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NATIONWIDE RECALL OF HEPARIN PRODUCTS:
Following reports of serious adverse reactions and deaths, several manufacturers of products containing Heparin Sodium USP have issued natiowide recalls. Serious adverse events reported include allergic or hypersensitivity-type reactions, with symptoms of oral swelling, nausea, vomiting, sweating, shortness of breath, and cases of severe hypotension (low blood pressure) requiring treatment. The FDA has reported that some of the adverse reactions and deaths may be the result of a Heparin-like contaminate found in some of the recalled lots.

Users of any recalled Heparin products are warned to discontinue their use immediately. Patients who may be suffering any side effects or problems related to their use of heparin products should contact their physicians.

If you or a loved one suffered a serious side effect following the use of a product containing heparin, please contact us for a free and confidential case review.


FDA PUBLISHED RECALL NOTICES
Covidien Initiates Voluntary Recall of Pre-Filled Syringes Containing Heparin

FOR IMMEDIATE RELEASE -- MANSFIELD, Massachusetts – March 28, 2008 - Covidien, formerly Tyco Healthcare, was recently notified by its supplier, Scientific Protein Laboratories LLC (SPL), of a nation-wide recall of Heparin Sodium USP active pharmaceutical ingredient. The voluntary recall affects the following 32 lots manufactured and distributed by Covidien in the United States.

Product

Lot Numbers

REF # 8881580121
Monoject PreFillTM 10U/mL Heparin
Lock Flush Syringe, 10mL
7082274
7113214
REF # 8881580123
Monoject PreFillTM 10U/mL Heparin
Lock Flush Syringe, 3mL
7051524
7113214
REF # 8881580125
Monoject PreFillTM 10U/mL Heparin
Lock Flush Syringe 5mL
7051524
7082274
7113164
7113174
REF # 8881580300
Monoject PreFillTM 10U/mL Heparin
Lock Flush Syringe
2.5mL in 3mL syringe
7051444
REF # 8881581125
Monoject PreFillTM 10U/mL Heparin
Lock Flush Syringe 5mL, with BLUNTIP plastic cannula
7082274
REF # 8881590121
Monoject PreFillTM 100U/mL Heparin
Lock Flush Syringe 10mL
7113064
REF # 8881590123
Monoject PreFillTM 100U/mL Heparin
Lock Flush Syringe 3mL
7041194
7072154
7113034
8010194
REF # 8881590125
Monoject PreFillTM 100U/mL Heparin
Lock Flush Syringe 5mL
7041194
7102804
7041204
7113034
7051534
7113044
7051544
7113054
7051554
7113104
7071924
7113114
7072034
7113154
7072044
8010064
7072054
8010114
7072064
8010134
7072154
8010174
7082284
REF # 8881591125
Monoject PreFillTM 100U/mL Heparin
Lock Flush Syringe 5mL, with BLUNTIP plastic cannula
7082284

Covidien began recalling the lots today as a precautionary measure. This product recall was initiated due to a notification received from the supplier, SPL, disclosing that two lots of Heparin Sodium USP Active Pharmaceutical Ingredient acquired by Covidien had a heparin-like contaminant. To date, Covidien has not received any adverse event reports related to this issue. Although a very small product line for Covidien, the Company is committed to following the direction of the Food and Drug Administration (FDA) regarding this matter.

The FDA has received reports of serious injuries and/or deaths in patients who have been administered Heparin injectable products of other companies containing this contaminant. As indicated in the notification issued by the supplier SPL, typical symptoms include anaphylactic-like reactions such as low blood pressure, shortness of breath, nausea, vomiting, diarrhea and abdominal pain.


B. Braun's Supplier Recall of Heparin API Prompts Voluntary Recall of Heparin Solutions
Scientific Protein Laboratories LLC (SPL) manufactures Heparin Sodium USP active pharmaceutical ingredient that is used by B. Braun Medical Inc. to produce Heparin Sodium in 5% Dextrose and 0.9% Sodium Chloride injection solution

 FOR IMMEDIATE RELEASE --Irvine, CA -- March 21, 2008 --- B. Braun Medical Inc. was recently notified by its supplier, Scientific Protein Laboratories LLC (SPL) of a nationwide recall of Heparin Sodium USP active pharmaceutical ingredient (API). The voluntary recall affects the following 23 Finished Product (FP) lots manufactured and distributed by B. Braun Medical Inc. nationwide and to Canada.

B. Braun FP Lot #

B. Braun FP Material

Description

NDC Numbers

CAN DIN

J7C684

P5771

Heparin Sodium 25,000 Units in 5% Dextrose Injection (500mL)

0264-9577-10

N/A

J7D496

P5771

Heparin Sodium 25,000 Units in 5% Dextrose Injection (500mL)

0264-9577-10

N/A

J7C470

P5872

Heparin Sodium 25,000 Units in 5% Dextrose Injection (250mL)

0264-9587-20

N/A

J7D580

P5671-00

Heparin Sodium 20,000 Units in 5% Dextrose Injection (500mL)

N/A

02209713

J7E420

P5872-00

Heparin Sodium 25,000 Units in 5% Dextrose Injection (250mL)

N/A

02209721

J7C611

P8721

Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL)

0264-9872-10

01935933

J7C557

P8721

Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL)

0264-9872-10

01935933

J7C477

P8721

Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL)

0264-9872-10

01935933

J7C705

P8721

Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL)

0264-9872-10

01935933

J7D485

P8721

Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL)

0264-9872-10

01935933

J7E415

P8721

Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL)

0264-9872-10

01935933

J7E416

P8721

Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL)

0264-9872-10

01935933

J7E494

P5872

Heparin Sodium 25,000 Units in 5% Dextrose Injection (250mL)

0264-9587-20

N/A

J7E500

P5771

Heparin Sodium 25,000 Units in 5% Dextrose Injection (500mL)

0264-9577-10

N/A

J7E577

P5771-00

Heparin Sodium 25,000 Units in 5% Dextrose Injection (500mL)

N/A

01935941

J7E489

P8721

Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL)

0264-9872-10

01935933

J7N556

P5872

Heparin Sodium 25,000 Units in 5% Dextrose Injection (250mL)

0264-9587-20

N/A

J7P404

P5771

Heparin Sodium 25,000 Units in 5% Dextrose Injection (500mL)

0264-9577-10

N/A

J7N604

P5771

Heparin Sodium 25,000 Units in 5% Dextrose Injection (500mL)

0264-9577-10

N/A

J7P476

P5872

Heparin Sodium 25,000 Units in 5% Dextrose Injection (250mL)

0264-9587-20

N/A

J7N519

P8721

Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL)

0264-9872-10

01935933

J7N676

P8721

Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL)

0264-9872-10

01935933

 

B. Braun Medical Inc. began recalling the lots on March 21, 2008 as a precautionary measure. This product recall was initiated due to a notification received from the supplier, Scientific Protein Laboratories (SPL), disclosing that one lot of Heparin Sodium, USP Active Pharmaceutical Ingredient acquired by B. Braun Medical Inc. has a heparin-like contaminant. To date, B. Braun Medical Inc. has not received any adverse event reports related to this issue.

The Food and Drug Administration has received reports of serious injuries and/or deaths in patients who have been administered Heparin injectable products of other companies containing this contaminant. As indicated in the notification issued by the supplier SPL, typical symptoms include anaphylactic-like reactions such as low blood pressure, shortness of breath, nausea, vomiting, diarrhea and abdominal pain.


American Health Packaging Announces a Recall of Approximately 1,400 Units of Heparin Sodium Vial Products as Part of Broader Baxter Recall
Units for Pharmacy Automated Equipment Part of Broader Recall

FOR IMMEDIATE RELEASE -- Valley Forge, PA -- March 20, 2008 --- American Health Packaging (AHP), a subsidiary of AmerisourceBergen Corporation (NYSE:ABC), today announced a voluntary recall of 1,421 units (25 vials per unit) of 10000 USP units/ml heparin sodium injection 1ml vials as part of the broader February 29, 2008 recall of Heparin products made by Baxter Healthcare Corporation. The vials were manufactured by Baxter and then placed by AHP into individually labeled bags for use in pharmacy automation equipment. The AHP packages where sold to five hospitals in Georgia and California, all of whom were notified of the recall earlier this month. Baxter Healthcare will reimburse AHP for the recalled product.

The recalled products are APS HEPARIN 10MU/ML (10000 USP units/ml) 1ml SDV 25UD (bag) NDC # 00641-0410-25, lot numbers 074155, 073089, 073391, 073613, 070095A, 073712, 072907, 073454, 070095D and APS HEPARIN SDV 10MU (10000 USP units/ml) 1ml 25UD (box and rod) NDC # 00641-0410-25, lot numbers 070095B, 070095C, 068286, 067755. AHP instructed customers to return any and all of these product lots remaining in inventory.

This recall was initiated due to the Baxter Healthcare's recall which stated, ".voluntary recall of Heparin Sodium Injection to include all lots of single and multi-dose vial products, due to an increase in reports of adverse patient reactions including abdominal pain, burning sensation, chest pain, diarrhea, dizziness, drug ineffectiveness, dyspepsia, dyspnia, erythema, flushing, headache, hyperhidrosis, hypoesthesia, hypotension, including profound and refractory hypotension, increased lacrimation, loss of consciousness, malaise, nausea, pallor, palpitations, paresthesia, paresthesia (oral), pharyngeal adema, restlessness, vomiting/retching, stomach discomfort, tachycardia, thirst, trismus, and unresponsiveness to stimuli. The reports of profound and refractory hypotension usually occur with the first few minutes of bolus administration."


Baxter to Proceed with Recall of Remaining Heparin Sodium Vial Products

FOR IMMEDIATE RELEASE -- DEERFIELD, Ill., February 28, 2008 – Baxter International Inc. announced today that the company is proceeding with the voluntary recall of all remaining lots and doses of its heparin sodium injection multi-dose, single-dose vials and HEP-LOCK heparin flush products.

The company initially recalled nine lots of heparin sodium injection multi-dose vials on January 17, 2008 as a precautionary measure due to a higher than usual number of reports of adverse patient reactions involving the product and suspended production earlier this month.

Given the widespread use of this blood thinner and the impact a product shortage would have on operating rooms, dialysis centers and other critical care areas, 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. Accordingly, the FDA and Baxter decided not to recall all Baxter heparin vial products at that time. The FDA has now concluded that there is sufficient capacity on the part of other suppliers that Baxter's recall will not jeopardize access to this drug, and has told Baxter that the company can now proceed with recalling its remaining heparin sodium injection and heparin flush products.

Although the vast majority of the reports of adverse reactions have been associated with the multi-dose products, Baxter is taking the precautionary step of recalling all remaining heparin sodium injection and heparin flush products that are currently on the market. In addition to the previously recalled lots of heparin sodium injection 1000 units/mL 10mL and 30mL multi-dose vials, Baxter's recall will now include the remaining lots of those products and heparin sodium injection 5000 units/mL 10mL multi-dose vials, heparin sodium injection 10,000 units/mL 4mL multi-dose vials, heparin sodium injection 1000 USP units/mL, 5000 USP units/mL, and 10,000 USP units/mL single-dose vials, and all HEP-LOCK and HEP-LOCK U/P, 10 USP units/mL and 100 USP units/mL vials, both preserved and preservative-free.

This recall does not involve Baxter's heparin pre-mix IV solutions in bags: heparin sodium in 5% dextrose injection and heparin sodium in 0.9% sodium chloride injection.

"We have assurance from the U.S. Food and Drug Administration that there is an adequate supply in the market to meet the demand for these critical and lifesaving drugs," said Peter J. Arduini, president of Baxter's Medication Delivery business. "The safety and quality of our products is always our highest priority, and we will continue to collaborate with the FDA as we work to determine the cause of the increased rate of adverse reactions and resolve this issue."

Nearly all reported adverse reactions have occurred in three specific areas of product use – renal dialysis, invasive cardiovascular procedures and apheresis procedures. Reported 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, 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.


Baxter Issues Urgent Nationwide Voluntary Recall of Heparin 1,000 Units/ml 10 and 30ml Multi-Dose Vials

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

FOR IMMEDIATE RELEASE -- DEERFIELD, Ill., January 25, 2008 – Baxter Healthcare Corporation has announced the voluntary recall of nine lots of heparin sodium injection 1000 units/mL 10mL and 30mL multi-dose vials. The company began recalling the lots on January 17, 2008 as a precautionary measure due to an increase in the number of reports of adverse patient reactions that may be associated with the product. Baxter is conducting a thorough investigation of these reports to identify the cause of the increase in allergic-type 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. Some of these reactions may be severe or life threatening.

Heparin is a prescription, injectable blood anticoagulant (also called a blood thinner). The 1,000 units/mL multi-dose vials are primarily used for hemodialysis and cardiac invasive procedures. To date, the company has not observed a significant increase in adverse event reports occurring with any other of its heparin presentations.

Customers have been instructed to discontinue use and segregate the recalled product from the rest of their inventory.


 

INFORMATION, ADVISORIES & ALERTS FROM THE FDA

6/18/2008: Updated Questions and Answers on Heparin Sodium Injection (Baxter)
1.  What is heparin? (new question added 6/18/2008)

Heparin is one of a class of medications called anticoagulants that are commonly referred to as blood thinners.  Heparin makes an anti-clotting protein in your body work better, thus decreasing the clotting ability of the blood.

Heparin is made from pig intestines and has been marketed in the United States since the 1930s.

Heparin is available as a solution (liquid) to be injected intravenously (into a vein) or deeply under the skin and as a dilute (less concentrated) solution to be injected into intravenous catheters.  It may be given to you by a nurse or other health care provider, or you may be told to inject the medication by yourself at home.

2.  What is heparin used for? (new question added 6/18/2008)

The medication is used to prevent and treat blood clots in the veins, arteries and lungs. Heparin is commonly used before certain types of surgery, including coronary artery bypass graft surgery, and in kidney patients before they undergo dialysis.

Some medical devices contain or are coated with heparin, and some diagnostic testing products are manufactured using heparin.  FDA is aware that some of these products have been affected by the recent contamination.

3. What did FDA announce? (answer revised 6/18/2008)

In January, FDA announced it had learned about an increase in the number of serious allergic-type hypersensitivity reactions and cases of severe hypotension in association with the use of intravenous bolus doses of heparin sodium for injection manufactured by Baxter.  In order to minimize the risks associated with use of this product, FDA provided recommendations to physicians and healthcare providers to avoid bolus dosing with Baxter heparin whenever possible and recommendations for strategies that may limit the occurrence or severity of adverse reactions if the use of heparin is medically necessary and Baxter heparin is the only heparin product available.  On February 28, 2008, Baxter Healthcare Corporation recalled all multi-dose and single-dose vials of heparin sodium for injection as well as HEP-LOCK heparin flush products.

4.  What products and what patients were affected by this? (answer revised 6/18/2008)

Products known to be affected are:  Baxter’s Heparin Sodium Injection multiple-dose vials (1000 units/mL concentration, 10 mL and 30 mL vials; 5000 units/mL concentration, 10 mL vials; and 10,000 units/mL, 4 mL vials).  The multiple-dose vials typically are used in patients who need large intravenous doses given quickly, sometimes called “bolus doses” in order to thin their blood over a very short period of time.  

Patients affected are:  patients with kidney failure on hemodialysis; patients undergoing certain types of cardiovascular surgery; patients undergoing other specialized treatments called photopheresis and plasmapheresis and some patients who have blood clots in arteries or veins, such as patients treated for blood clots in the lung (pulmonary embolism). Contaminated heparin may also be found in association with some medical devices, such as heparin lock flushes, oxygenators, and certain catheters.  Some of these devices have been recalled due to the contaminant.

5.  When did FDA learn about the adverse events? (answer revised 6/18/2008)

FDA learned of the occurrence of adverse events on January 9 from CDC investigators who were evaluating small clusters of these events in dialysis centers.  On January 16, 2008, FDA initiated an inspection of Baxter’s manufacturing plant in Cherry Hill, New Jersey.  At the time of the inspection, Baxter notified the Agency that nine lots of its heparin sodium were being recalled due to an increase in the rate of adverse events associated with these lots. The first limited recall was initiated on January 17, 2008.

6. What other companies make heparin for the US market?  Is FDA sure that these product(s) do not have the same risk? (question and answer revised 6/18/2008)

On February 28, 2008, Baxter recalled its heparin sodium injection single-dose vials, the remainder of its multiple-dose vials, and the heparin flush products from the market.   APP Pharmaceuticals, a heparin manufacturer and supplier of heparin sodium injection, shared the majority of the US market with Baxter.  When Baxter recalled on February 28th, APP Pharmaceuticals was able to increase its production capacity and take over as the major supplier of the US market.  Hospira and B. Braun also supply some heparin sodium for injection:  Hospira in single-use syringes, vials and bags and B. Braun in pre-mixed bags for infusion.  Baxter continues to produce large volume bags of heparin for injection; the heparin is obtained from a different source than the source used for the recalled products.

Prior to APP Pharmaceuticals becoming the major supplier of heparin sodium to the US market, its heparin active pharmaceutical ingredient (API) was screened to ensure that it did not contain the identified contaminant using the test methods posted on FDA’s website.  The major heparin suppliers to the US market have committed to test their heparin API prior to use and to only use non-contaminated API for products to the US market.

7. Is APP Pharmaceuticals able to provide enough heparin for injection to avoid a shortage? (revised answer 6/18/2008)

At this time, the supply of heparin sodium for injection appears sufficient to meet medical need within the US market.  FDA continues to work with manufacturers to monitor production and supplies.

8. What has FDA announced about heparin since Baxter’s recalls? (answer revised 7/3/2008)

After launching a disciplined, methodical examination, FDA scientists have identified a previously unknown contaminant in heparin active pharmaceutical ingredient (API) from China. The contaminant is oversulfated chondroitin sulfate. The contaminant activates enzymes that can generate inflammatory mediators (N Engl J Med 358;23 June 5, 2008 p2457). These mediators (chemicals that are released by immune cells) can lead to many of the observed symptoms such as low blood pressure, abdominal symptoms and shortness of breath. This provides additional support to the association of the adverse events with oversulfated chondroitin sulfate. The agency has made available information on two tests that FDA scientists have conducted to detect the contaminant in heparin and recommend their use to manufacturers and suppliers for screening the heparin API.

9.  What is an Active Pharmaceutical Ingredient or API? (new question and answer added 6/18/2008)

An API or active pharmaceutical ingredient is a substance or mixture of substances that, when delivered in a finished drug product, directly affects the structure or function of the body.

10. What steps has FDA taken? (answer revised 6/18/2008)

Along with overseeing the recall, FDA scientists have

  • Provided recommendations to health care professionals about strategies to limit the occurrence or severity of adverse reactions in cases where the use of heparin was medically necessary and Baxter heparin was the only heparin product available to the healthcare provider.
  • Launched a far-ranging investigation in the United States and abroad.
  • Inspected the domestic manufacturer (New Jersey facility) to assure there were no other contributing factors to the contamination (e.g., whether the heparin could have been contaminated by its packaging).
  • Traveled to China to conduct a thorough investigation at the plant that manufactured the heparin active pharmaceutical ingredient purchased by Baxter.
  • Notified FDA's key regulatory international partners.
  • Worked closely with the manufacturer and experts in academia and private laboratories to carry out a thorough chemical analysis of the suspect products and to identify the contaminant as oversulfated chondroitin sulfate. The agency made available information on two tests that FDA scientists have conducted to detect the heparin-like substance, and recommended their use to manufacturers and suppliers for screening the heparin active pharmaceutical ingredient (API).
  • Worked to ensure that a safe and adequate supply of heparin is available to the U.S. market.
  • Issued an Import Alert and Sample Assignment to ensure that all heparin products coming into the United States are tested for the contaminant.
  • Hosted a successful meeting of international regulators from eleven countries to discuss what to do about the heparin contamination.  Representatives of the U.S. and European Pharmacopoeias also attended.


11.   What kind of testing did FDA scientists conduct?

After conventional testing did not prove useful in detecting these contaminants, FDA experts developed new test methods for heparin API that use existing state-of-the-art technologies such as nuclear magnetic resonance, capillary electrophoresis, enzymatic kinetics, and bioassay.

12.  What products have been tested? What are the results? (question expanded and answer revised 6/18/2008)

FDA scientists tested samples of heparin crude materials, heparin active pharmaceutical ingredients (API), and finished heparin drug products. The sampled heparin API contained 5 percent to 20 percent of a contaminant that mimicked heparin activity so closely that it was not recognized by routine testing of these samples. Sampled heparin crude materials and finished heparin drug products contained amounts of contaminant in this range.

13.  What is the contaminant? (new question and answer added 6/18/2008)

Oversulfated chondroitin sulfate (OSCS), a substance that mimics the biological activity of heparin, was identified as the contaminant.

14.  Where is the contaminant found? (new question and answer added 6/18/2008)

The contaminant was found in samples of heparin crude materials, heparin active pharmaceutical ingredients (API), and finished heparin drug products.

15.  Is oversulfated chondroitin sulfate unsafe by itself or in combination with heparin? (new question and answer added 6/18/2008)

The adverse events were reported in patients who received heparin contaminated with oversulfated chondroitin sulfate.  The lab studies suggest that when oversulfated chondroitin sulfate is given alone or in combination to animals, similar adverse events occur (N Engl J Med 358;23 June 5, 2008 p2457) .

16.  Have all heparin products used in the U.S. been tested for the contaminant? (new question and answer added 6/18/2008)

The active pharmaceutical ingredient (API) used for products in the U.S. market has been tested for the contaminant.  FDA has been working with manufacturers to analyze the heparin API used to manufacture the existing finished products.  This testing will assure that no contaminated finished heparin products are available to the U.S. market.

17.  How did the contaminant get into the product?

At this point, FDA does not know how the contaminant got into the heparin active pharmaceutical ingredient (API). The agency is continuing to aggressively investigate the situation.

18. Why does the contaminant cause serious adverse events? (new question and answer added 6/18/2008)

The contaminant activates chemicals in the body called enzymes.  These enzymes cause the body to make inflammatory mediators (chemicals that are released by immune cells).  Inflammatory mediators can lead to some of the symptoms such as low blood pressure, abdominal symptoms and shortness of breath.  This mechanism can explain many of the serious adverse events that occurred immediately after patients were given the contaminated heparin.

19.  Has all contaminated heparin been removed from the U.S. market? (new question and answer added 6/18/2008)

Since March 10, FDA has been screening and reviewing all imported heparin products.  This gives FDA the opportunity to sample and test products that pose a significant risk to U.S. consumers.  FDA can ultimately refuse and request the destruction of products that appear to be contaminated based on the testing. In addition, FDA has been working with manufacturers to retrospectively analyze heparin sodium API. These measures have resulted in a number of recalls to remove contaminated heparin products from the U.S. market.

20. I received the Baxter product in the past.  Am I still at risk for a serious reaction? (revised answer 6/18/2008)

The serious reactions have generally occurred rapidly; usually within minutes of when heparin was given.  However, some patients undergoing cardiac procedures have developed very low blood pressures as late as an hour following the start of the heparin bolus. Other reports have noted adverse events of one kind or another that occurred even later than that.  In this case, it is more likely that the adverse events that occurred right away were related to the heparin. So it is unlikely that an adverse event of this type will happen a long time after the heparin was given.

21. Are there any long-term health effects from exposure to the contaminant? (new question and answer added 6/18/2008)

We do not know whether there could be long term health effects of the contaminant, since the contaminant was only recently discovered. The FDA is in the process of having this question investigated.

 


2/28/2008: Public Health Update: Recall of Heparin Sodium for Injection
The Food and Drug Administration is issuing this update to inform the public that

  •  Baxter Healthcare Corporation has extended its recall of multi-dose vials of heparin sodium for injection to also include single-dose vials of heparin sodium for injection.
  • As a precautionary measure Baxter is also recalling its heparin lock flush products. The heparin source manufacturer for lock flush solutions is the same as that for Baxter’s heparin sodium for injection.
  • Alternate heparin manufacturers are expected to be able to increase heparin production sufficiently to supply the US market.

Since FDA learned of the adverse events associated with the Baxter multi-dose heparin vials, the Drug Shortages Team at FDA has been working closely with APP, the other supplier in the US for heparin multi-dose and single-dose vials, to determine their manufacturing capacity. With the verification that APP can now adequately supply the US market Baxter is voluntarily recalling all of its multi-dose and single-dose vials. FDA has also confirmed that there are multiple U.S. suppliers of heparin lock flush products with substantial inventory, making a shortage of these products unlikely.

The recall notice issued by Baxter provides instructions to healthcare providers and institutions regarding the identification and disposition of their product they may have in their inventories. The only Baxter heparin-containing products that will remain on the market are large volume parenteral solutions containing 200 Units of heparin per 100 cc in 500 and 1000 cc total volume bags. No adverse events have been reported in relation to the large volume solution. The heparin source manufacturer for the large volume solution is different from that of the products being recalled.

On February 11, 2008, the FDA issued a public health advisory informing the public about reports of serious adverse events in patients who received bolus injections of heparin sodium primarily from multi-dose vials manufactured by Baxter Healthcare Corporation.

The underlying cause of adverse events reported for Baxter’s heparin sodium is still unknown and remains under investigation. FDA investigators and scientists are working independently and in collaboration with the Centers for Disease Control and Prevention, and Baxter to discover the underlying cause of the adverse events.

2/28/2008: Important Warnings and Instructions for Heparin Sodium Injection (Baxter)
The Food and Drug Administration is issuing this alert to:

  • inform the public about reports of serious adverse events in patients who received bolus injections of heparin sodium for injection primarily from multiple-dose vials manufactured by Baxter Healthcare Corporation, and to
  • recommend measures that may help to minimize these risks if this product must be used due to medical necessity.

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.

Heparin is also used in other clinical settings at lower doses or over longer periods of time; adverse events like those described above have not been seen with those uses. FDA is currently investigating whether similar adverse events have been reported for heparin products from other manufacturers.

Because of concern about the occurrence of these serious adverse events, Baxter has temporarily suspended manufacture of its multiple-dose vials of heparin sodium pending the completion of an extensive ongoing investigation to determine the root cause of the problem. Heparin is a medically necessary product and serious public health consequences would result if there were a sudden shortage of the drug. Therefore, Baxter and FDA agree that multiple-dose vials of heparin manufactured by Baxter that are currently in distribution will not be recalled. These vials may be used with caution in situations where alternative products are either not available or would be inappropriate for the individual medical situation.

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.

2/11/2008: Baxter's Multiple-dose Vial Heparin Linked to Severe Allergic Reactions. FDA advises health care practitioners to switch suppliers and limit use of drug until problem identified.
The U.S. Food and Drug Administration announced today that Baxter Healthcare Corporation has temporarily stopped manufacturing multiple-dose vials of the injectable blood-thinning drug heparin due to reports of serious allergic reactions and hypotension (low blood pressure) in patients who receive high "bolus" doses of the drug.

Serious reactions to the drug have included difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that can lead to life-threatening shock. Four people have died after receiving heparin, although the relationship to the drug is unclear.

Heparin sodium is derived from pig intestines and has been marketed in the United States since the 1930s. Millions of patients benefit from the intravenous administration of this drug every year to avoid potentially life-threatening blood clots in the veins, arteries, and lungs.

"FDA concurs with Baxter's decision to halt manufacture of heparin sodium in multiple-dose vials," said Janet Woodcock, M.D., FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of its Center for Drug Evaluation and Research. "FDA is vigorously investigating to determine the root cause of these serious reactions associated with the use of heparin made by Baxter. In the meantime, patients and health care professionals who cannot obtain alternative sources of heparin should use caution in administering any Baxter multiple-dose vials that remain."

Heparin is commonly used before certain types of surgery, including coronary artery bypass graft surgery, and in kidney patients before they undergo dialysis. In some situations, heparin treatment is initiated using a high bolus dose given directly into the bloodstream (intravenously) over a short period of time, usually less than one hour. The reported adverse events occurred in patients who were given heparin in this form of administration. There are many other uses of heparin involving lower doses or administration over a longer period of time; adverse events have not been seen with those uses.

About 350 adverse events associated with the Baxter product have been reported since the end of last year compared to less than 100 reports in 2007. Most of the events have taken place at hemodialysis centers, almost exclusively involving patients receiving a bolus dose – which is a high dose administered over a short time. While most of the reports involve multiple-dose vials, several cases include patients who received a bolus dose after their health care professional combined heparin from single-dose vials.

The Missouri Department of Health and Senior Services first notified the Centers for Disease Control and Prevention (CDC) in January of several severe allergic-type reactions to heparin that occurred at a single pediatric hospital beginning in November. The CDC in turn alerted FDA and Baxter, prompting the company's voluntary recall of nine lots of heparin on Jan. 17.

Since then, FDA has learned of adverse events that extend beyond the recalled lots and involve patients receiving heparin for other purposes besides hemodialysis. Recent cases have included patients undergoing cardiac surgery and a specialized blood cell treatment known as photopheresis.

Over one million multiple-dose vials of heparin are sold per month in the United States; half of the vials are manufactured by Baxter of Deerfield, Ill. FDA is currently investigating whether similar events have been seen with other heparin manufacturers.

Physicians, dialysis center staff and health care providers are advised to use an alternate source of heparin or another blood-thinning drug when possible. When only Baxter product is available:

Administer the heparin as an infusion (not a bolus) whenever possible.
Use the lowest dose necessary at the slowest infusion rate acceptable to obtain the desired clinical effect.

Closely monitor the patient for adverse events, particularly hypotension and signs and symptoms of hypersensitivity and ensure that resuscitation equipment is available.

Consider pretreatment with corticosteroids (cortisone type medicines) or antihistamines (drugs that relieve the symptoms of allergic reactions) although it is not known if such pretreatment is effective.

 


 
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