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Heparin

Patients who need treatments and surgeries for several reasons require injections of substances that prevent coagulation and clotting of certain areas, and many different products have been formulated to help prevent this natural process so that these patients can receive the full benefit of these treatments. Recent years have seen the introduction of several innovative products designed to do just that, but recent news has also shown that there is a risk involved that may be quite unreasonable.

Anticoagulant Products in Question:

Specifically, there are two products that have come under intense scrutiny in recent times, and they are:

  1. Heparin and Normal Saline pre-filled flushes. These products are generally known by two brand names, Sierra Pre-Filled Inc and B. Braun.
  2. Baxter Heparin Multiple-dose injections

Each of these products has been recalled, and any products that are pulled from shelves are only done so when the dangers faced by those using them are extreme and immediate.

There are also two large corporations involved with this issue, and they are AM2 PAT, Inc., which distributes the pre-filled flushes and the Baxter Corporation, which provides the multiple-dose injections.

The FDA Recall of Heparin:

As is almost always the case with recalls, there are immediate health and side effect concerns associated with these products. In regards to the pre-filled flushes, which are offered in 3ml and 5ml sizes for Heparin and 3ml, 5ml, and 10ml sizes for Normal Saline and one lot of Heparin IV flush syringes (1003-02, Lot 070926H), it’s been alleged that these lots/products are contaminated with Serratia marcescens which has resulted in serious bacterial infections.

2008 Chinese Heparin contamination

In March 2008, major recalls of heparin were announced by the FDA due to contamination of the raw heparin stock imported from China. According to the FDA, the contaminated heparin killed 81 people in the United States. The contaminant was identified as an "over-sulphated" derivative of chondroitin sulfate, a popular shellfish-derived supplement often used for arthritis.

The Baxter recall was initiated because the multiple-dose injections allegedly lead to non-specific but serious and almost immediate side effects, including abdominal pain, diarrhea, dizziness, drug ineffectiveness, dyspepsia, erythema, flushing, headache, hyperhidrosis and many others according to the FDA.

 

Heparin Overdose News:

Actor Dennis Quaid's twelve-day-old twins mistakenly were given an adult dosage of Heparin , which is 1,000 times the recommended dosage for infants, in November 2007The overdose allegedly arose because the labeling and design of the adult and infant versions of the product were easily confused. The Quaid family subsequently sued the manufacturer, Baxter Healthcare Corp., for over $50,000.

 

If you have had these products used during treatment and have suffered as a result, contact an attorney as soon as possible to schedule an initial consultation.

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