FDA: Shortage Ends For A Leukemia Drug, But Others Remain
20 Octobre 2011 - 11:00PM
Dow Jones News
The Food and Drug Administration said a shortage of the leukemia
drug cytarabine has been resolved, although record shortages remain
for cancer drugs and medicine used by hospitals for critical
care.
Cytarabine has been in short supply for about a year, but the
shortage became so severe in the spring that even top cancer
centers were unable to get it at times.
Cytarabine is the main treatment for people with acute myeloid
leukemia, or AML, and part of a treatment regimen for other types
of blood cancers. For AML patients, there was no substitute
drug.
Valerie Jensen, the associate director of FDA's drug shortage
program, said production problems at Hospira Inc. (HSP) and APP
Pharmaceuticals, a unit of Fresenius SE (FRE.XE), have been fully
resolved, and that there's currently "really good national supply"
of cytarabine.
In 2010, Hospira had problems getting active ingredient used to
make cytarabine. Then Hospira and APP Pharmaceuticals had problems
with particles in some of the cytarabine vials, which temporarily
stopped shipments of the medicine. The particles turned out to be
tiny clumps of dried active ingredient.
As a stop-gap measure, the FDA allowed the cytarabine to be
shipped with instructions that the vials be warmed to dissolve the
clumps before the drug was administered.
A third manufacturer of cytarabine, Bedford Laboratories,
couldn't keep up with demand while the other firms resolved their
manufacturing problems.
Although the cytarabine shortage is resolved the FDA, companies
and hospitals are still grappling with shortages of other drugs,
including Johnson & Johnson's (JNJ) cancer drug Doxil.
The Food and Drug Administration reported a record 178 drug
shortages in 2010 and has said there's a greater number of
shortages so far this year.
Most of the shortages involve older, generic drugs administered
by injection or intravenously. Along with cancer drugs, they also
include antibiotics to treat infections and nutritional drugs for
patients who can't eat.
Most of the drugs are generic, not highly profitable and are now
made by only one or two companies. Teva Pharmaceutical Industries
Ltd. (TEVA) and Hospira are two of the bigger producers of generic
drugs.
The shortages are growing more severe, in part because of
industry consolidation and manufacturing problems in the past year.
When one company runs into a manufacturing problem with a product
or decides to quit making a drug, competing companies can't quickly
fill the void. In April, Teva reopened a California plant that it
had shut down voluntarily for about a year, in part to retool to
meet Food and Drug Administration manufacturing guidelines.
-By Jennifer Corbett Dooren; Dow Jones Newswires, 202-862-9294;
jennifer.corbett@dowjones.com