NEWSBRIEF: A nonprofit group called Public Citizen is asking the FDA to immediately yank the fibromyalgia drug Savella (milnacipran) off the market. The group's petition says the drug's dangers outweigh its benefits.
The side effects listed by the group include:
- Raised blood pressure
- Increased heart rate
- Suicidal thoughts
The petition also states that Savella offers "only a marginal effect on pain."
Savella became FDA approved for fibromyalgia in 2009. It's a serotonin-norepinephrine reuptake inhibitor (SNRI), similar to Cymbalta (duloxetine), but unique in that it raises norepinephrine more than serotonin. Both of these neurotransmitters are frequently low in people with fibromyalgia.
On its website, Public Citizen describes itself as "a national, nonprofit consumer advocacy organization founded in 1971 to represent consumer interests in Congress, the executive branch and the courts." Its Health Research Group focuses on drug safety and public health.
Public Citizen has criticized Cymbalta over liver toxicity. It's also placed Lyrica (pregabalin) on its "do not use" list for neuropathic pain, saying risks outweigh benefits. Savella, Cymbalta and Lyrica are the only drugs currently FDA approved for fibromyalgia.
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