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FDA Reverses Stance on Removal of Morphine Painkiller
Date:4/9/2009

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, according to the FDA.

"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.

Starting in late March, the companies had 60 days to stop manufacturing these products and 90 days to stop distributing them, Autor added. "FDA expects all manufacturers and distributors of unapproved versions of these products to honor these deadlines and will not tolerate any manufacture or distribution after these deadlines," she said.

The companies getting 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.

Throckmorton said Thursday that the stop-order for the other painkillers was still in place.

More information

For more on unapproved drugs, visit the U.S. Food and Drug Administration.



SOURCES: Associated Press; March 31, 2009, teleconference with Deborah Autor, J.D., director, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, Md.


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