Imports to relieve critical shortage of cancer drugs

Cancer drug shortage

Credit: WFAA

Methotrexate is in short supply because its sole U.S. manufacturer shut down the assembly line.

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by JANET ST. JAMES

WFAA

Posted on February 21, 2012 at 6:00 PM

Updated Tuesday, Feb 21 at 7:51 PM

DALLAS — Thousands of cancer patients are breathing easier after a very unusual move from the Food and Drug Administration.

For now, methotrexate (a drug used to treat pediatric leukemia), and Doxil (which is used by ovarian cancer patients) will be made by foreign companies.

The FDA is temporarily allowing an alternative to Doxil called Lipodox to be imported from India. The Indian pharmaceutical firm already sells products in the U.S.

An Australian manufacturer will provide the preservative-free version of methotrexate needed for cancer treatment. The company makes a current drug with preservatives, but had to update paperwork and meet other requirements in order to provide the preservative-free version.

The crucial cancer-fighting drugs have been in short supply, putting patients in jeopardy of missing lifesaving treatments.

Doctors were only weeks away of completely running out of methotrexate, which is used to fight the most common form of childhood cancer.

"It would have been extremely scary for us to not be able to have the medicines that we needed," said Jill Bott, whose eight-year daughter Brooke was diagnosed with leukemia three years ago. "You don't think about that kind of thing happening in America. It shouldn't happen here."

Experts say the shortage of methotrexate happened when the manufacturing plant in the United States shut down to address quality issues. Because cancer medication often isn't profitable, there wasn't an adequate back-up supplier.

There is a long waiting list of companies that have applied to manufacture generic drugs.

More than 200 medicines were in short supply last year. In some cases, doctors were forced to postpone care or use second-best alternatives.

Oncologists were forced to get creative, making the available drugs stretch.

"It's been a scary time," said Dr. Stan Goldman. "Right now, we have enough drug available, so we're not changing therapy. We're just trying to have patients come at the same day so we can split the vials."

Dr. Goldman, a pediatric oncologist at Medical City Children's Hospital in Dallas, said he's excited that a new supply of methotrexate is being rushed to cancer centers.

"It's a relief," Goldman said. "The real question though is: What's the next drug that may be in short supply?"

There are still nearly 300 drugs on the FDA shortage list. Federal regulators now require companies to alert them when they anticipate problems.

E-mail jstjames@wfaa.com

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