Friday, May 23, 2008

Heparin Alert From The FDA!

There are many people all over the world who need medical care in the
form of dialysis for kidneys, IV fluids for many reasons and other
types of procedures designed to help them cope with existing problems
or even to get past them.

Medical professionals are concerned when administering this care they
need to prevent the body's natural reaction to any sort of open wound,
which is to immediately manufacture substances that lead to clotting.

There are several products on the market that helps slow or prevent
this clotting. According to news published on the FDA's Web site, a few
of these anti-coagulant products and the syringes in which they're
packaged have been recalled due to their link to the development of
serious side effects.

Pre-Filled Flushes Recalled

AM2 PAT, Inc. is the manufacturer of both Heparin and Normal Saline
pre-filled flushes, and these products are known by the brand names of
Sierra Pre-Filled Inc and B. Braun. The products are sold in 3ml and
5ml sizes for Heparin and 3ml, 5ml, and 10ml sizes for Normal Saline.
One lot of Heparin IV flush syringes (1003-02, Lot 070926H) was
contaminated with Serratia marcescens which has resulted in patient
infections. Serratia marcescens is a bacterium that can cause urinary
tract infections and even carries a significant mortality rate if it
goes undetected.

Baxter Healthcare Corporation

Baxter manufactures and distributes the products generally known as
multi-dose and single-use vials of heparin sodium for injection and
heparin lock flush solutions.
These products have been voluntarily recalled because of the tendency
in patients to show several troubling side effects:

Oral swelling
Organ failure
Shortness of breath
Severe hypertension

Most reported cases have involved an almost immediate development of
those side effects.

The FDA announced the possibility that these potentially severe side
effects could develop at a later time.

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