Baxter International Inc announced yesterday, Thursday 28th February, that it was recalling all remaining multi-dose and single-dose heparin sodium and HEP -LOCK heparin flush products now that alternative suppliers are able to meet national demand for them.
Heparin sodium is a vital ingredient in surgical and medical procedures that has been used throughout the US since the 1930s. It is injected into millions of Americans every year to stop potentially fatal blood clots in their veins, arteries and lung. The drug is made from the lining of pig intestines and most of it comes from China.
The announcement was in a statement released by the US Food and Drug Administration on behalf of the drug company.
This follows the recall in January of nine lots of Baxter’s heparin sodium injection multi-dose vials as a precautionary measure after hundreds of patients had severe allergic reactions, and also four patients died, after receiving the product. The drug company also stopped making the product pending a fuller investigation.
The FDA has since admitted that a Chinese plant that supplied Baxter with the heparin active ingredient, which is made from pigs’ intestines, was not inspected by the agency. The agency said it had confused the supplier with another similarly named Chinese supplier on its database that had already been approved.
The HEP-LOCK heparin flush (used to flush intravenous lines and equipment to prevent blood clots) and single dose heparin sodium vials were not recalled because they had not been linked to the adverse reactions and it was essential to keep supplies of this vital ingredient flowing until the demand could be met by an alternative source.
Baxter produces nearly half the US demand for heparin used in operating rooms, dialysis centers and other critical care areas. Pulling their products before an alternative source was found would have “created more risk to patients requiring heparin therapy than the increased potential for experiencing an adverse reaction”, said the FDA.
The agency has concluded there is now sufficient capacity from other suppliers and has given Baxter the go ahead to recall its remaining heparin sodium injection and heparin flush products.
According to Sandra Kweder, deputy director of FDA’s Center for Drug Evaluation and Research, the only Baxter products that are still on the market use heparin sourced from a different supplier. These products contain heparin in premixed IV solution bags and have not been associated with adverse events.
Exactly how the patients came to have allergic reactions to the affected products is still a mystery. The FDA has sent two officers to China where an initial investigation found problems linked to incomplete removal of impurities, plant conditions and management of waste.
According to the Washington Post, Michael Rogers, director of the FDA’s field investigation division, said that while the agency was concerned about what the investigators observed at the plant, it was not linking these concerns to the adverse events associated with Baxter’s products.
The full Baxter product recall now comprises:
- Heparin sodium injection 1000 units/mL 10mL and 30mL multi-dose vials.
- Heparin sodium injection 5000 units/mL 10mL multi-dose vials.
- Heparin sodium injection 10,000 units/mL 4mL multi-dose vials.
- Heparin sodium injection 1000 USP units/mL single-dose vials.
- Heparin sodium injection 5000 USP units/mL single-dose vials.
- Heparin sodium injection 10,000 USP units/mL single-dose vials.
- All preserved and preservative-free 10 USP units/mL and 100 USP units/mL vials of HEP-LOCK and HEP-LOCK U/P.
The recall excludes Baxter’s bagged heparin pre-mix IV solutions of heparin sodium in 5 per cent dextrose injection and heparin sodium in 0.9 per cent sodium chloride injection, said the company.
President of Baxter’s Medication Delivery business, Peter J Arduini said:
“We have assurance from the US Food and Drug Administration that there is an adequate supply in the market to meet the demand for these critical and lifesaving drugs.”
“The safety and quality of our products is always our highest priority, and we will continue to collaborate with the FDA as we work to determine the cause of the increased rate of adverse reactions and resolve this issue,” he added.
Sources:FDA, Washington Post, USA Today.
Written by: Catharine Paddock, PhD