Unapproved Morphine Remains on the Market, FDA Rules

By Anna Boyd
14:24, April 10th 2009
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Unapproved Morphine Remains on the Market, FDA Rules

The Food and Drug Administration on March 30 requested manufacturers of 14 medications based on liquid morphine to stop making it. Nine companies were given 60 days to stop making these products and 90 days to stop distributing them, if they wanted to avoid further enforcement action.    

However, on Thursday, the agency said the morphine liquid, which was never approved by the agency, will remain on the market until it’s replaced by an approved version or some equivalent therapy.
 
The decision comes after many doctors treating terminally ill patients had complained that the removal of the morphine from the market would “cause extreme suffering for many patients who are nearing the end of life.”
 
About 2 million people in the US may be treated for pain with the painkilling liquid, called hydromorphine and sold under the name Dilaudid and other brands. Also, many people rely on unapproved pain killers complaining that finding approved versions of the drug is difficult, if not impossible. Hydromorphine may cause respiratory distress and other serious adverse events, including death in patients, if not used properly.
 
“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 alleviation of their pain,” Dr. Douglas Throckmorton, deputy director of the FDA’s Center for Drug Evaluation and Research, said Thursday.



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