FDA OKs unapproved opioid due to shortage

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.