Friday, January 22, 2010

Savella Raises Concerns at Public Citizen

Public Citizen has ased the FDA pull the fibromyalgia drug Savella from the market.Savella belongs to a class of drugs called serotonin and norepinephrine reuptake inhibitors (SNRIs), which include some antidepressants.

In its petition to the FDA, Public Citizen said that the European Medicines Agency (EMEA), which regulates drugs on the Continent, rejected Savella's approval for fibromyalgia in July 2009, stating that its benefits were "marginal." This was shortly after the FDA approved the drug in January 2009.

Since the drug went on the market in the U.S., approximately 250,000 prescriptions have been filled, with doctors writing more prescriptions every month.

Savella, also known by its generic name milnacipran, was found in two studies to possiblly increase blood pressure, heart rate and suicidal thoughts.