FDA and Baxter Heparin

Heparin is an anticoagulant drug produced by Baxter Healthcare. Heparin sodium is used for prevent blood clotting in patients undergoing dialysis, cardiac …

Heparin is an anticoagulant drug produced by Baxter Healthcare. Heparin sodium is used for prevent blood clotting in patients undergoing dialysis, cardiac surgeries (but only certain types) and to treat and prevent medical conditions in similar cases. It is also administered in deep venous thrombosis (DVT) and pulmonary emboli. It was found to be contaminated by over-sulfated chondroitin sulfate in 2008. This contamination resulted in sever side effects such as allergic oral swelling, nausea, vomiting, sweating, shortness of breath, etc. Some patients suffered from bleeding episodes and some even died.

The U.S. Food and Drug Administration (FDA) had alerted healthcare providers of a change in USP (United States Pharmacopeia) monograph for heparin in 2009. Manufacturers were liable for shipping heparin products manufactured and tested according to the new USP monograph. It was aimed at decreasing the potential of contamination and harm due to heparin. In 2008 Baxter recalled Heparin due to the contamination problem. This contaminated lot of heparin was produced at company’s China plant. The Chinese supplier was banned for import.

FDA also asked the manufacturer to label the new packets of heparin according to the new USP. It was done to differentiate the new lot from the older one.

FDA tried to enforce safety through highlighting following points-

Both old and new heparin was allowed to be present in the market simultaneously, to ensure adequate supply. The manufacturer of Heparin was asked to differentiate new and old heparin through lot number.

FDA asked healthcare practitioners to administer the doses of heparin according to potency of both new and old heparin.

FDA stressed on regular PTT and ACT monitoring for potency change.

FDA left the doses for clinical judgment according to patient’s condition.

FDA requested further investigation and study regarding side effects and contamination of heparin produced by Baxter. Study found that heparin sodium made under new USP monograph has 10% less blood thinning capability. The study was targeted to understand the potency changes and its impact in clinical processes in a better way. This study was performed in 2010. Then FDA announced safety information for both patients and healthcare practitioners. It asked patients to consult a doctor before taking heparin.

It asked healthcare practitioners to take care of

  • Potency difference between old and new heparin.
  • Rely on clinical judgment for dose determination according to the condition of the patients.
  • Prescribe doses according to patient’s need on individual basis.
  • Read and understand the heparin label carefully.
  • Differentiate doses for pediatric use and adult use.
  • Report any unusual occurrence or side effects.
  • To use products from other manufacturer or other blood thinning drug when bolus dose of heparin is necessary.
  • Avoid bolus dose, if possible
  • Try to use lowest possible dose at a slow infusion rate
  • Check patients for any side effect closely
  • Consider pros and cons of heparin before giving it to a patient.

FDA has tried to ensure safety of patients using heparin by regulating its production and use. Many complain lack of fund with FDA makes it difficult to monitor all the drugs effectively.