The US consumer watchdog group Public Citizen has petitioned the FDA to immediately ban Forest Laboratories and Cypress Bioscience's SNRI Savella (milnacipran HCl) for the management of fibromyalgia, claiming the drug has "highly questionable" clinical efficacy and has been found, in randomised controlled trials, to cause a large number of potentially serious adverse reactions including hypertension, increased heart rate, and increased suicidal ideation.
The petition further alleges that Savella is a drug that produces only a marginal effect on pain, the main problem for which patients seek treatment.
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