted on September 5, 2011 at 11:42 pm
MHILAIRE says:
My mom was killed in 2009 after being given Heparin LOT P235333 EXP DEC09
intravenously…
I asked what are they doing, my mom said she didn’t want anything, nothing– they said she has to have this… she says NO, they don’t listen… next thing I see is on her monitor her blood pressure goes from 120/70 and rises up and up and kept going over 226/105 and kept going it was like her heart burst out of her chest, We had to put her into a coma because of the pain, she was dead the next day. Thanks Baxter 🙁 No amount of money can fix this. This pain never stops for me.
Posted on July 26, 2012 at 1:51 pm
Wendy Q says:
My husband recently went in for day surgery in June 2014. He was given Heparin and while in recovery nearly died. He had two blood clots that went loose. One went through the heart and the other went through the lung further collapsing part of his right lung. He spent a further five days in hospital because be had to get his lung working. He is still having some difficulty breathing.
Posted on August 28, 2014 at 5:35 pm