FDA inspects wrong heparin facility

A mere mistake in records may lead to unexpected things. For example, the Food and Drug Administration's Center for Drug Evaluation and Research mistakenly cleared the heparin facility belonging to another company with a similar name.

Photo: FDA inspects wrong heparin facility

Initially, the FDA planned an inspection of Illinois-based Baxter International Inc., following the allegations that it manufactures heparin in multi-dose vials causing dangerously low blood pressure, vomiting and difficulty breathing. Four patients taking the drug died.

Heparin acts as an anticoagulant, preventing the formation of clots and extension of existing clots within the blood. While heparin does not break down clots that have already formed (unlike tissue plasminogen activator), it allows the body's natural clot lysis mechanisms to work normally to break down clots that have already formed. Heparin is used for anticoagulation for the following conditions:

- Acute coronary syndrome, e.g., myocardial infarction

- Atrial fibrillation

- Deep-vein thrombosis and pulmonary embolism

- Cardiopulmonary bypass for heart surgery.

As with many drugs, overdoses of heparin can be fatal. In September 2006, heparin received worldwide publicity when 3 prematurely-born infants died after they were mistakenly given overdoses of heparin at an Indianapolis hospital.