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Monday, November, 23, 2009
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A Day to Celebrate! FDA Approves First Drug for Fibromyalgia

Karen Lee Richards
Karen Lee Richards
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Co-Founder of the National Fibromyalgia Assn.

Karen Lee Richards’ career as a writer and patient advocate grew...

Karen Lee Richards

Thursday, June 21, 2007
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Today the FDA announced that Lyrica (pregabalin) has been approved for the treatment of fibromyalgia.  Lyrica, manufactured by Pfizer, is the very first drug ever to receive FDA approval for fibromyalgia.

How Lyrica Works
According to Pfizer, “Fibromyalgia is thought to result from neurological changes in how patients perceive pain, specifically a heightened sensitivity to stimuli that are not normally painful.  Lyrica binds to a specific protein within overexcited nerve cells and works to calm damaged nerves.  This is thought to reduce the level of pain in patients suffering from fibromyalgia, although the exact mechanism of how Lyrica acts in fibromyalgia is not known.”

Effectiveness
Pfizer conducted two randomized, placebo-controlled trials of Lyrica with a total of approximately1800 people.  The results of these trials showed that treatment with Lyrica,
in doses of 300-450 mg per day, reduced pain and improved function in a number of FM patients.  Read the results of the most recent clinical trial.

Side-effects
The most common side effects of Lyrica include dizziness, sleepiness, blurred vision, weight gain, trouble concentrating, swelling of the hands and feet, and dry mouth.  As with most medications, allergic reactions can occur.  Although they are rare, they can be potentially serious.  The FDA advises patients to talk with their doctors about whether using Lyrica will impair their ability to drive.

Approval Marks Turning Point
This is truly a landmark day for the FM community.  Not only is there now a medication developed specifically to address our pain, but receiving FDA approval of a drug to treat fibromyalgia gives an added dimension of legitimacy to the illness.  Those in the medical community who continue to resist accepting FM as a real and debilitating disorder are eventually going to have to acknowledge its existence.

Whether or not you ever choose to take Lyrica; whether or not it works for you––its very approval is a significant turning point.  Hopefully Lyrica’s approval will pave the way for other drugs currently seeking FDA approval for FM.  And no doubt it will prove to be a giant step forward toward gaining fibromyalgia the respect it deserves.

Please join me in celebrating this exciting day!  

FDA News:  FDA Approves First Drug for Treating Fibromyalgia
FDA Consumer Update:  Living with Fibromyalgia, First Drug Approved

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