MND: Fibromyalgia’s main weaponry seems to be Lyrica (Pregalin). We have posted previously on the topic:

Fibromyalgia Pain :Comparative effectiveness of antiepileptic drugs

MND: It is good news that the arsenal of medications might get an addition: Sodium Oxybate. Click Here for the study by the Pain Journal on Line

MND: After beeing given Sodium Oxybate, study observed:

  • Improvements were reported in
    • pain: “… a 30% reduction in pain was experienced by 54.2% and 58.5%… “
    • fatigue,
    • sleep disturbance
    • function
  •  Possible side effects were :  Headache, nausea, dizziness, vomiting, diarrhea, anxiety, and sinusitis.  Deemed overall safe by the authors.

MND: C ompare with pregabalin, 38% to 50% improvement ; gabapentin, 51%improvement.  Pretty good?

MND: But read this: FDA Panel Says No to Sodium Oxybate for Fibromyalgia, Medscape Today, 2010)

FDA Concerns and objections are mostly about safety, and possibly social and/or criminal use: 

  •   Also known as gamma-hydroxybutyrate, or GHB, sodium oxybate has been called the date rape drug! 
  •   Sodium oxybate is given in 2 doses. After the first dose, the patient falls asleep immediately and then must wake up again 2 hours later to take the second dose, setting an alarm to do so in many cases.
  • Members of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted 20 to 2 against expanding the drug’s current indication for narcolepsy,
  • The case for Sodium Oxybate at the joint meeting of the arthritis and drug safety and risk management Advisory committee, Aug 20 2010

MND: Is Fibromyalgia taken seriously?  or is there still some doubt about it’s cost to the quality of life of  patients severely hit…..After all opioids are on the controlled pharma  market…

FDA contact : Nicole.Vesely@fda.hhs.gov

Talk to your Doctor

 

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