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Public Health Advisory - FDA Investigates Bad Blood Thinner

Posted by Jane Akre
Tuesday, February 12, 2008 10:55 AM EST
Category: Major Medical, Protecting Your Family
Tags: Heparin, FDA and Prescription Drugs, Defective Drugs, Wrongful Death

The FDA has issued a public health advisory over heparin which is causing allergic reactions since the first of the year. Production has stopped

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Heparin has been in the news lately as the anti-coagulant given in the IV solution to the hospitalized newborn twins of Dennis Quaid in a quantity so great they started to bleed out from the overdose.

Dennis and Kimberly Quaid sued drug maker Baxter Healthcare for making vials in the smaller dose and larger dose with virtually the same blue labels.

Now there is more bad news for the drug maker.  Following reports of serious allergic reactions and possibly four deaths - Baxter Healthcare has temporarily stopped making the multiple-dose vials of heparin sodium.

Problems have been noted primarily in kidney dialysis and heart surgery patients. Four have died, though the connection to heparin has not been firmly established.

Since the end of 2007, the Food and Drug Administration (FDA) has received about 350 reports of problems associated with injectable heparin compared to fewer than 100 reports in all of 2007.

Patients report difficulty breathing, nausea or vomiting. And even with as few as several 1,000 units per milliliter of heparin, some have experienced excessive sweating with a sharp drop in blood pressure.

As these adverse reports began coming in, Baxter began recalling the affected lots January 17th. But the company has stopped production as other lots of Baxter’s multi-dose seem to also be affected.

Since heparin is considered a “medical necessity” that has been in production since the 1930s, the FDA and CDC are quickly trying to determine the cause the adverse events, taking samples of the products and inspecting facilities and the manufacturing process. 

More than one million of the multi-dose vials of heparin are sold each month with Baxter making 35 million vials or half of the U.S. hospital supply. 

The IV medication helps millions of patients avoid potentially life-threatening blood clots. The anti-coagulant (blood thinner) is used in operating rooms, dialysis centers and in emergency rooms. 

While the FDA is working to investigate, doctors are urged to use the lowest dose possible on patients and to monitor them closely. Others are switching to the nearest competitor from manufacturer, Schaumburg, Illinois based APP, formerly known as Abraxis Bioscience Inc. 

Derived from pig intestines, the drug generates $30 million in sales for Baxter annually.

Recalled lots include:

NDC NUMBERS 0641-2440-45, 0641-2440-41, 0641-2450-45 and 0641-2450-41; LOTS: 107054, 117085, 047056, 097081, 107024, 107064, 107066, 107074, 107111

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