Drug Notebook

FDA Alerts

Special Alerts:

[Posted 02/11/2008] FDA informed healthcare professionals of important warnings and instructions for Heparin Sodium Injection use. There have been reports of serious adverse events including allergic or hypersensitivity-type reactions, with symptoms of oral swelling, nausea, vomiting, sweating, shortness of breath, and cases of severe hypotension. 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 sodium is an anticoagulant (blood thinner) that 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 and pulmonary emboli. Heparin treatment is initiated using high doses (5000-50,000 units) given directly into the blood stream (intravenously) as a bolus. Serious adverse events have recently been reported in patients who received these higher bolus doses.

The manufacture of multiple-dose vials of heparin sodium has been suspended pending the completion of an extensive ongoing investigation to determine the root cause of the problem. Because heparin sodium is a medically necessary product and serious public health consequences would result if there were a sudden shortage of the drug, the multiple-dose vials of heparin sodium manufactured by Baxter that are currently in distribution will not be recalled. See the FDA Public Health Advisory for Agency recommendations to healthcare professionals on the use of heparin sodium for injection. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#HeparinInj2, http://www.fda.gov/cder/drug/advisory/heparin.htm, http://www.fda.gov/cder/drug/infopage/heparin/heparinQA.htm and http://www.fda.gov/bbs/topics/NEWS/2008/NEW01797.html.

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heparin
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(HEP a rin)

What is the most important information I should know about heparin?

Before using heparin, tell your doctor if you have high blood pressure, an infection involving your heart, hemophilia or other bleeding disorder, a stomach or intestinal disorder, liver disease, or if you are on your period.

Heparin can cause you to have bleeding episodes while you are using it and for several weeks after you stop. Call your doctor at once if you have easy bruising or unusual bleeding, such as a nosebleed, black or bloody tarry stools, or any bleeding that will not stop. Certain medicines can increase your risk of bleeding while you are using heparin, such as aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) including ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Voltaren), diflunisal (Dolobid), etodolac (Lodine), flurbiprofen (Ansaid), indomethacin (Indocin), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), piroxicam (Feldene), and others. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Women over 60 years of age may be more likely to have bleeding episodes while using heparin.

What is heparin?

Heparin is an anticoagulant (blood thinner) that prevents the formation of blood clots.

Heparin is used to treat and prevent blood clots in the veins, arteries, or lung. Heparin is also used before surgery to reduce the risk of blood clots.

Heparin may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before using heparin?

Do not use this medication if you are allergic to heparin, or if you have:
  • a severe lack of platelets in your blood; or

  • uncontrolled bleeding.

Before using heparin, tell your doctor if you are allergic to any drugs, or if you have:

  • an infection of the lining of your heart (also called bacterial endocarditis);

  • uncontrolled high blood pressure;

  • a bleeding or blood clotting disorder, such as hemophilia;

  • a stomach or intestinal disorder;

  • liver disease; or

  • if you are having a menstrual period.

If you have any of these conditions, you may not be able to use heparin, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Heparin does not pass into breast milk. However, do not use this medication without telling your doctor if you are breast-feeding a baby. Women over 60 years of age may be more likely to have bleeding episodes while using heparin.
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