Dangerous Products ALERT

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DANGEROUS PRODUCTS ALERT

HOMECHOICE "In-Home" DIALYSIS MACHINES

On March 3, 2010, Baxter International Inc. announced a recall of its in-home dialysis device that has been linked to serious injury reports and at least one death in the last two years.   The Food and Drug Administration has classified the action as a Class I recall, the agency's most serious, for Baxter's HomeChoice and HomeChoice PRO peritoneal dialysis cyclers, because the device is causing an "'overfill' of fluid in the patient's stomach."   A Class I recall classification applies to problems that can cause “serious adverse health consequences or death.”   Meanwhile, Baxter said it is "still investigating the source of the problems and is working on changes to labeling and software to prevent patient errors."

If you or someone you know has been injured by Baxter’s in-home dialysis machines, contact the MARCARIAN LAW FIRM for a no-cost evaluation of your condition.

HEPARIN

If you or a loved one has recently received heparin, an injectable blood thinning medication, and is exhibiting problems ranging from dizziness and fainting to racing heart beat, you may contact our office for a free consultation.

In January 2008, Baxter Healthcare Corp., a Deerfield, Ill.-based company voluntarily recalled nine lots of the vials after finding out dialysis patients had allergic reactions to the drug. Baxter recently announced it would stop manufacturing multiple-dose vials of its blood thinning medication and further indicated that the problems were not limited to the nine lots in the recall.

Kidney-failure patients receive heparin to prevent clotting of blood during the dialysis process. The drug is also used in certain types of heart surgery.

FDA said nearly all the reported problems have been in dialysis patients who received high doses of heparin over a short time. Agency scientists said doctors who continue to use the drug should use the lowest doses possible and administer it slowly.

Government inspectors are examining Baxter's manufacturing sites to locate the source of the problems, FDA said. Baxter has agreed to cooperate with the investigation. According to a Baxter spokeswoman, Erin Gardiner, Baxter’s testing found “trace differences” in some lots of the blood thinner heparin, including quantities in which the active ingredient came from a supplier’s plant in China. FDA officials considered a recall, but said they decided not to because it would create a dangerous shortage of the drug. Baxter accounts for about half the U.S. supply for the blood-thinning medicine. Instead, the FDA warned doctors to use it with "caution when medically necessary."