REMS er opiod rx

[mdvol]

---

Members do not see this ad.

Anyone with insights on this from the FDA today?

 

[PMR 4 MSK]

Doctors are stupid an incapable of making important decisions like this themselves. They need government guidance on deciding who is the best qualified doctor to decide who is the best qualified patient to receive opioids.

🙄🙄🙄

 

[lobelsteve]

Anyone with insights on this from the FDA today?

Worthless *****s.

They left off hydrocodone, demerol, and a few other opioids.

From the FDA:

On February 6, 2009, the Food and Drug Administration (FDA) sent letters to manufacturers of certain opioid drug products, indicating that these drugs will be required to have a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drugs continue to outweigh the risks. (Opioid REMS Meeting Invitation Template PDF document; Opioids Products Chart. The affected opioid drugs include brand name and generic products and are formulated with the active ingredients fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone. The FDA has authority to require a REMS under the Food and Drug Administration Amendments Act of 2007 (FDAAA) when necessary to ensure that the benefits of a drug outweigh the risks.

I think they are looking to make hydrocodone the most Rx'd drug ever and also try and kill off some livers and kidneys by limiting access to the other drugs.

 

[geauxg8rs]

The FDA would rather have a bunch of GI bleeders from the Buckets of Naprosyn they will lets us prescribe.

 

[Tenesma]

i am not sure i quite understand this ---- it looks like REMS will monitor drug companies, i don't see where it states that doctors can't rx opioids... enlighten me.