NEW YORK (AP) — An Ohio drugmaker has recalled three production lots of cytarabine, a drug that is critical in treating leukemia but which has been in short supply because of previous recalls, the Food and Drug Administration disclosed Thursday.
Bedford Laboratories issued the voluntary recall last month because of concerns about sterility. It said no side effects have been reported, but an investigation of the manufacturing area found there was an elevated risk that the sterility of the drug could not be assured. The three production lots expire from March to May of 2014.
Cytarabine is a popular chemotherapy drug that is irreplaceable in fighting certain types of leukemia. Several other manufacturers stopped making the drug because of quality problems or a shortage of raw materials, which created a shortage of cytarabine.
Bedford Labs runs one of the largest manufacturing plants of sterile injectable drugs. It stopped producing cytarabine in November because it discovered that maintenance and testing of some of its equipment was overdue. It resumed production in the first quarter.
Recalls and manufacturing problems have also created shortages of two other popular cancer drugs: Doxil and preservative-free methotrexate. Doxil is used in the treatment of ovarian and other cancers, and preservative-free methotrexate is used against acute lymphoblastic leukemia, the most common type of cancer in children. Up to 90 percent of children treated with ALL are cured after treatment with methotrexate.
In February the FDA approved additional sources for the drugs in order to deal with the shortages.
