Heparin Deaths

October 14, 2008

In February, Baxter International Inc. announced that they were proceeding with the voluntary recall of remaining lots and doses of its heparin sodium injection multi-dose, single-dose vials and HEP-LOCK heparin flush products. This followed an initial recall In January. Contaminated heparin has also been found in association with some medical devices, such as certain catheters. Some of these medical devices have been recalled.

Heparin is one of the oldest drugs, having been developed in 1916. It is widely used as an injectible anti-coagulant. It can also be used to form an anti-coagulant surface on various medical devices such as test tubes and dialysis machines.

A serious side-effect of heparin is heparin-induced thrombocytopenia (HIT syndrome). HITS is caused by an immunological reaction that makes platelets a target of immunological response, resulting in the degradation of platelets. This is what causes thrombocytopenia. This condition is usually reversed on discontinuation, and can generally be avoided with the use of synthetic heparins. There is also a benign form of thrombocytopenia associated with early heparin use, which resolves without stopping heparin.

Rarer side-effects include alopecia and osteoporosis with chronic use.

As with many drugs, overdoses of heparin can be fatal. In September 2006, heparin received worldwide publicity when 3 prematurely-born infants died after they were mistakenly given overdoses of heparin at an Indianapolis hospital.

Serious injuries and deaths have been associated with the use of heparin, a blood-thinning drug that contained active pharmaceutical ingredient (API) from China.

Nearly all reported adverse reactions have occurred in three specific areas of product use – renal dialysis, invasive cardiovascular procedures and apheresis procedures. Reported adverse patient reactions have included:

-stomach pain or discomfort,
-nausea,
-vomiting,
-diarrhea,
-decreased or low blood pressure,
-chest pain,
-fast heart rate,
-dizziness,
-fainting,
-unresponsiveness,
-shortness of breath,
-the feeling of a strong or rapid heartbeat,
-drug ineffectiveness,
-burning sensation,
-redness or paleness of skin,
-abnormal sensation of the skin, mouth or lips,
-flushing,
-increased sweating,
-decreased skin sensitivity,
-headache,
-feeling unwell,
-restlessness,
-watery eyes,
-throat swelling,
-thirst,
-bleeding tendencies,
-difficulty opening the mouth,
-those that may resemble the symptoms of Heparin-Induced Thrombocytopenia (HIT), such as a low platelet count, bruising, loss of circulation to the hands and feet, gangrene, bleeding, and blod clots,
-and additional symptoms, including potential long-term effects that have not been identified.


Some of these reactions, particularly profound and refractory hypotension, may be severe or life-threatening.

On the web:

http://en.wikipedia.org/wiki/Heparin

http://www.fda.gov/cder/drug/infopage/heparin/

This information about the heparin catastrophe is provided by Attorney Gordon Johnson, in conjunction with the Nolan Law Group of Chicago, IL. The Johnson Law Office is affiliated with The Nolan Law Group on Heparin litigation.  The Nolan Law Group is presently involved in the litigation on behalf of those affected by the distribution of contaminated heparin.

www.heparin-law.com

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Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.

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