Heparin Contamination Side Effects

Contaminated bloodthinner connected with potentially fatal side effects

Recently, the FDA announced the identification of a contaminant in Heparin, a bloodthinning drug distributed by Baxter Internation Inc. The contaminant is oversulfated chondroitin sulfate, a chemical that does not occur naturally. The FDA is currently investigating how the Heparin became contaminated.

Hundreds of adverse events, including 19 deaths, have recently been reported to the FDA in connection with Baxter's Heparin. Adverse reactions to Baxter's Heparin may include: refractory hypotension leading to organ damage, organ failure, shock, and death. Baxter began recalling its Heparin products in January and expanded its recall to most Baxter Heparin products in February of 2008.

How is Heparin used?

Heparin is commonly used before certain types of surgery, including coronary artery bypass graft surgery, and in kidney patients before they undergo dialysis. In some situations, Heparin treatment is initiated using a high bolus dose given directly into the bloodstream (intravenously) over a short period of time, usually less than one hour. The reported adverse events occurred in patients who were given Heparin in this form of administration. There are many other uses of Heparin involving lower doses or administration over a longer period of time; adverse events have not been seen with those uses.

Injured by Heparin?

If you have or a family member has been injured or suffered serious side effects from Heparin bloodthinner, you may be entitled to compensation from those responsible. At Arnold & Itkin LLP, our attorneys have the knowledge and experience to take on large pharmaceutical corporations like Baxter and hold them accountable for their actions.

For a free consultation with an experienced attorney, contact a medical injury attorney online or phone Arnold & Itkin LLP toll free at 1-866-222-2606.

Heparin Questions & Answers

Question #1:
What is Heparin?

Heparin is a blood thinner that comes in either vials or in syringes. The drug is often used during surgery, kidney dialysis or while a patient is bedridden to thin a patient's blood. A reason a doctor would want to thin a patient's blood is to prevent clotting (for example, during an open heart surgery, you wouldn't want blood to clot during the procedure). Heparin is also used as a "flush" product to inject into an IV line to clear the line—it removes blood clots from the line.

Question #2:
Why is Heparin a problem?

In a nutshell, the drug was contaminated during the manufacturing process. This was thought to have first occurred in September 2007, however, research is still ongoing so do not look at this as a hard date for accepting or rejecting cases. Instead reference the criteria indicated below.

Question #3:
Who manufacturers Heparin and what did the FDA recall?

Baxter International, Inc. is the manufacturer of Heparin that comes in vials and as "HEPLOCK" Heparin flush products, all of which were recalled. These products were thought to have become contaminated in China during the manufacturing process. The FDA has also recalled Heparin that comes in prefilled syringes made by AM2PAT, Inc. that were distributed under three product labels: Sierra Prefilled, AM2PAT and B. Braun. These prefilled syringes were thought to have become contaminated at a manufacturing facility in North Carolina.

Question #4:
What kinds of problems will people have if exposed to the contaminated Heparin?

People may experience allergic reactions and suffer from a wide variety of symptoms as follows (listed in order of most severe to least severe):

• Organ Failure
• Heart Problems
• Shock
• Decreased blood pressure
• Chest pain
• Abdominal Pain
• Fainting
• Nausea or vomiting
• Low energy
• Skin redness
• Increased sweating
• Increased heart rate
• Throat swelling
• Headache
• Shortness of breath

Question#5 :
What is our criteria for accepting cases?

The criteria is as follows:

1. The person must have taken Heparin or an unknown drug. (We understand people may not recall the drug name.)
2. The drug must have been taken during surgery, dialysis or while bedridden.
3. The person must have taken the drug at some point from January 2007 until the present.
4. The person must have experienced problems AFTER having taken the drug such as those listed in #4 above.

More information on Heparin recall:

Baxter's Multipledose Vial Heparin Linked to Severe Allergic Reactions

FDA.gov – Feb 11, 2008

Baxter to Proceed with Recall of Remaining Heparin Sodium Vial Products

FDA.gov Feb 28, 2008

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