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FDA reverses decision on liquid morphine
In a surprising move, the Food and Drug Administration (FDA) amended a March 30, 2009, action warning manufacturers to stop producing and distributing certain unapproved prescription opioids, including 20 mg/ml morphine sulfate oral solution.
This form of highly concentrated liquid morphine is a common medication used for hospice patients with pain that cannot be controlled with other medications. Concerns raised by hospice and palliative care organizations resulted in the amendment to the list of unapproved medications.
"While the FDA remains committed to ensuring that all prescription drugs on the market are FDA-approved, we have to balance that goal with flexibility and compassion for patients who have few alternatives for the alleviation of pain," says Douglas Throckmorton, MD, deputy director of the FDA's Center for Drug Evaluation and Research.
Other meds aren't affected
Other medications included in the initial warning to cease production are not affected by this amendment. The other pain control products that will no longer be available after July 1 include immediate release tablets containing morphine sulfate, hydromorphone, and oxycodone. There is a concern about potential shortages of opioid painkillers with the sudden withdrawal of all unapproved versions of the medication, says Porter Storey, MD, executive vice president of the American Academy of Hospice and Palliative Medicine. Storey suggests that the FDA consider a slower withdrawal of medications to enable manufacturers to provide a better supply of alternative medications.
For a copy of the warning letters to companies and the products affected go to: www.fda.gov/ cder. Select the March 31 news item "FDA acts to halt marketing of unapproved narcotic medications," then click on the link within the copy to go to the letters.