Print
Email
SaveGeneric Name: heparin
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.
Drug Info Tools-
Healthline Part D Plan Selector
Medicare's drug plans are subsidized by the US federal government and offered through insurers.
- Basic Info
- Top Questions
- Clinical Info
- Interactions
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
-
demeclocycline (Declomycin), doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).
If you are using any of these drugs, you may not be able to use heparin, or you may need dosage adjustments or special tests during treatment.
This list is not complete and there may be other drugs that can interact with heparin. 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.
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
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.
 |
 |
Advertise | Terms of Use | Privacy Policy