LINCOLN — An Omaha pediatric hospital received a large shipment of a lifesaving cancer drug Tuesday after federal officials took new steps to ease a national shortage.
The situation is looking less dire, as well, for St. Elizabeth Regional Medical Center in Lincoln.
But officials from St. Elizabeth and Children’s Hospital & Medical Center weren’t ready to declare the emergency over.
Federal regulators said Tuesday they have approved a new methotrexate supplier and will permit Ben Venue Laboratories Inc. to release a batch of the drug produced before that company stopped production late last year because of quality concerns.
U.S. Food and Drug Administration officials said such measures should help ease the critical shortage of the chemotherapy drug, which cures 90 percent of cases of acute lymphoblastic leukemia, the most common cancer in children.
The few U.S. makers of the drug, which is available only generically, so far haven’t kept pace with demand. Local hospitals were scrambling during the past week to find enough methotrexate to treat their patients.
“I think it’s positive that they have approved another supplier that will be manufacturing, obviously, because that will ensure some longevity of the pipeline down the road,” said Dr. Lisa Kwapniowski, Children’s pharmacy manager.
Kwapniowski said Children’s received a 150-gram shipment of methotrexate Tuesday from Australia. Combined with the 31 grams the hospital received late last week, Children’s should have enough of the drug to last about three weeks, she said.
“I think for the immediate future, we’re definitely OK,” she said. “I don’t know far beyond that.”
At St. Elizabeth, an adult patient missed a dose of methotrexate a couple of weeks ago because of the shortage. As of late last week, Dr. Kurt Clyne, director of the St. Elizabeth pharmacy, wasn’t sure the patient would receive a coming treatment, either.
Clyne said Tuesday he now expects a shipment next week of 12.5 grams, enough to administer the patient’s chemo. But he continues to monitor the situation.
“I’ll believe it when I see the product. That’s the bottom line: We’ve got to have the product to treat the patients,” Clyne said. “We hear a lot of expectations from the drug companies, and they don’t always meet those claims.”
He said it’s likely that the expected shipment is part of the batch that Ben Venue produced before shutting down.
Clyne said the FDA’s recent actions bode well.
“For the most part, it looks like this problem is headed toward possible resolution,” he said.
Drug shortages have increased dramatically in the United States over the past six years, particularly for generic injected drugs, which are the workhorses of hospitals but are difficult to make and produce little profit for drugmakers.
The FDA has prevented numerous drug shortages by getting advance notice from manufacturers, with 195 shortages prevented in 2011, mostly late in the year after President Barack Obama gave the FDA additional powers to address the shortages. Still, hundreds of drugs are in short supply.
“A drug shortage can be a frightening prospect for patients,” FDA Commissioner Margaret Hamburg said in a statement. “Through the collaborative work of 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.”
The FDA also said Tuesday said it will temporarily allow importation of a replacement drug for Doxil, a drug for ovarian and other cancers that hasn’t been available for new patients for months.
This report includes material from the Associated Press.
Contact the writer: teresa.lostroh@owh.com
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