Baxter initially recalled nine lots of heparin sodium injection multi-dose vials on January 17, 2008 as a precautionary measure. Since then there have been 400 reports of adverse reactions, some life-threatening and 4 deaths. 4 deaths that didn’t have to happen.
Baxter and the FDA claimed that removing additional lots and doses of Baxter’s heparin from the market earlier would have created a shortage of heparin and therefore more risk to patients requiring heparin therapy than the increased potential for experiencing an adverse reaction. 400 reports of adverse reactions and 4 deaths sounds more of a risk to me.
According to the Baxter Heparin recall notice, adverse reactions have included abdominal pain, decreased blood pressure, burning sensation, chest pain, diarrhea, dizziness, drug ineffectiveness, dyspepsia, dyspnea, erythema, flushing, headache, hyperhidrosis, hypoesthesia, hypotension, lacrimation increased, loss of consciousness, malaise, nausea, pallor, palpitations, paresthesia, paresthesia (oral), pharyngeal edema, restlessness, vomiting/retching, stomach discomfort, tachycardia, thirst, trismus, and unresponsiveness to stimuli. 400 reports of these adverse reactions and 4 deaths.
The FDA has completed the inspection of the Chinese plant that provides the active ingredient in Baxter’s heparin, but has not determined the cause of the problem. China’s drug safety agency, claims that it enforces strict controls on chemicals used in pharmaceuticals but importing countries are ultimately responsible for ensuring product safety. 400 adverse reactions and 4 deaths since January 17, 2008 because it’s not China’s responsibility to ensure the safety of product manufactured in their country.
China has dozens of heparin manufacturers. Some are classified as pharmaceutical companies and subject to inspections and some companies are not. The Chinese food and drug agency apparently did not inspect the factory because it was registered as a chemicals manufacturer, not as a pharmaceuticals company. How was a company who was obviously producing an active ingredient to a pharmaceutical drug able to register as a chemical manufacturer instead of a pharmaceutical manufacturer and therefore able to bypass inspections? And not be held accountable for 400 adverse reactions and 4 deaths?
The U.S. FDA acknowledged that it never inspected Changzhou SPL, the Chinese manufacturer, contrary to its own regulations, because of what it says was a mix-up with names. It only took 400 adverse reactions and 4 deaths to get that figured out?
On February 28, 2008, 400 adverse reactions and 4 deaths later, Baxter has finally recalled the remaining lots of heparin.