Mastodon Morphine Concentrated Liquid Receives FDA Approval ~ Pallimed

Thursday, January 28, 2010

Morphine Concentrated Liquid Receives FDA Approval

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The FDA has approved Roxane Laboratories to make concentrated (20mg/ml) morphine liquid for the administration in opioid tolerant patients with moderate to severe acute and chronic pain. 

Others have covered this story including GeriPal, NHPCO (Member-protected link - Why?), and CAPC.  Obviously the hospice and palliative care online communities are welcoming this news given liquid concentrated morphine is an essential tool in good symptom control, especially for patients in the last few weeks of life when swallowing becomes more difficult.

Interestingly, the FDA Press Release says at the end:
"For this formulation of morphine, the manufacturer had to develop a safety program prior to approval to address the known risks of morphine misuse, abuse and overdose."

But there is no link on the FDA site or Roxane to give more information about the safety program.  Given the past concerns about REMS, it would be interesting to see the details of these plans and how they might impact daily hospice care.

And for how the FDA actually reversed course from nearly taking concentrated liquid morphine off the market, you Pallimed readers along with other social media platforms were part of the grass roots support that helped give support to the larger organizations. 

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