Appeals from hospice experts mean an unapproved drug, one of 14 given recent warning, will remain on the market, agency says,,,,
THURSDAY, April 9 (HealthDay News) -- Bowing to the pleas of hospice experts, the U.S. Food and Drug Administration has backed off its intent to remove from the market an unapproved liquid morphine painkiller given to dying patients.
Dr. Douglas Throckmorton, deputy director of the FDA's Center for Drug Evaluation and Research, told the Associated Press Thursday that the morphine liquid will remain on the market until replaced by an approved version or some other equivalent therapy.
The reversal follows a March 31 FDA warning to nine companies to stop making 14 unapproved prescription narcotic painkillers.
The liquid morphine was one of those painkillers, and is highly concentrated. Throckmorton said health officials had thought that other, more diluted forms of morphine could replace the concentrated one.
But, he told AP, reaction from hospice experts and others "helped us understand" that some patients need the unapproved version.
Dr. Porter Storey, executive vice president of the American Academy of Hospice and Palliative Medicine, called the FDA action "a really important step in the right direction." He added that it showed "an amazing level of responsiveness we're not used to seeing in our government officials," according to AP.
Deborah Autor, director of the Office of Compliance at the FDA Center, told reporters during a March 31 teleconference that the unapproved products posed a risk for consumers. "These include respiratory depression and other serious adverse events, including death," she said.
The batch of warning letters sent at the time was part of an ongoing effort to remove unapproved medicines from the market. Roughly 2 percent of all prescriptions in the United States are filled with unapproved drugs, accor
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