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FDA Gives Warnings and Instructions for Heparin Sodium Injection (Baxter)

As another Baby dies from a link to Heparin the folowing was issued from the FDA recently

Heparin sodium is an anticoagulant (blood thinner) that is commonly administered intravenously.  It is used in patients undergoing kidney dialysis, certain types of cardiac surgery, and treatment or prevention of other serious medical conditions, including deep venous thrombosis (DVT) and pulmonary emboli.  In many settings heparin treatment is initiated using high doses (5000-50,000 units) given directly into the blood stream (intravenously) as a bolus (over a short period of time, usually a few minutes). Serious adverse events have recently been reported in patients who received these higher bolus doses.  The serious adverse events include allergic or hypersensitivity-type reactions, with symptoms of oral swelling, nausea, vomiting, sweating, shortness of breath, and cases of severe hypotension requiring treatment.  Most events developed within minutes of heparin initiation although the possibility for a delayed response has not been excluded..  The reports have largely involved use of multiple-dose vials.  However there have been several cases in which product from multiple, single-dose vials have been combined to administer a bolus dose. 

FDA is providing the following recommendations to physicians, dialysis center staff, and other health care providers when using heparin sodium for injection.

• When bolus use is required, try to use a heparin product from another manufacturer or an alternate anticoagulant
• When Baxter product is the only heparin product available and use of heparin is considered to be medically necessary:
  • Administer infusions without using a bolus dose whenever possible
  • Use the lowest dose necessary at the slowest infusion rate acceptable to obtain the desired effect 
  • Closely monitor the patient for adverse events, particularly hypotension and signs and symptoms of hypersensitivity, and ensure that resuscitation equipment is available.
  • Consider the potential risks and benefits in individual patients of pretreatment with corticosteroids or antihistamines before the heparin is administered.  At this time FDA does not have data to determine if such pretreatment is effective.

Heparin sodium is a pork-derived product that has been marketed in the United States for nearly 70 years.  It is estimated that over 1 million multiple-dose vials of heparin are sold per month in the U.S., about half of which are manufactured and distributed by Baxter Since late December 2007 Baxter and FDA have received nearly 350 reports of adverse reactions, and about 40% of the cases are estimated as serious, based upon preliminary and ongoing review.  The number of reports seen in the past two months is a marked increase from the number of reports associated with heparin use normally received in a similar time period. 

The majority of reported events occurred at hemodialysis centers.  In early January, 2008, clusters of these allergic adverse event reports came to the attention of the CDC and to Baxter.   Available data at that time suggested a link of these cases to product from specific heparin manufacturing lots.  This resulted in Baxter recalling 9 product lots on January 17, 2008.   FDA initiated inspections of Baxter’s U.S. manufacturing plant and processes the same day.

Since the January product recall, new reports indicate that adverse events are not limited to only the recalled heparin lots.  Baxter and FDA have learned of cases occurring in hospitals where heparin was used during cardiac surgery and in patients undergoing photopheresis.  Like the events associated with dialysis, most have resolved with medical management.  Four patients have died since these adverse events were noted; the relationship between the deaths and the heparin use is not certain.   

The underlying cause for the abrupt increase in the number of adverse events reported for Baxter’s heparin sodium is under investigation.   FDA inspectors and scientists are working independently and in collaboration with the Centers for Disease Control and Baxter to discover the underlying cause of the adverse events.  FDA personnel and laboratories are conducting intensive inspection and testing related to Baxter’s heparin sodium.  FDA is also seeking advice from outside experts in the manufacture and clinical use of heparin in order to help guide our investigation.  

These are serious consequences to suffer due to the negligence of medical professionals. Contact us if you or anyone you know have experienced any kind of medical negligence.

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