Cancer drug shortage looms, but FDA hopeful

HealthDay

The U.S. Food and Drug Administration said Tuesday it was cautiously optimistic a feared shortage of a life-saving drug used to treat a form of childhood leukemia will be averted.

The drug, methotrexate, is used in combination with other drugs to combat acute lymphoblastic leukemia (ALL), which typically strikes children ages 2 to 5 and is the most common type of cancer in children.

Methotrexate is a linchpin in the treatment of children battling ALL. In high doses the generic drug has cured patients and been beneficial in preventing recurrence. Without it, the chance for a cure is reduced and the risk of recurrence rises.

"We are seeing the companies respond to this shortage, and they are planning on some very large releases, and we are planning on having the situation resolved," said Valerie Jensen, associate director of the FDA's drug shortage program. "Right now, from what we are understanding from the companies, the releases will resolve these shortages. So we are watching this very closely. We are expecting some good releases at the end of this month and continuing into March and beyond."

Oncologists are worried supplies of methotrexate could be gone in as little as two weeks.

One of the four major makers of methotrexate, Hospira Inc., based in Lake Forest, Ill., said Tuesday it had increased production to "make up for the supply gap." The other manufacturers, Mylan Inc. of Canonsburg, Pa., Sandoz US Inc. of Princeton, N.J., and APP Pharmaceuticals of Schaumburg, Ill., said they are working to head off a shortage of the drug.

The shortage began in December when production declined, primarily at Ben Venue Laboratories Inc. in Bedford, Ohio, after federal inspectors cited sterility and equipment problems.

Last year there were a record 267 new drug shortages reported; most remain unresolved. More than half of shortages in 2010 were due to quality issues, such as sterility or drug impurities. With AP