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Drug Notebook

Generic Name: heparin

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A heparins drug clas - used forAnticoagulation During Pregnancy and Deep Vein Thrombosis and treats ... more

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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(HEP a rin)

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.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Your stools may also need to be checked for blood. Do not miss any scheduled visits to your doctor.

Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.

You may be switched from injectable heparin to an oral (taken by mouth) blood thinner. Do not stop using the heparin until your doctor tells you to. You may need to use both the injection and the oral forms of heparin for a short time. Store heparin at room temperature away from moisture and heat.

What happens if I miss a dose?

Contact your doctor for instructions if you miss a dose of heparin.

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.

What should I avoid while using heparin?

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.

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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