Both drugs have been in increasingly short supply since an Ohio plant shut down last year because of quality control problems.
“We now have available supplies and we will continue to see an increase in numbers over the weeks to come,” Hamburg said during a press conference, referring to methotrexate. “We believe we will be able to meet the needs of patients on a continuing basis. This should resolve the shortage.”
Michael Ball, chief executive of Illinois manufacturer Hospira, said the company yesterday began shipping 31,000 units of methotrexate -- enough to meet the country’s demand for a month. It plans to ship another month’s supply next week.
The FDA rushed through a request by another drugmaker, APP Pharmaceuticals, to begin production of the preservative-free version of the drug and granted that request on Friday. APP is expected to begin shipping the drug in March.
Hospital pharmacists around the country had been counting their remaining supply of methotrexate in weeks as the shortage of the drug worsened. A treatment protocol that includes methotrexate, pioneered in Boston by Dr. Sidney Farber, has turned acute lymphoblastic leukemia, or ALL, from a fatal disease to one that is frequently curable.
Julie Jette, spokeswoman for Floating Hospital for Children at Tufts Medical Center, said the hospital has enough methotrexate to last at least through the end of the month and is expecting a shipment in March, though she did not know whether that was the result of ramped up production.
“We haven’t had to turn any kids away,” she said.
I have asked Children’s Hospital Boston and Massachusetts General Hospital for information about their supply, and will update when I hear back.
At the FDA’s press conference today, Sara Stuckey of Lincoln, Ill., talked about what the shortage has meant for her family. Her 6-year-old son, Nate, was diagnosed with ALL in 2009. He receives a dose of methotrexate every three months. Last week she was told that Nate would receive one more dose. After that, it was not clear whether the drug would be available, she said.
“It’s 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. “We hope that in the future no more families have to go through the stress of wondering whether proven life-saving treatment will be out of reach when they need it the most.”
Dr. Len Lichtenfeld, deputy chief medical officer for the American Cancer Society, said the FDA had taken “major steps forward” in alleviating the shortages but more was necessary. He and others representing major cancer organizations called for a strengthened FDA and improved reporting about shortages from drugmakers.
Hamburg said her office is supporting efforts to create a drug-tracking database and urging drugmakers to report any reductions in production ahead of time, even if they are not required to do so under federal regulations.
