Public Citizen is asking the FDA to take Savella off the market. Savella is a drug used to treat fibromylagia, a tough disease that doctors have a difficult time solving that causes a host of maladies including muscle soreness and pain, headache, fatigue and depression.
Public Citizen’s beef with Savella? Essentially, this consumer watchdog argues that Savella just does not work and it causes high blood pressure. With respect to causing high blood pressure in some patients, this is set forth very clearly on Savella label as well as the increased risk of suicidal behavior.
The manufacturers of Savella, as you can imagine, disagree. They contend that the safety and efficacy of Savella was clear established in clinical trials and that the risk of high blood pressure is worth the benefits of Savella.
There are no lawsuits yet involving Savella and, regardless of who is right here or even if there is an eventual recall because post-marketing data finds the clinical trial findings to be false, I don’t think there is going to be any litigation involving Savella.