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Home > Defective Drugs > Heparin
Heparin Recall Lawyers
in Colorado and Nationwide
Heparin is a blood thinner (anticoagulant), used to prevent blood clot formation. It is typically used during kidney dialysis and for patients with heart problems such as:
- Myocardial infarction (heart attack)
- Atrial fibrillation (rapid and ineffective heartbeat)
- Blood clots in the veins
- Heart surgery with a cardiopulmonary bypass
How it started
Baxter International is the company which markets Heparin, manufacturing it from a raw product imported from China. The beginning of the problems that led to its recall in February was a report filed with the CDC (Centers for Disease Control and Prevention) by a St. Louis doctor in January. He had been called in to investigate allergic reactions in two children where having kidney dialysis, and his team pinpointed Heparin as being contaminated.
Within days, 50 more such reports were submitted describing similar reactions in adults on dialysis. By the end of February, that number had risen to 448. The ingredient from China was a substance made from pig intestines. Because of diseases among pigs, the Chinese plant had been using defective ingredients. The FDA has acknowledged that it did not inspect that plant before it began to ship Heparin ingredients to Baxter in 2004. Neither did the Chinese drug agency.
On January 25, Baxter announced that it was recalling nine lots of Heparin vials. On February 29, the FDA announced that Baxter was recalling “all remaining lots and doses of the heparin sodium injection multi-dose, single-dose vials and HEP-LOCK heparin flush products”. This is more heparin products than had been reported defective, but not Baxter’s full array of heparin products.
The contaminant found
On Wednesday this week, March 19, 2008, federal drug regulators announced that the heparin contaminant was an unapproved ingredient that mimicked the real one. It’s a chemically altered form of something that many Americans know: chondroitin sulfate, which is taken to treat joint pain (arthritis). The FDA officials are not saying whether this contaminant was inserted purposely or by accident. They suspect it was used as a cheap filler.
The chain of supply went like this:
- Unregulated Chinese family workshops make crude heparin from pig intestines
- They sell it to two companies in China called consolidators
- These companies sell it to Changzhou SPL, the Chinese plant that in turn sells it to Baxter.
Baxter’s tests have showed that the heparin supplies were contaminated before they got to the Changzhou plant. So their investigators are now focused on the two consolidators, although so far, they have been denied access to both the consolidators and the workshops. Nor has the FDA been given access. All heparin entering the U.S. is now being stopped and tested.
Symptoms of the Heparin Reactions
- Stomach pain, nausea and vomiting
- Diarrhea
- Decreased blood pressure
- Chest pain and a fast heart rate
- Dizziness and fainting
- Shortness of breath
- Flushing and sweating
- Headaches
- Swelling throat and difficulty with opening the mouth
Some of the symptoms are life-threatening. Twenty-one people have in fact died after being given Heparin, though the causal relationship is not yet clear.
If you or a loved one has been given Heparin and has experienced any symptoms like the ones listed above, be sure and talk to the doctor. Please also feel free to call or email us for a free consultation. Our defective drug attorneys are focusing on this Heparin recall, and are accepting new cases in all 50 states.
