The contaminant which caused the numerous cases of allergic reactions to the blood thinner has been found.
In April, 2008, the FDA announced it had identified the contaminant in Baxter Heparin blood thinner product which was undetected in testing prior to release of the anti coagulant.
As of April, 62 deaths have been allegedly linked to Heparin and more than 350 allergic reactions have also been reported. Heparin is manufactured overseas from pig intestines. It is believed that the contaminant was introduced at the overseas plant.
Heparin has been in use since the 1930's and millions of doses have been administered, generally to stop potentially fatal blood clots.
Baxter can be found on the web at www.baxter.com.
Tuesday
Heparin Recall Linked To Deaths
Heparin, a blood thinner manufactured by Baxter, has apparently been linked to up to 62 deaths as of April of 2008.
In January of 2008, Baxter announced a voluntary recall of all multi dose vials of Heparin from a certain nine lots.
In February, Baxter announced a recall of all Heparin in hospitals and surgery centers nationwide.
As of April, 2008, more than 62 deaths were allegedly linked to Heparin as we as 350 allergic reactions to the blood thinner. Allergic reactions appear linked to the amount of dosage with higher amounts resulting in more serious side effects.
Adverse side effects include: stomach pain; shortness of breath; nausea; throat swelling; low blood pressure; chest pain; accelerated heart rate; dizziness; headaches; restlessness; dizziness; vomiting; diarrhea; fainting; unresponsiveness; tachycardia; drug ineffectiveness; burning sensations; redness or paleness of skin; abnormal sensation of the skin, mouth, or lips; flushing; thirst and difficulty opening the mouth, increased sweating; decreased skin sensitivity; watery eyes; and low blood pressure.
The apparent cause of the Heparin reaction is linked to the manufacture of the blood thinner overseas.
Heparin has been in use in the United States for over 70 years and before the recall, more than 100,000 doses were delivered daily.
Baxter can be found on the web at www.baxter.com.
Baxter Heparin Recall - All lots recalled
Baxter has recalled all lots of blood thinner Heparin after recalling only nine lots in January of 2008.
The announcement, which came in February of this year, voluntarily recalls all remaining lots of the anti coagulant.
According to a Baxter's website, "the FDA and Baxter concluded that removing additional lots and doses of Baxter's heparin from the market earlier would have created more risk to patients requiring heparin therapy than the increased potential for experiencing an adverse reaction"
With the recall, there is an expected shortage of blood thinner products for hospitals, operating rooms and dialysis centers. However, Baxter and FDA believe there is sufficient supplies from other vendors to cover current needs.
Adverse reactions to Heparin 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 and difficulty opening the mouth. Some of these reactions, particularly profound and refractory hypotension, may be severe or life-threatening.
Customers of Heparin, which is a presription only product, have been requested to cease using the product and return to Baxter.
Baxter can be found on the web at www.baxter.com
Baxter Heparin Recall
Baxter Heparin, a blood thinner, is under a nationwide voluntary recall as a precautionary measure after several allergic type reactions were reported.
Baxter reports on their website, symptoms which may result from the use of Heparin include.. "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. Some of these reactions may be or life threatening."
Heparin is a prescription only blood thinner (anti coagulant) primarily used for hemodialysis and cardiac invasive procedures.
The recall issued in January is not for the entire production line of Heparin, but for nine lots produced during a certain time frame. Users are instructed to cease using Heparin for treatment and return the product to Baxter.
Baxter is available on the web at www.baxter.com
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