Heparin-a life saving drug for millions of patients to avoid potentially life-threatening blood clots. It is administered intravenously to patients who are in need of a blood thinner in emergency /operating rooms and dialysis centers. However in recent months it’s manufacturer, Baxter International has faced scrutiny regarding its product labeling, adverse effects and some deaths.
On November 17, 2007, the actor Dennis Quaid and his wife brought their 3 day old newborn twins to Cedar-Sinai hospital for treatment for a staph infection. The babies were put on intravenous antibiotics and were expected to recover fairly quickly.
The series of errors began when two pharmacy technicians brought 100 vials of heparin to the pediatric unit. The vials contained not the standard 10 units per millimeter, but 10,000 units per millimeter. Awhile later the twins were unknowingly given this high dosage to flush their intravenous lines. They received another dose about 8 hours later. The two babies started bleeding out of their tubes and soon were rushed to intensive care. After 11 days, they fortunately have made a full recovery. They were lucky.
The nurses and the pharmacy techs admitted that they had not read the labels on the heparin vials .It seems that this facility had multiple failures on the part of its employees to administer safe medication use. In addition, it seems that both the 10 and 10,000 units’ vials both have similar blue labels and mistakes were made in identifying the bottles. However, Baxter International has more to worry about than just labels.
The Federal Drug administration (FDA) has received over 350 complaints of serious allergic reaction associated with heparin in the last two months. Four patients have died, but the link to heparin has yet to be established. In all of 2007 the FDA received only100 reports of problems with this drug. Baxter has now recalled the affected lots and stopped production of heparin.
The investigation is focusing in on the Chinese manufacturing plant that makes the active ingredient for the drug. The FDA admits that it violated its own policies by not inspecting this Chinese plant but gave the green light to Baxter to produce this drug anyway. Now congress is getting involved and wanting answers for the FDA’s inability to monitor not only this drug plant, but the over 700 approved Chinese drug plants that we receive ingredients from. The agency admits that it only has the manpower to inspect 10 to 20 a year. At that rate it will take 40 to 50 years to inspect them all.
Heparin is actually made from pig intestines. Experts agree that when you crush tissue of other organisms that it sometimes causes impurities that can then be processed into the drug you are creating. The manufacturing process does require the end product to be heat-treated to destroy any microorganisms, but it is unknown at this time what happened in this case.