Monday, September 28, 2009

FDA No Longer Includes Description of Adverse Event / Side-effects

Since I started to post the FDA Adverse Events relating to Synvisc reported to the FDA via patient and/or physician, they have since removed the ACTUAL DETAILS and DESCRIPTIONS of the events!!! They simply say "injury" or "hospitilized" or "intervention required."

Patients have the right to know what COULD happen to them if they take Synvisc or ANY OTHER drug or medical device. The FDA SHOULD be working for the people and that would mean full disclosure and description of adverse events.

I'll let you know if the FDA formate changes for the MAUDE search site and see if this changes with the "technical difficulty" declaration. I'll let you know when and if it does change.

4 comments:

  1. I have noticed the same and wonder why the FDA chose to go this way.
    Taking out the descriptions completely changes the understanding of the damages done in most cases.

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  2. I totally agree David. This is a huge change for the FDA that doesn't help the consumer AT ALL.

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  3. My Mother is suffering from what I think is a Synvisc related reaction. She received the shots last year and this year and 3 weeks after the injection she became so sick. She is currently unable to work and has severe pain throughout her body. She also complains of being extremly fatigued from minor tasks. last year we thought she had a severe case of phnomenia but now after research and ruling out anything major through her MD and pulmonolgist I really think its the shots. Anyones elses coments or thoughts would be appreciated.
    Tricia

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  4. Tricia,

    Sadly your mother's injury/reaction sounds very similar to mine and others I'm in contact with. From those I'm in contact with and taking my own experience into account, it is not a quick trip back to health.

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