TUESDAY, Feb. 21 (HealthDay News) -- The U.S. Food and Drug
Administration announced Tuesday what it called a series of steps
to ensure the continued availability of vital cancer drugs that
have been in dangerously short supply.
One of the drugs, methotrexate, is used in combination with
other drugs to combat -- and in many cases cure -- acute
lymphoblastic leukemia (ALL), the most common type of cancer in
children. It typically strikes kids aged 2 to 5.
And another drug, Lipodox, will be temporarily imported from a
pharmaceutical company in India to ease a shortage of the
chemotherapy drug Doxil (doxorubicin), which is used to treat
ovarian cancer, multiple myeloma and AIDS-related Kaposi's sarcoma.
Lipodox is similar in chemical makeup to Doxil; there are no
generic versions of Doxil.
"Through the collaborative work of [the] FDA, industry and other stakeholders, patients and families waiting for these products or anxious about their availability should now be able to get the medication they need," FDA Commissioner Dr. Margaret A. Hamburg said in a news release.
The FDA also said it was issuing guidelines to the drug industry
that spell out detailed requirements for "both mandatory and
voluntary notifications" to the agency of potential problems that
could result in a drug shortage or supply disruption.
Methotrexate is a cornerstone in the treatment of children with
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 said.
Some cancer doctors had warned last week that supplies of
methotrexate could be exhausted within two weeks.
To offset the shortage of methotrexate, the FDA said Tuesday
that it has worked with several drug manufacturers to help maintain
supplies to meet all patient needs. Preservative-free methotrexate
is needed for the intrathecal (injection into the fluid surrounding
the brain and spinal cord) treatment of children with ALL, the
The FDA said the steps taken with methotrexate included
approving a preservative-free version of the generic drug
manufactured by APP Pharmaceuticals, of Schaumburg, Ill. Those
supplies should become available in March and continue
indefinitely, the agency said.
Second, Illinois-based Hospira Inc., which already manufactures
methotrexate, has sped up additional supplies, producing 31,000 new
vials of the drug -- enough for more than one month's supply. Those
additional vials are being shipped Tuesday to hundreds of U.S.
hospitals and treatment centers, the FDA said.
The FDA also noted that it continues to work with other
manufacturers of methotrexate that have also stepped up production.
Those manufacturers include Mylan Inc., of Canonsburg, Pa., and
Sandoz US Inc., of Princeton, N.J.
At a midday news conference Tuesday, one of the speakers was
Sara Stuckey, mother of 6-year-old Nate Stuckey, who has been on
methotrexate since he was diagnosed with ALL in 2009.
"It is hard enough to hear your child has cancer, but to hear that the treatment that is successfully working is suddenly not available is devastating," she said. "My husband and I pray the recommended drugs to fight his cancer will be available when it's time for Nate's next treatment. And we hope that in the future no more families have to go through the stress of wondering whether proven, lifesaving treatments will be out of reach when they need it the most."
Speaking at the news conference, Hamburg said: "There are too
many families like the Stuckeys who worry they won't have the
medication they need for their next treatment and are
understandably anxious about switching to a medication that may
have more side effects or may be less effective. Clearly this is
"We are making progress," Hamburg added. "There were 195 drug shortages prevented in 2011 and 114 drug shortages prevented since October 2011 when we made the call for early notification" of potential shortages.
As for the ovarian cancer drug Lipodox, the FDA said it will
allow the temporary importation of the drug made by Sun Pharma
Global FZE. The agency said in its news release that "temporary
importation of unapproved foreign drugs is considered only in rare
cases when there is a shortage of an approved drug that is critical
to patients and the shortage cannot be resolved in a timely fashion
with FDA-approved drugs."
The shortages of methotrexate and Doxil are 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," Valerie
Jensen, associate director of the FDA's drug shortage program, said
during a news conference last September.
More than half (54 percent) of shortages in 2010 were due to
quality issues, such as 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 brand-name drugs still under patent
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 worsening
prescription drug shortages.
In response to Tuesday's announcement, Dr. Armand Keating,
president of the American Society of Hematology (ASH), said in a
statement: "ASH is encouraged by the steps FDA is taking to
alleviate drug shortages that have significantly affected so many
patients with hematololgic malignancies under our members' care.
The measures announced today are consistent with the Society's
recommendations to FDA, Congress and the Obama Administration to
expand the agency's authority to prevent drug shortages by
requiring manufacturers to provide early notification of impending
shortages and importing drugs in critical supply."
"While ASH applauds the specific actions announced today," Keating added, "we also realize that these measures represent only a portion of a solution to a much larger problem. In addition to these steps, additional measures -- such as developing a national drug registry and providing economic incentives to manufacturers to produce a steady supply of generics -- must be implemented to permanently prevent shortages. Until a complete solution is in place, treatment will be delayed and care will be rationed for critically ill patients."
For more on drug shortages, visit the
U.S. Food and Drug Administration.
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