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Last week, a group called Public Citizen sent a letter to the Food and Drug Administration urging them to pull the drug Savella off the market. Savella, which is marketed by Forest Laboratories Inc. and Cypress Bioscience Inc., is used to treat fibromylagia, a disease with "a wide range" of pain-related symptoms, including muscle soreness, headache, fatigue and depression.
According to a report by the Associated Press, last summer European regulators rejected the drug due to lack of effectiveness data and the drug's side effects. Public Citizen feels the FDA should follow suit. Studies have shown that 20 percent of patients taking Savella had hypertension, or high blood pressure, compared with only 7 percent of those taking a placebo.
Further, it is just not clear what pain relief benefit is realized from taking the drug. Again, AP reports that a reanalyzed study showed only 9 percent of patients on Savella significantly reduced their pain, compared with 7 percent of those taking a placebo.
The FDA approval process includes questions regarding whether a company can properly manufacture the proposed drug, the test results for the drug, and the company's proposed label for the drug. The labeling should include uses for which the drug has been shown to be effective, possible risks, and how to use it. Finally, the FDA balances whether or not the drug's benefits outweigh the known risks and side effects. According to Public Citizen, that balance needs to be reevaluated by the FDA.
Other drugs for fibromylagia, Cymbalta and the anti-seizure treatment Lyrica have been cleared by the FDA approval process for treatment of the disease.