Parker Waichman LLP

Heparin Reactions Observed in Germany as FDA Expands Tainted Drug Investigation

  Heparin Reactions Seen in Germany. Heparin has caused serious, life-threatening reactions among dialysis patients in Germany similar to those seen among people in the US treated with Baxter Heparin. That announcement, made yesterday by the US Food & Drug Administration (FDA), has raised concerns about the true extent of the public health crisis presented […]

Heparin Reactions

 

Heparin Reactions Seen in Germany. Heparin has caused serious, life-threatening reactions among dialysis patients in Germany similar to those seen among people in the US treated with Baxter Heparin.

That announcement, made yesterday by the US Food & Drug Administration (FDA), has raised concerns about the true extent of the public health crisis presented by tainted Heparin.

At the same time, the FDA is expanding the scope of its Baxter Heparin investigation, and is trying to determine whether the drug was deliberately contaminated in China with a fake ingredient.

Baxter International began recalling Heparin after the FDA reported that, since the end of 2007, it received about 350 reports of health problems associated with Baxter’s multiple-dose injectable Heparin; 40 percent were deemed serious and four resulted in death.

Reactions included difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that—in some—was life threatening. Baxter stopped selling multiple-dose Heparin in early February, and the FDA has advised doctors to prescribe alternatives.

Baxter recalled all of its remaining Heparin products on Feb. 29

Baxter recalled all of its remaining Heparin products on Feb. 29, after the FDA determined that other suppliers could make up for the lack of Baxter Heparin. By that time, Baxter Heparin had been implicated in more than 400 adverse reactions and at least four deaths. Now the FDA is saying that it is investigating 19 deaths possibly tied to Baxter Heparin.

In Germany, the FDA said there had been similar reactions to Heparin among dialysis patients in that country. The Heparin involved in the German reactions is made by the German company Rotexmedica. The FDA did not say where the German company gets raw ingredients for its Heparin, but said it ruled out Scientific Protein Laboratories, which uses a Chinese supplier.

Earlier this week, the FDA said an inspection of the Chinese plant that makes the ingredient for Baxter had turned up serious deficiencies. The FDA said there have been less than 100 incidents in Germany and no deaths.

Yesterday, the FDA said it had found significant quantities of a chemical that looks like the key ingredient in the drug and was apparently substituted for it.

All of the ingredient came from China. Dr. Janet Woodcock, the FDA’s deputy commissioner said the agency is trying to determine if the contamination with the counterfeit ingredient was deliberate. Despite this discovery, the FDA has not yet definitively tied this fake ingredient to the adverse reactions.

Because of the events in Germany, the FDA yesterday cautioned all Heparin manufacturers of the need to conduct specialized nuclear magnetic resonance spectroscopy tests to ensure a safe supply of the blood thinner, derived from an enzyme found in the mucous lining of pig intestines.

Need Legal Help Regarding Heparin Reactions?

The personal injury attorneys at Parker Waichman LLP offer free, no-obligation case evaluations. For more information, fill out our online contact form or call 1-800-YOURLAWYER (1-800-968-7529).

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
Positive: Responsiveness I was always kept in the loop regarding my claim. Parker Waichman's Stacy Candalino provided exceptional representation for me during my claim process. She was always quick to respond to my inquiries and address my urgent concerns. I am so thankful for all Stacy did to help me through the process.
Donna Battle
3 years ago
5 Star Reviews 150
Very professional and always answer question rapily very helpful
Lori Napper
4 months ago
5 Star Reviews 150
Parker Waichman excellent law firm. They have the best customer service. They always answer my questions. Thanks to Jorge Peniche for always helping me. Create job Parker Waichman!!!
Irma Perez
4 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038