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
(HEP a rin)

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.

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What is the price of this medication and similar alternatives?

This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Heparin Sodium Porcine) 1000UNIT/ML Solution (ABRAXIS PHARMACEUTICALS10/$6.42 or 30/$34.56
Heparin Sodium Porcine) 10000UNIT/ML Solution (ABRAXIS PHARMACEUTICALS125/$403.76 or 375/$1154.51
Heparin Sodium Porcine) 10000UNIT/ML Solution (ABRAXIS PHARMACEUTICALS25/$185.14 or 75/$481.36

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What are the possible side effects of heparin?

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, blood in your urine or stools, black or tarry stools, or any bleeding that will not stop.

Get emergency medical help if you have any of these signs of an allergic reaction: nausea, vomiting, sweating, hives, itching, trouble breathing, swelling of your face, lips, tongue, or throat, or feeling like you might pass out..

Some people receiving a heparin injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel nauseated, light-headed, sweaty, or short of breath during or after a heparin injection.

Stop using heparin and call your doctor at once if you have any of these serious side effects:

  • sudden numbness or weakness, especially on one side of the body;

  • sudden headache, confusion, problems with vision, speech, or balance;

  • pain or swelling in one or both legs;

  • trouble breathing; or

  • fever, chills, runny nose, or watery eyes.

Less serious side effects may include:

  • mild pain, redness, warmth, or skin changes where the medicine was injected;

  • mild itching of your feet; or

  • bluish-colored skin.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

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How should I use heparin?
Heparin is given as an injection into your skin or through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be given instructions on how to use your injections at home. Heparin must not be injected into a muscle. Do not use this medicine at home if you do not fully understand how to give the injection and properly dispose of needles and other items used in giving the medicine. Use each needle and syringe only one time. With your medicine you will receive a puncture-proof container for used needles and syringes. If you do not receive a container, ask your pharmacist for one. Keep this container out of the reach of children and pets. Your pharmacist can tell you how to properly dispose of the container.

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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.

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What happens if I miss a dose?
Contact your doctor for instructions if you miss a dose of heparin.

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What other drugs will affect heparin?
Before using heparin, tell your doctor if you are using any of the following drugs: another blood thinner, such as warfarin (Coumadin); salicylates such as aspirin, Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others; dipyridamole (Persantine); nicotine cigarettes, gum, lozenges, or skin patches; cold, allergy, or sleep medications (Allerest, Benadryl, Chlor-Trimeton, Dimetapp, Sominex, and others); hydroxychloroquine (Plaquenil, Quineprox); digoxin (digitalis, Lanoxin, Lanoxicaps); or

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Can I take this if I am pregnant or trying to get pregnant or if I am breastfeeding?

Heparin has been assigned to pregnancy category C by the FDA. Animal studies have not been conducted and there are no controlled data in human pregnancy. It does not cross the placenta due to its large molecular weight (3,000 to 30,000 daltons). Heparin is considered the anticoagulant of choice during pregnancy, although anticoagulation and maternal disease state may pose a risk to both the mother and fetus. Heparin should be given during pregnancy only when need has been clearly established.

Early studies evaluating the safety and efficacy of heparin in pregnancy suggested heparin offered no advantage over other anticoagulants. However, these studies failed to recognize maternal comorbid conditions as possible risk factors for adverse pregnancy outcomes. Exclusion of these cases resulted in more favorable outcomes in the heparin treated patients. In a retrospective cohort study of 100 pregnancies in 77 women treated with heparin, the rates of prematurity, spontaneous abortions, stillbirths, neonatal deaths, as well as congenital abnormalities were not significantly different than those in the normal population. In addition, there was no evidence of increased risk of maternal complications such as bleeding with heparin when compared to the normal population. A medical literature review found similar results. When pregnancies associated with comorbid conditions as independent risk factors and pregnancies complicated by prematurity were excluded, outcomes in heparin treated pregnancies were not significantly different from the normal population. Several studies have evaluated the risk of osteoporosis in women treated with long-term heparin therapy. Symptomatic osteoporosis is uncommon, but reductions in bone density are well documented. The clinical significance of this remains to be determined. Neonatal osteopenia has not been noted.

Heparin is not excreted into human milk due to its large molecular weight (3,000 to 30,000 daltons). Heparin is considered compatible with breast-feeding.

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Who should NOT use this medication?

  • Uncontrollable bleeding, unless such bleeding is secondary to disseminated intravascular coagulation.
  • Severe thrombocytopenia.
  • Inability to perform suitable blood coagulation tests at required intervals in patients receiving full-dose therapy. Lack of such tests generally is not a contraindication for fixed low-dose therapy, since monitoring of coagulation tests usually is not required.
  • Known hypersensitivity to heparin or bisulfites (in certain IV solutions). Hypersensitivity to corn products (solutions containing dextrose). (See Sensitivity Reactions under Cautions.)

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What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include easy bruising, nosebleeds, blood in your urine or stools, black or tarry stools, or any bleeding that will not stop.

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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.

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Can I stop taking the medication if I feel better?
As a general rule, you should always take your medications exactly as prescribed and do not change the dosage or stop taking the medication without first discussing it with your healthcare provider.

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I am on so many medications; do I have to take them all?
This is called polypharmacy—many different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.

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Where can I get more information?
More Information

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