Heparin Recall Lawsuit

Heparin Class Action Lawsuit Information

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.

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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.

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Questions on Baxter Heparin Sodium Injection

Q. What has FDA recently announced about heparin?

A. Adverse events, including deaths, have been associated with the use of heparin, a blood-thinning drug that contained active pharmaceutical ingredient (API) from China. In February 2008, Baxter Healthcare Corporation recalled multi-dose and single-dose vials of heparin sodium for injection as well as HEP-LOCK heparin flush products. After launching a disciplined, methodical examination, FDA scientists have identified a previously unknown contaminant in the heparin. The agency does not have proof that this contaminant is causing the adverse events. There is an association, but not a direct causal link at this time. The agency has made available information on two tests that FDA scientists have conducted to detect the heparin-like substance, and recommend their use to manufacturers and suppliers for screening the heparin API.

Q. What steps has FDA taken?

A. 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 is medically necessary and Baxter heparin is the only heparin product available.
• Launched a far-ranging investigation in the United States and abroad.
• Inspected a New Jersey facility to find out whether the heparin could have been contaminated by its packaging.
• Traveled to China to perform a thorough check of the plant that manufactures the heparin ingredient.
• 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. 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 there exists a safe and adequate supply of heparin to the U.S. market.

Q. What kind of testing did FDA scientists conduct?

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

Q. What were the results of the testing?

A. FDA scientists determined that the sampled products contained 5 percent to 20 percent of a heparin-like compound—a contaminant that mimicked heparin activity so closely that it was not recognized by routine testing.

Q. How did the contaminant get into the product?

A. 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.