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Will the FDA approve chronic fatigue syndrome medication?

Individuals who suffer from conditions that are difficult to document also struggle with getting the right medical treatment they may need to help them cope with their physical and mental pain and suffering.

They may also come across many obstacles when trying to apply for Social Security disability benefits if their doctors are unable to pinpoint their disabling physical or mental disorders. For this reason, many workers who suffer from fibromyalgia, chronic pain or chronic fatigue syndrome choose to consult an attorney when they need to apply for disability benefits or pursue a disability claim.

Conditions like fibromyalgia, chronic pain and chronic fatigue syndrome are especially difficult for some workers to cope with because there are no simple ways to diagnose or treat the conditions. Currently, a drug manufacturer that has developed a medication that is supposed to help alleviate the symptoms of chronic fatigue syndrome is seeking approval from the U.S. Food and Drug Administration to sell the medication in the U.S. Unfortunately, it was reported a couple of weeks ago that the FDA's advisory panel does not believe the drug should be approved.

Many folks who suffer from chronic fatigue syndrome are disappointed in the federal advisory panel's recommendation to not approve Ampligen, which is manufactured by Hemispherx Biopharma Inc. However, this does not necessarily mean that the drug won't be approved. The FDA still gets to make the final decision, which is expected to happen in February.

The advisory panel said that although the drug has helped some folks who suffer from chronic fatigue syndrome, the drug maker was not able to provide enough evidence from its clinical trials to prove that the drug is safe and effective. If the drug is approved by the FDA next month, it could help about 1 million Americans who suffer from chronic fatigue syndrome, which causes severe fatigue, problems concentrating, memory issues and pain in muscles.

One patient who has been taking Ampligen since 1997 claims the drug has been an effective form of treatment. When talking about the drug's effects, the woman said, "It was like rising from the dead." It will be interesting to see what happens next month when the FDA announces whether it will approve the medication.

Source: The Wall Street Journal, "Panel Rejects Drug for Chronic Fatigue Syndrome," Jennifer Corbett Dooren, Dec. 20, 2012

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