The FDA has amended its March 30, 2009 action warning manufacturers to stop the production and distribution of certain unapproved prescription opioids. This action is in response to concerns from healthcare professionals and patients in the palliative care community that the March 30 action would cause a shortage of high concentrate morphine sulfate oral solution, a product widely used to alleviate pain in the terminally ill. The FDA has determined this dosage form to be medically necessary and should remain on the market until an approved alternative becomes available.
The other products included in the March 30 action (immediate release tablets containing morphine sulfate, hydromorphone, and oxycodone) are not affected by this amendment.
For more information visit www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ucm133350.htm.