Several contaminated batches of this anticoagulant can cause severe allergic reactions, or catastrophic injury or even death!
Background Information on Heparin
Heparin is a powerful anticoagulant used in surgeries as a blood thinner to help prevent formation of clots in blood or is given as medication to patients who have a higher tendency of blood clot formation due to certain medical conditions. Heparin can be administered either directly into the blood stream through an IV or as an injection under the skin. No oral form of Heparin is currently available. Heparin has many uses, but almost all of them are related to preventing formation of blood clots. It is derived from the tissues of animals such as pigs and cows. Heparin is invaluable for patients who are on dialysis and sells at the rate of more than 100,000 vials a day; it has been in use in the United States for more than 70 years.
Heparin General Side Effects
Extreme care has to be taken while administering Heparin as it can cause some serious side effects if not administered in the right dosage. The main side effect of Heparin is bleeding and is therefore important that physicians monitor the blood count of patients to ensure that blood counts remain stable during treatment.
In some cases, spontaneous bleeding from several places in the body like gums and mouth, stomach, open wounds, etc., have also been observed as side effects and at times blood transfusions are required to replace the blood lost.
Another potentially lethal side effect is HIT (Heparin Induced thrombocytopenia) — a condition where Heparin induces the body to produce antibodies against its own platelets. In such cases it could cause spontaneous formation of large blood clots and complicate the situation rather than acting as a blood thinner. This condition could block the flow of blood to blood vessels and cause damage to vital organs such as kidney, brain etc.
Heparin Contamination and Recall
Starting late 2007, patients receiving Baxter™ Heparin started to show allergic reactions to the drug just after receiving it. As reports of these reactions kept increasing, Baxter International, the company which manufactures a brand of Heparin, recalled certain batches of the drug. In 2008, an advisory was issued by FDA, to the medical community to stop using the blood thinner after they had received around 300 complaints about the drug. The FDA asked Baxter International to stop production of the drug and recall all the products from the market after 21 deaths in a month due to the use of Heparin were reported. In the same year B. Braun Medical Inc, a supplier of Heparin in Canada started recalling their Heparin solution and another company, Health Canada announced that their products were tainted. Braun recalled thousands of units that were distributed across Canada, Australia and United States.
After the FDA investigated the issue, it was found that the raw ingredients used for the manufacture of the drug came from China. This ingredient was supposedly contaminated with Chondrotin sulfate, a widely used over the counter drug for joint pain. When Chondrotin Sulfate is altered it mimics the blood thinning action of Heparin. It is still not clear if this was done deliberately or by accident. The FDA admitted that it had flouted it own rules and had approved the plant in China which was manufacturing this ingredient without inspecting it.
The side effects which were reported due to this contamination included breathing difficulties, excessive sweating, vomiting, chest pain, fainting and, dangerously low and continuously dropping blood pressure which could lead to shock or even death.
Experienced Heparin Lawsuit Attorneys Can Help
If you or anyone in your family has undergone a surgery or dialysis where Baxter Heparin has been administered and have suffered from allergic reaction or other related side effects including death, please call (210) 888-8888 to speak with our Baxter Heparin injury attorneys immediately. You may be entitled to legal compensation and can greatly benefit by contacting the right lawyer.
Our San Antonio dangerous drug attorneys are equipped with the necessary expertise and years of experience in handling prescription drug cases to offer you the best support.