The U.S. Food and Drug Administration (FDA) issued a drug safety communication regarding the labeling of the anticoagulant (blood thinner) Heparin. Previously, confusion over the dosage contained in Heparin products could cause over- or under-medication in patients, which could lead to life-threatening side effects.
What Is Heparin and What Is It Prescribed For?
Heparin is a naturally occurring chemical in people. It is one of the oldest drugs in use, predating the FDA’s existence. Named for the Greek word for liver, heparin prevents blood clot formation by binding to specific cell receptors involved in the clotting process. It does not break up clots, but it can help other bodily chemicals do so. It is sold generically as an injectable solution.
Heparin Side Effects Might Result From Under- or Over-Dosing
On December 6, 2012, the FDA issued a drug safety communication stating that it was requiring a label change in the following heparin products: Heparin Lock Flush Solution, USP (United States Pharmacopia); and Heparin Sodium Injection, USP. Going forward, all containers must show the total drug strength on the container and then the drug strength per milliliter (mL). The goal is to prevent medication errors due to caregivers and users having to manually calculate the total dosage themselves. Because the products are not being recalled, containers with the older labels will appear alongside newer ones starting May 1, 2013, and lasting until the older versions are sold out.
Contaminated Heparin Products Have Injured Users
According to the FDA, in February 2008, some Heparin users suffered serious injuries or died due to contaminated Heparin products manufactured by Baxter Healthcare Corporation in China. Other Allergic or hypersensitivity reaction symptoms caused by the contaminant include:
- Low blood pressure
- Angioedema (swelling in the extremities)
- Shortness of breath
- Abdominal pain
Baxter Healthcare initiated a Heparin recall of its products. The FDA is continuing its investigation of the contaminant, and it found contamination in other medical devices that are associated with Heparin, such as catheters. More information can be found on the FDA’s Web site.
As a result of the contamination, many people have filed lawsuits against Baxter Healthcare. Hundreds of Heparin lawsuits have been filed in Cook County Circuit Court in Illinois, and one ended with a $625,000 jury award for a plaintiff.
RLG’s Heparin Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The Heparin lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Heparin lawsuit on your behalf if necessary. RLG will also keep you up to date on any Heparin class action lawsuits, additional FDA Heparin warnings, and Heparin FDA recall announcements. If you or a loved one took Heparin and believe it caused an injury due to a mislabeling or contamination, contact RLG today.