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'Unapproved' morphine to stay on market, FDA rules

  • Story Highlights
  • FDA decides to extend the usage of morphine sulfate oral solution 20 mg/ml
  • Hospital, hospice groups had said pulling drug would cause hardship
  • FDA said until alternatives are developed, easing of pain must remain a priority
  • FDA estimates several thousand drugs marketed without approval
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By Saundra Young
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WASHINGTON (CNN) -- A form of liquid morphine used by terminally ill patients will remain on the market even though it is an "unapproved drug," according to a decision by the Food and Drug Administration.

Last month, the FDA warned nine companies to stop selling unapproved pain-relief drugs.

Last month, the FDA warned nine companies to stop selling unapproved pain-relief drugs.

After talking with hospital and hospice organizations, which expressed concern that taking the product off the market would result in hardship for terminally ill patients and their caregivers, the agency decided to extend the usage of morphine sulfate oral solution 20 mg/ml.

The agency wants to ensure there is no shortage of the drug while patients wait for an approved product to take its place.

"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 a few alternatives for the alleviation of their pain," Dr. Douglas Throckmorton, deputy director of the FDA's Center for drug Evaluation and Research, said Thursday.

"In light of the concerns raised by these patients and their health-care providers, we have adjusted our actions with regard to these particular products."

Last month, the FDA sent warning letters to nine companies telling them to stop manufacturing 14 unapproved narcotics that are widely used to treat pain.

Seven of those companies made or distributed the oral morphine.

The morphine elixir is widely used by terminal patients in hospital and home hospice care settings and is manufactured by Lehigh Valley Technologies Inc., Mallinckrodt Inc. Pharmaceuticals Group, Boehringer Ingelheim Roxane Inc. and Cody Laboratories, Inc.

In its warning letter last month, the agency gave the companies 60 days to stop manufacturing the drug before enforcement action was taken.

Thursday's announcement did not prompt immediate reactions from the companies. A spokesman for Cody Laboratories said the firm did not have all the details of the decision. Other companies did not immediately return calls from CNN.

The FDA estimates there are several thousand drugs, mostly older products, marketed illegally without FDA approval in this country. Once an illegally marketed drug is identified, enforcement action begins because the agency does not have information on the quality of these drugs and has not had an opportunity to approve their labeling. In 1976 the agency began a program to bring companies manufacturing these drugs into compliance.

Thursday's announcement applies only to the morphine sulfate elixir 20mg/ml, and the warning letters sent to the other product manufacturers are still in effect.

Currently there are no approved morphine sulfate oral solution 20mg/ml products on the market. Until there are, the FDA says it will allow companies making and distributing the unapproved drugs to continue, until 180 days after any company receives approval to manufacture a new morphine replacement drug of the same dosage.

The FDA says it expects all companies marketing unapproved drugs to submit the necessary applications to get approval for those drugs.

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