FDA

House Energy and Commerce Committee ranking Republican Rep. Joe L. Barton of Texas asked for clarification from the Food and Drug Administration (FDA) this week concerning deaths related to the blood thinner heparin. His letter called into question the adequacy of the agency's review of the deaths. He highlighted previous correspondence from the FDA he received in October that tied two cases of heparin-related deaths to drugs produced by American Pharmaceutical Partners (APP). The APP heparin was not tested for contaminants, according to a FDA letter. FDA spokeswoman Karen Riley gave no substantive response but said "the agency looks forward to clarifying the issue with Barton."

How can the United States Supreme Court or President Bush seriously think that it is a good idea to preempt private law suits against pharmaceutical companies based upon FDA approval. Surely this approach to rights reserved to states and individuals can't be removed in such a cavalier fashion.
 

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Heparin contamination

The FDA announced that onersulfated chondroitin sulfate has been found as a contaminant in Heparin, a bloodthinning drug distributed by Baxter Internation Inc. This contaminant  does not occur naturally. The question is how the Heparin became contaminated.

Hundreds have been injured, including 19 deaths.  Adverse reactions include: refractory hypotension leading to organ damage, organ failure, shock, and death. Baxter began recalling  Heparin in January .

Heparin is used before certain  surgeries, including coronary artery bypass graft surgery, and in kidney patients before they undergo dialysis. Heparin is often initiated using a high bolus dose given directly into the bloodstream.  This administration is the most risky for adverse effects.

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Heparin

China has once again flooded the US market with contaminated products. It has a history of sending over lead painted toys and other dangerous goods and the US has a history of doing a poor job of inspecting or regulating Chinese imports.

The latest imported health danger is Heparin, a blood thinner, made from the mucous membranes of the intestines of slaughtered pigs. This is often produced in China by unregulated family workshops. The contaminant, identified as oversulfated chondroitin sulfate, a cheaper substance, slipped through the usual testing and was recognized only after more sophisticated tests were used.

Congress has belated taken action to pass legislation requiring far more aggressive inspections of Chinese products. This is poor comfort for the over 80 patients known to have had severe reactions known to be related to the contaminant.

Consumers of this product have a valid cause of action despite the continual attempts to block the right to trial by jury by the conservative interest groups which have controlled appellant courts and legislative bodies too long.
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Heparin

Baxter Issues Urgent Nationwide Voluntary Recall and lists the following adverse reactions:

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, feeling your heart beat strong or fast, 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 and difficulty opening the mouth.

What has been hidden in the announcement is that the consequences to the reaction this blood thinning product can be serious and life threatening.

The FDA has little budget to check out the drugs it approves and must rely upon the representations given by the very company that is under intense pressure to aquire a quick release of the product. Unfortunately, some states including Texas proclude litigation concerning products with FDA approval. This is an intense legal fight by the attorneys representing victims of dangerous pharmacuticals.

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