FDA amends unapproved opioids action

WASHINGTON, April 13 (UPI) -- The U.S Food and Drug Administration says it has amended its March 30 action warning manufacturers to stop producing certain unapproved prescription opioids.

The federal agency says it will temporally allow the continued production, marketing and distribution of one particular type of opioid -- a high concentrate morphine sulfate oral solution.

The FDA said it took last week's action in response to concerns from palliative care patients and healthcare professionals that the original order would cause a shortage of the morphine sulfate oral solution. This product is widely used to alleviate pain in terminally ill patients. The agency says it determined the 20mg dosage form is medically necessary and should remain on the market until an approved alternative becomes available.

"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," said Dr. Douglas Throckmorton, deputy director of the FDA's Center for Drug Evaluation and Research. "In light of the concerns raised by these patients and their healthcare providers, we have adjusted our actions with regard to these particular products."