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Jan. 23, 2010
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:
- Risk of suicide
- Serotonin syndrome
- Increase in blood pressure
- Increase in heart rate
- Increase in seizures
- Hepatotoxicity
- Physical dependence and withdrawal symptoms
- Hyponatremia (low blood sodium)
- Abnormal bleeding
- Activation of mania
- Urethral resistance
- Testicular and ejaculation problems
- Controlled Narrow-Angle Glaucoma: Mydriasis (prolonged dilation of pupil)
- Aggravation of liver disease with alcohol use
- Increased fracture risk
- Hazard to the fetus and newborn
- Hazard to nursing infant
- Risk to those with renal impairment
- Interactions with other drugs
- Gastrointestinal disorders
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.
At FM/CFS/ME RESOURCES we've polled our visitors asking:
A resounding 91% of the people answering this question answered, "Yes, But I Quit It ".
Only 10% answering said they're still on Savella.
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