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Heparin Warning

The U.S. Food and Drug Administration issued a heparin warning on February 11, 2008 regarding the Jan. 17th recall of heparin products from Baxter International. The heparin warning noted that only the following Baxter heparin products were being investigated for possible contamination:

Baxter’s Heparin Sodium Injection multiple-dose vials —

  • 1,000 units/mL concentration, 10 mL and 30 mL vials
  • 5,000 units/mL concentration, 10 mL vials
  • 10,000 units/mL concentration, 4 mL vials

Anti-Clotting Drug

Heparin is an anticoagulant (anti-clotting) drug that is widely used across the United States and around the world. It helps prevent blood clotting and may help reduce a patient's existing blood clots. Heparin is derived from natural sources, including the mucosal lining of the intestines of pigs. The pig intestines used for Baxter heparin are from China.

Adverse Reactions to Heparin

The FDA had received reports of serious reactions to Baxter heparin given intravenously. The reactions included:

  • Hypotension (low blood pressure)
  • Swelling around the mouth
  • Vomiting
  • Nausea
  • Sweating
  • Breathing difficulties

Patients Affected by the Heparin Warning

The FDA's heparin warning noted that most of these adverse reactions developed within minutes of the administration of heparin, usually involving multiple-dose vials. Baxter has temporarily halted the manufacture of heparin sodium multiple-dose injection vials while the FDA is investigating the problem, and patients who are undergoing the following may be affected by the recall:

  • Hemodialysis for kidney failure
  • Cardiovascular surgery
  • Photopheresis
  • Plasmapheresis
  • Treatment for blood clots

Further Heparin Warning Information

If you have concerns about the heparin warning issued by the FDA or if you have been injured by heparin, contact us today to learn more.

Contact a Heparin Recall Lawyer

More Heparin Resources