TUESDAY, Feb. 14 (HealthDay News) -- The U.S. Food and Drug
Administration said Tuesday that it was cautiously optimistic that
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
Methotrexate is a linchpin in the treatment of children battling
acute lymphoblastic leukemia. In high doses, the generic drug has
been successful in curing patients and beneficial in preventing
recurrence. Without the drug, a patient's chance for a cure is
reduced while the risk of recurrence rises, oncologists report.
"We are seeing the [three] companies [that make methotrexate] 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," Jensen added. "We are expecting some good releases at the end of this month and continuing into March and beyond."
Oncologists are worried that supplies of methotrexate could be
gone in as little as two weeks.
One of the three makers of methotrexate, Hospira Inc., based in
Lake Forest, Ill., said Tuesday that it had increased production to
"make up for the supply gap."
Thomas Moore, president of U.S. Hospira, said in a news release:
"Hospira is doing everything it can to help bring more product to
market. This includes working with the U.S. Food and Drug
Administration to qualify a second supplier of the drug's active
ingredient to enable increased production. Hospira believes that it
can increase its supply to the market if it can secure additional
methotrexate active ingredient supply."
The other two manufacturers are Mylan Inc., of Canonsburg,
Penn., and Sandoz US Inc., of Princeton, N.J. Both said they are
working to head off a shortage of the drug.
Mylan, in a Tuesday news release, said it has "ramped up its
production in order to try to meet the resulting increased demand.
We are working both on the manufacturing and regulatory fronts to
expedite the FDA regulatory approvals necessary to further increase
capacity to the extent possible to support the additional
Dr. Elizabeth Raetz, an associate professor of pediatric
hematology/oncology at NYU Langone Medical Center in New York City,
said methotrexate is a "critical component of ALL therapy."
The concern is that there is a 90 percent chance for cure of
acute lymphoblastic leukemia, but that's based on the total drug
regimen including methotrexate, Raetz said. "There is a deep
concern that if that key component is eliminated there would be a
reduced chance for cure," she said.
There hasn't been a shortage of the drug at her hospital, Raetz
noted, but many other hospitals across the country have reached a
critical point, and some centers don't have any at all, she
Acute lymphoblastic leukemia is the most common type of cancer
in children. It's a disease that affects white blood cells, which
help to fight infections in the body. Blood cells are produced in
bone marrow. But in leukemia patients, the bone marrow produces
abnormal white blood cells, which crowd out healthy blood cells. In
acute lymphoblastic leukemia, the excess white blood cells are
called lymphocytes or lymphoblasts, according to the U.S. National
Library of Medicine.
The potential shortage of methotrexate is just the latest in a
series of drug shortages that have existed for several years.
In 2011, prescription drug shortages in the United States hit an
all-time high. Last fall, some 200 drug shortages had been
reported, compared to 178 in all of 2010, the FDA reported.
Many of the scarce drugs are injectables, such as cytarabine and
cisplatin, used to treat serious conditions such as cancer. Some
are only given in hospitals and are "absolutely critical," Jensen
said during a news conference in late September.
More than half (54 percent) of shortages in 2010 were due to
quality issues, such as sterility or drug impurities. Some were
caused by delays or manufacturing capacity problems, while 11
percent were caused by discontinuation of a drug and 5 percent
resulted from raw material shortages, Jensen said.
Jensen also said the shortages tend to occur in drugs that
aren't "economically attractive." This could mean that only one
company produces the drug, making it harder to find alternatives if
the supply dries up.
A lot of the problems are tied to generic drugs, health experts
explained, because few manufacturers make them and profit margins
aren't as high as for drugs still under patent protection.
On Oct. 31, 2011, President Barack Obama signed an executive
order designed to help ease the drug shortages. The order directed
the FDA to "take action" to prevent and reduce the worsening
prescription drug shortages.
Specifically, the order directed the FDA to take steps to
require drug manufacturers to report any impending shortages or
discontinuances six months ahead of the shortage. The agency should
also speed up its review of new manufacturing sites, new suppliers
and new manufacturing protocols, and also add more staff to its
drug-shortage office, the order stated.
For more on drug shortages, visit the
U.S. Food and Drug Administration.
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