FDA Petitioned To Remove Fibromyalgia Drug
8 CommentsBy Ed Silverman // January 20th, 2010 // 5:47 pm
Which one? Public Citizen says the agency should yank Savella immediately because its dangers outweigh its benefits, according to a petition the consumer group sent the agency. In its missive, Public Citizen notes the European Medicines Agency rejected the drug for fibromyalgia last July, citing marginal benefits that failed to outweigh risks. The FDA approved the drug in January 2009.
In two randomized clinical trials, Savella, which is made by Forest Labs and Cypress Bioscience, was found to increase blood pressure, heart rate and suicidal thoughts, according to the petition. Among patients who had normal blood pressure at the beginning of the study, 19.5 percent of those given Savella developed hypertension, compared to 7.2 percent of those on a placebo.
Based on the extent of increased blood pressure caused by Savella, the FDA medical officer who reviewed the drug estimated persistent blood pressure hikes could increase the risk of a cardiovascular events by up to 50 percent, Public Citizen argued.
Really???
all my friends who I hear are doing well on savella must be making it up, right?
increasing cardiovascular events? these patients are obese already and sedentary because it hurts them to exercise. NOT getting treatment is more likely to result in cardiovascular events.
savella changed their life!
JaT
Pfizer must be giddy about the upcoming increase in sales of Lyrica.
Brandon
I recently heard that the FDA has approved several bioidentical hormones and that some of them can provide relief for fibromyalgia symptoms.
SAC
Thank-you “Really”!! My mom is a different person. She is actually losing weight and I can tell by her voice that she is experiencing a better quality of life since starting the medication.
Will Kline
This sounds like it was initiated by $$ from competitor5s out there to me. My wife has had an improved quality of life and the “risks” that they cite were already discussed with her doctor–they are uniform to the medications like this.
Clearly “Public Citizens” is a cover for some pharmaceutical company or has their own bizarre agenda!
pharmavet
Fibromyalgia is a bogus diagnosis anyway. A chiropracter friend of mine says that Pfizer has it both ways. Way under-reported is the incidence of myalgias from statins, especially Pfizer’s Lipitor. When the patients come into the office they are misdiagnosed with “fibromyalgia”, then get placed on Pfizer’s Lyrica. Pick your poison.
patrons99
Good point, Pharmavet. I’m not sure that ALL fibromyalgia is bogus, but for those patients on a statin, their Vitamin D3 level ought to be checked. Statin use is associated with both CoQ10 and D3 deficiency, probably due to their many pleiotropic effects. The incidence of myalgias on statin treatment is very high. I have not written-off neurontin or lyrica. I believe they both have therapeutic utility in some patients. They are not completely without risk, however.
Lisa Van Syckel
OMG,… I agree with Pharmavet 100%..