FDA Approves Still More Pain Medication


For decades, chiropractors and acupuncturists have been providing successful treatments for the symptoms of Fibromyalgia. Study after study has shown that an overall wellness program that included Chiropractic adjustments and acupuncture treatments brought relief to individuals suffering from dis­comfort associated with the problem. Now, however, the U.S. Food and Drug Administration has deter­mined that Fibromyalgia may be treated with the drug Lyric, which recently received government approval.

Fibromyalgia is a disorder that is characterized by chronic aches and tenderness in the muscles, fatigue and sleep problems. Pain usually occurs in the neck, shoulders, back, hands and pelvis. While there is no permanent damage to the joints or muscles associated with it, the pain it brings can be quite intense and difficult to live with. It is estimated that between 3 to 6 million people in the United States suffer from it each year. Statistics show that more women than men are affected, typically starting in early-to-middle adulthood.

It is interesting to note from the FDA commentary on Lyrica that while some test patients experi­enced a lessening of pain, not all experienced relief from the product. According to Steven Galson, M.D., the director of FDA’s Center for Drug Evaluation and Research, “Consumers should understand that some patients did not experience benefit in clinical trials. We still have more progress to make for treatment of this disorder.”

Also interesting is that it was approved even though the maker of the drug, Pfizer Inc., and the FDA were not able to provide detailed information of just how it works. According to the FDA, “Individuals with Fibromyalgia have been shown to experience pain differently from other people. Studies have shown that such patients have decreased pain after taking Lyrica, but the mechanism by which Lyrica produces such an effect is unknown.”

Finally, the FDA included the following warning to people using Lyrica: “The most common side effects of Lyrica include mild-to-moderate dizziness and sleepiness. Blurred vision, weight gain, dry mouth, and swelling of the hands and feet also were reported in clinical trials. The side effects appeared to be dose-related. Lyrica can impair motor function and cause problems with concentration and atten­tion. FDA advises that patients talk to their doctor or other healthcare professional about whether use of Lyrica may impair their ability to drive.”

Also interesting is that the FDA made no mention of possible alternative methods for treating Fibromyalgia symptoms. These would include a healthy diet, adequate rest, exercise, stretching of affect­ed areas, physical therapy, Chiropractic adjustments or Acupuncture treatments. It’s also noteworthy that this drug was originally targeted toward handling nerve pain associated with diabetes. When its approval was declined, it was retargeted toward Fibromyalgia pain and thus received FDA approval.

Persons suffering from the symptoms of Fibromyalgia should be thoroughly examined by a chiro­practor and/or an acupuncturist given healthy treatment options. This should be done long before consid­ering a drug that showed marginal test results and requires a slew of FDA warnings to consumers.

Source: The U.S. Food and Drug Administration, June 2007. http://www.fda.govibbs/topics/NEWS/2007/NEW01656.html and http://www.fda.goviconsumer/updates/fibromyalgia062107.html
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  • : DOL 09/15/09 06:46pm

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