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Michael Phelan
Michael Phelan
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Fibromyalgia Drug Approved by FDA

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Fibromyalgia is a disease whose very existence is questioned by some doctors, typically doctors hired by insurance defense lawyers in personal injury cases. However, fibromyalgia must be a real disease, because drug giant, Pfizer, says it is. Pfizer is marketing its drug Lyrica, which is the first drug approved to treat this pain condition. Fibromyalgia is characterized by chronic, widespread pain. Fibromyalgia sufferers typically do not respond to conventional pain killers like aspirin. Lyrica affects the brain and the perception of pain. Advocacy groups estimate that 10 million Americans suffer from fibromyalgia.

The controversy surrounding fibromyalgia is significant. Dr. Frederick Wolfe is the lead author of the 1990 paper that first defined the diagnostic guidelines for fibromyalgia. Dr. Wolfe has switched his position and now believes fibromyalgia is a physical response to stress, depression, and anxiety. He and others point out that there are side effects to Lyrica which include severe weight gain, dizziness, and edema. On the other hand, the American College of Rheumatology, the Food and Drug Administration, and many treating doctors recognize fibromyalgia as a diagnosable condition. Advocates see the FDA’s approval of Lyrica as a milestone toward further legitimizing the diagnoses. Clinical trials for Lyrica showed that half of the patients reported at least a 30% reduction in pain. Those same trial also showed a 7% weight gain which continued over time. The potential for weight gain should be a major concern for any fibromyalgia patient who may already be overweight due to pain-induced inactivity. These issues should be discussed with one’s doctor prior to trying a new drug that has not been subjected to long-term post-market studies.

For more information on this subject, please refer to the section on Drugs, Medical Devices and Implants.