The U. S. Food and Drug Administration has reversed its decision to take an unapproved liquid morphine painkiller off the market in acceptance of hospice expert's opinions.
Dr. Douglas Throckmorton, deputy director of the FDA's Center for Drug Evaluation and Research, said that the morphine liquid would continue to be sold in the market until it could be replaced by an approved version or some other therapy that was similar. Liquid morphine painkiller sold in a potent 20-milligram per milliliter strength is given to dying patients who need it to relieve pain. The FDA had told nine companies on March 31 to discontinue marketing of 14 unapproved prescription narcotic painkillers in an attempt to control drugs without proper clearance being on the market and seven of these companies made or distributed liquid morphine.
On March 31, Deborah Autor, director of the Office of Compliance at the FDA Center said that the unapproved products posed a risk for consumers. "These include respiratory depression and other serious adverse events, including death," she said.
"The FDA wants to assure consumers who rely on these products for pain relief that they will still have access to FDA-approved narcotic drugs and there will be no shortage for consumers," Autor told reporters. Throckmorton said health officials had thought that other, more diluted forms of morphine could replace the concentrated one but they reversed the decision after discussions with groups who provide end-of-life care to patients who "helped us understand" that some patients need the unapproved version.
On Thursday, the FDA sent letters to the makers or distributors of liquid morphine telling them they could continue sales for now. Once an acceptable liquid morphine wins approval or the FDA finds an appropriate alternative, sales of the unapproved versions would be stopped. Throckmorton said Thursday that the stop-order for the other painkillers was still in place.
Dr. Porter Storey, executive vice president of the American Academy of Hospice and Palliative Medicine, said the FDA action was "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."
The companies sent warning letters were: Boehringer Ingelheim Roxane Inc., of Columbus, Ohio; Cody Laboratories Inc., Cody, Wyo.; Glenmark Pharmaceuticals Inc., Mahwah, N. J.; Lannett Co., Philadelphia; Lehigh Valley Technologies Inc., Allentown, Pa.; Mallinckrodt Inc. Pharmaceuticals Group, St. Louis; Physicians Total Care Inc., Tulsa, Okla.; Roxane Laboratories Inc., Columbus, Ohio; and Xanodyne Pharmaceuticals Inc., Newport, Ky.
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