Two deaths involving patients from Beebe Medical Center in Delaware are not their fault, according to Baxter International, makers of Heparin, an anticoagulant drug.
Unlike last year’s product recall, Pfizer provided the key Heparin ingredient that these individuals received, although, the pre-mixed IV bags were completed at Baxter’s Puerto Rican plant.
Last week three patients had to be airlifted from Beebe to other medical centers after suffering intra-cranial bleeding. A 64-year-old woman and a 71-year-old man died over the weekend reported Wallace Hudson, Beebe’s vice president for corporate affairs. The third person’s condition is unknown at this time.
Baxter’s statement claimed the intra-cranial bleeding the victims experienced “was related to underlying medical conditions and risk factors and the Heparin performed exactly as intended, and the events were not related to a quality product issue.”
However, speculation and concern continue since it was only a year ago that Heparin was in the news for conceivably tainted prefilled vials that spanned 12 countries. There was a mass recall after critical, and sometimes fatal, allergic reactions occurred. The Food and Drug Administration determined batches were contaminated with a chemical that indeed caused allergic responses and also low blood pressure in people who received high doses.
Where was the potentially lethal product produced? China. This is another example of poor government oversight, profits before safety, and Chinese involvement.
For the past ten years, the risk of drug contamination has been the primary issue facing the FDA and pharmaceutical industry. The number of overseas facilities producing American drugs proliferated during the Bush Administration…so quickly that it was dubious whether any of those plants would be inspected by the FDA. Future Heparin recipients were at an even greater risk.
In sworn testimony to Congress, Baxter’s CEO lamented that the company should have known better than to delegate the safety of such a pharmaceutical to the Chinese. He professed regret and responsibility since Baxter’s name was on the product.
This time around, Baxter is unequivocally denying any responsibility related to Heparin and the two patient deaths. Little consolation for the grieving families.
Hundreds of thousands of our sickest people rely on Heparin to stay alive…from dialysis patients to those needing cardiac and other surgeries. One might ponder the risk of side effects but contamination is inexcusable and criminal when there are few options.