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Entries in Methotrexate (2)

Tuesday
Feb212012

FDA Efforts Reversal of Critical Cancer Drug Shortage

iStockphoto/Thinkstock(WASHINGTON) -- The U.S. Food and Drug Administration approved new suppliers for two cancer drugs Tuesday in an effort to curb the largest nationwide drug shortage in nearly a decade.

The FDA said its approval of a new supply method would increase production of the injection form of the drug methotrexate, which is used to treat children with the most common form of childhood leukemia.

The agency also said it would allow temporary foreign imports of the cancer drug Lipodux, an alternative to the drug doxorubicin, sold under the name Doxil, which is used to treat ovarian cancer, multiple myeloma and AIDS-related Kaposi's sarcoma. Temporary foreign importation is a rare move for the agency.

"In different circumstances we have to apply different tools," said FDA Commissioner Peggy Hamburg in a statement, adding that the quality of the drug was evaluated by the agency before its temporary approval.

The FDA's actions follow President Obama's executive order issued in October 2011 to reduce the dire drug shortage. The order instructed the FDA to broaden its reporting of potential drug shortages, expedite regulatory reviews that can help prevent shortages and investigate whether potential shortages have led to price gouging.

The drug shortage has compromised or delayed care for some patients and may have led to otherwise preventable deaths, say many oncologists.

All five pharmaceutical companies that make the injection drug methotrexate, which treats acute lymphoblastic leukemia by slowing the growth of cancer cells, have either slowed or stopped manufacturing of the drug, according to the FDA. The companies have blamed shortages on high demand or manufacturing delays.

Drug manufacturers APP Pharmaceuticals and Hospira Inc. announced at the press briefing Tuesday that within four to six weeks, both companies would have made enough methotrexate, including the preservative-free form, to meet the nationwide demand.

Next week Hospira plans to release 34,000 vials of methotrexate, or a month's supply of the drug, Michael Ball, CEO of Hospira Inc., told reporters at Tuesday's briefing.

According to Michael Link, a pediatric oncologist and president of the American Society of Clinical Oncology, some hospital pharmacies reported having only a couple of weeks of supplies left.

Many oncologists are especially worried about the shortage of the preservative-free form of methotrexate, which is considered less toxic.

Only the preservative-free methotrexate can be injected into the spinal fluid of cancer patients to prevent the spread and recurrence of the disease.

"There are couple other drugs that can be injected into the spinal fluid, but none that are as effective," said Link. "As for the high dose version of the drug, there's no workaround for it."

Copyright 2012 ABC News Radio

Tuesday
Feb142012

Shortage of Child Leukemia Drug Could Be Avoided, FDA Says

iStockphoto/Thinkstock(WASHINGTON) -- The U.S. Food and Drug Administration said Tuesday that a shortage on the life-saving drug used in childhood leukemia treatments could be averted.

Last week, doctors spoke out about the looming shortage of methotrexate -- a key drug known to help cure some young patients with pymphoblastic leukemia when combined with other drugs in high doses.  Some oncologists expressed worry the drug may run out in as little as two weeks, HealthDay reports.

But Tuesday, the FDA showed more optimism.  

"We are seeing the 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," Valerie Jensen, associate director of the FDA's drug shortage program, said Tuesday, according to HealthDay.

Hospira, one of the three manufacturers of the drug based in Illinois, has said the company will boost production of the drug to "make up for the gap," HealthDay reported Tuesday.  The other two makers of the crucial drug -- Mylan Inc. in Pennsylvania and Sandoz US Inc. in New Jersey -- both say they also plan to increase methotrexate production.

Copyright 2012 ABC News Radio







ABC News Radio