The Food and Drug Administration has amended its March 30 action, warning manufacturers to stop the production and distribution of certain unapproved prescription opioids, to allow the continued use of a high concentrate morphine sulfate oral solution on an interim basis. The other products affected by the enforcement action are: immediate-release tablets containing morphine sulfate, hydromorphone and oxycodone. The manufacturers of these agents were given 60 days to cease production.
The FDA took this action in response to concerns from patients and health care professionals in the palliative care community that the previous move would cause a shortage of 20mg/ml morphine sulfate oral solution. This product is widely used to alleviate pain in terminally-ill patients, the agency found. Because it has determined that the dosage form is medically necessary, it should remain on the market until an approved alternative becomes available to the patients who need it.
"While the FDA remains committed to ultimately 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 their pain," explained Douglas Throckmorton, Deputy Director of the FDA's Center for Drug Evaluation and Research.
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