Contaminated Heparin Lawyers
Personal Injury Lawyers - Representing People Nationwide
Contaminated Heparin in Association with Medical Devices- In an investigation following a February 2008 recall of heparin sodium for injection, the Food and Drug Administration (FDA) identified a previously unknown contaminant in the blood-thinning drug. In a follow-up July 2008 advisory, the FDA revealed that contaminated heparin had also been found in association with certain medical devices, some of which had also been recalled. The FDA is continuing to investigate the situation.
Heparin is an anticoagulant (blood thinner) that makes an anti-clotting protein in the body work better, and is usually given before certain types of surgery to prevent and treat blood clots in arteries, veins, and the lungs. Certain medical devices and diagnostic products contain, are coated with, and/or are manufactured using heparin. Some of the devices that may be affected by the heparin contamination include:
- Heparin solutions in pre-filled syringes and lock flush solutions in vials
- Certain filters, oxygenators, cannulae, and reservoirs used in cardiopulmonary bypass procedures
- Certain vascular access, retransfusion, drainage and thermodilution catheters and oximetry probes
- Certain vascular grafts and stents
- Some assisted reproduction media devices
- Certain In-Vitro Diagnostic media (IVDs) and related devices
Click here for a list of medical devices that may contain or be coated with heparin.
Click here for a list of products that have been recalled.
Concern that some heparin in the US may be contaminated was first raised after the FDA learned about an increase in the number of cases of severe hypotension and serious allergic-type hypersensitivity reactions in association with the use of intravenous bolus injections of heparin sodium manufactured by the Baxter Healthcare Corporation.
The FDA has identified the previously unknown contaminant in the heparin as oversulfated chondroitin sulfate. The contaminant can lead to many of the observed symptoms, including low blood pressure, shortness of breath, and abdominal symptoms, which supports its association with the contaminated heparin's adverse effects. The FDA, however, does not yet know how the heparin became contaminated. The agency is continuing to investigate.
If you or a loved one has been injured by the contaminated heparin or a medical device that contains, is coated with, and/or was manufactured with the contaminated heparin, you may be entitled to compensation. To find out, contact a pharmaceutical injury attorney today.