Consumer advocacy group Public Citizen is urging the U.S. Food and Drug Administration to pull fibromyalgia drug Savella (milnacipran HCl) off the market due to concerns about its side effects and effectiveness.
In a letter written earlier this week to the FDA, the group cited a company study on Savella that it says shows that taking this drug increases the risk of higher blood pressure (hypertension) and hardly alleviates fibromyalgia pain when compared to a placebo pill.
Available to consumers by prescription only, Savella was approved by the FDA in January 2009 to treat fibromyalgia, a muscular pain syndrome that is unknown in anatomical cause and characterized by generalized back pain and muscle pain, feelings of general fatigue and tender points.
While it is unknown how Savella specifically improves fibromyalgia symptoms, the drug does inhibit the reuptake of the neurotransmitter norepinephrine, which is believed to be responsible for feelings of joy and has been found to be low in patients with fibromyalgia.
In the letter, Public Citizen noted how the study by Savella co-marketers (Forest Laboratories Inc. and Cypress Bioscience Inc.) showed that the drug only reduced fibromyalgia pain in 9% of patients compared to a placebo pill that reduced pain in 7% of patients.
Additionally, the letter detailed how 20% of the patients who took Savella had hypertension compared to 7% of the patients who took the placebo.
Based on these findings, the group expressed the opinion that Savella should have never been approved by the FDA and should now be recalled.
In addition to Savella, the FDA has approved two other fibromyalgia drugs, Lyrica (Pregalabin) and Cymbalta (Duloxetine HCl).
Patients with fibromyalgia may consider these other fibromyalgia drugs, non-narcotic medications like acetaminophen, aerobic exercise, massage, lidocaine injections and other treatments when managing their symptoms.