On January 9, CDC investigators notified the FDA, which sent investigators to inspect Baxter's manufacturing plant in Cherry Hill, N.J., where they found contaminated doses of blood thinners containing heparin. Baxter then voluntarily recalled nine lots of heparin—about 10 percent of the company's annual production of the blood thinner—and the FDA warned health care providers to stop administering the drug.
U.S. health care facilities had been purchasing more than one million multiple-dose vials of heparin-based blood thinners monthly, half of which were made by Baxter. Most of the remaining heparin products used in the U.S. are distributed by American Health Packaging in Valley Forge, Pa; APP Pharmaceuticals, LLC, in Schaumburg, Ill.; B. Braun Medical, Inc., in Bethlehem, Pa.; Covidien (formerly Tyco Healthcare) in Mansfield, Mass.; Hospira, Inc., in Lake Forest, Ill.; and Medtronic, Inc. [[http://www.reuters.com/article/healthNews/idUSN0730155620080507]], in Minneapolis. American Health Packaging, B. Braun, Covidien and Medtronic recalled heparin-based products from March through May due to concerns that they might be contaminated. Baxter was the hardest hit: Physicians reported about 350 adverse events from Baxter's heparin products in January and February alone, compared with fewer than 100 reports in all of 2007, according to the FDA. APP increased its production capacity and has taken over as the major supplier of the U.S. market.
Most of the problems involved dialysis patients who had received high intravenous doses of a type of heparin (high molecular weight heparin) that thins the blood for about an hour while they are undergoing treatment. Another type—low molecular weight heparin—thins the blood for hours longer than the high molecular weight variety and is more likely to be used on patients staying in the hospital (to prevent clots while bedridden). There are some synthetic forms of low molecular weight heparin, such as sanofi–aventis's Lovenox, but currently there is no synthetic high molecular weight alternative on the market.
Baxter had called Linhardt to tap his expertise and to help track down the source of contamination. He agreed to share his findings with FDA officials, who soon began calling him for daily updates and to get his take on what they found. "Often the FDA suggested experiments that I should try in my lab," he says. "Apparently, the FDA was using my lab to confirm and validate results that other laboratories were reporting."
On the trail of a killer
Within weeks, the FDA—working with Linhardt as well as research teams at the Massachusetts Institute of Technology (M.I.T.) and Washington University in St. Louis—had narrowed the list of suspected contaminants to oversulfated chondroitin sulfate (OSCS), because it mimics heparin's capabilities and appears to be heparin when tested in the lab. Although OSCS is based on chondroitin sulfate (prepared from animal cartilage or beef trachea) that many people take as an anti-inflammatory to treat osteoarthritis, OSCS has the opposite effect, activating immune system enzymes that cause inflammation as well as a drastic drops in blood pressure. The question: What was it doing in batches of heparin, where it would have no purpose other than to increase the volume, driving up sales of an artificially pumped up product, Linhardt says.
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8 Comments
Add CommentNOT SURPRISING... when the U.S. continues to outsource vital industrial/medical processes. Yes, we "save a few bucks" on the front end with their cheap labor... then pay dearly when undetected toxins or unsafe products are disseminated in the marketplace among us.
Reply | Report Abuse | Link to thisLow molecular heparins (eg Lovenox) are preferred for their safety, ease of administration (do not require lab monitoring of clotting parameters) and the fact that over the long-term do not cause osteoporosis or a low-platelet count.
I really don't see a realistic market for completely synthetic "high molecular weight" heparin... but then again, if I were of the PORCINE persuasion, I would certainly hope for a breakthrough.
BTW, I quit eating pork (and lamb much earlier) due to the inhumane conditions of these massive, corporate hog farms... to say nothing of the incredible runoff of pollution to nearby streams. Furthermore, pigs are smarter than your pet dog.. and certainly more intelligent than a early toddler.
Cheers!
How far back does the Heparin recall go? My mom had heart surgery in August 2007, was given Heparin, never got off respirator, had hypotension, kidney failure, and died a week later.
Reply | Report Abuse | Link to thisI do not know how long the recall goes but I seen an add on T.V. about this subject. A lawyer was taking wrongful death suits. (This is why I am at this site right now). My brother-in-law is right now taking this drug and I was trying to find out as much as possible. I am sorry I do not recall the lawyer's name but I am sure if you put heparin lawsuit in any search engine I am sure you will find it. They probably could anawer your questions. I am sorry for your lose and may God be with you.
Reply | Report Abuse | Link to thisI had been given Heparin in November of 2008 because of blood clot in lower leg, was given it 3 times and had to be taken off because was causing more clots and had to have leg amputated just above knee and my whole life has changed to the point that I cannot do any of the things I use to do. Because of this it has caused many other problems in my families life. The TV adds telling about recall was on TV at the same time this was all going on, and my husband asked doctors about it and they told him not to worry about it.
Reply | Report Abuse | Link to thisIs anyone aware of birth defects in children, i.e., limb abnormalities, whose mothers took the Lovenox injections during pregnancy?
Reply | Report Abuse | Link to thisI was in the hospital for 20's days due to having a PE! They had me on HeParin for all that Time and then the Nurse hurried in my room and cut off the HeParin Machine and never tolod Me Why?! But Now I see Why?! Here it is 2 1/2 years Later and I been In And Out the Hospital Complaining about Pain, Pain, Pain And More Pain! Come to find out it did Heart and Muscle Damaged!!!!! But I Thank God I'm Still AliVe!!!! GOD IS GOOD!!!!!!!
Reply | Report Abuse | Link to thisI was in the hospital for 20's days due to having a PE! They had me on HeParin for all that Time and then the Nurse hurried in my room and cut off the HeParin Machine and never told Me Why?! But Now I see Why?! Here it is 2 1/2 years Later and I been In And Out the Hospital Complaining about Pain, Pain, Pain And More Pain! Come to find out it did Heart and Muscle Damaged!!!!! But I Thank God I'm Still AliVe!!!! GOD IS GOOD!!!!!!!
Reply | Report Abuse | Link to thisI was in the hospital for 20's days due to having a PE! They had me on HeParin for all that Time and then the Nurse hurried in my room and cut off the HeParin Machine and never tolod Me Why?! But Now I see Why?! Here it is 2 1/2 years Later and I been In And Out the Hospital Complaining about Pain, Pain, Pain And More Pain! Come to find out it did Heart and Muscle Damaged!!!!! But I Thank God I'm Still AliVe!!!! GOD IS GOOD!!!!!!!
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