The prominent consumer group Public Citizen has petitioned the FDA to initiate a recall for Savella, saying that the fibromyalgia drug’s heart and suicide risks outweigh its benefits.
The Savella recall petition was sent to the agency on January 20, calling for the drug’s immediate removal from the market. Public Citizen claims that the benefits of the drug are highly questionable, and note that side effects of Savella could increase the risk of hypertension, heart problems and has been linked to suicidal tendencies.
Savella (milnacipran) is produced by Cypress Bioscience, Inc. and Forest Laboratories, Inc. It is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) and is similar to many antidepressants currently on the market. The drug is contraindicated for people taking monoamine oxidase inhibitors (MAOIs) and those who have uncontrolled narrow-angle glaucoma.
It was approved by the FDA for treatment of fibromyalgia in adults on January 14, 2009. While the drug is used as an antidepressant in Europe, the European Medicines Agency (EMEA) refused to approve Savella for fibromyalgia treatment in July 2009, saying that the drug had marginal benefits that failed to outweigh the health risks from Savella side effects.
Fibromyalgia, or fibromyalgia syndrome, is a condition that manifests as widespread chronic pain and is estimated to affect between 2-4% of the population. However, much of the medical community disputes how to diagnose the syndrome, and many do not believe it is an actual disease because of a lack of objective diagnostic tests and physical abnormalities on examination. While some say it may be a neurological condition, possibly brought on by stress and resulting in oversensitive pain receptors, others say it may be a “non-disease.”
According to Public Citizen, two randomized clinical trials with Savella found that the drug increased blood pressure, heart rate and suicidal thoughts. Nearly 20 percent of the trial’s participants who were given Savella developed hypertension, compared to 7.2 percent who were given a placebo. Public Citizen said that FDA’s own reviewers determined that Savella could increase the risk of heart problems, such as strokes, heart attacks and sudden death, by as much as 50 percent.
The group claims that studies have shown Savella increases the risk of seizures, addiction, excessive bleeding, mood disorders, fractures, glaucoma, nausea and vomiting. They also indicate that the drug can put fetuses, newborns and nursing infants at risk when used by pregnant mothers, and can cause reproductive problems in men.
In addition, Public Citizen says that there is evidence that the drug does not work. Public Citizen claims the director of FDA’s Division of Anesthesia, Analgesia and Rheumatology Products has said that Savella did not relieve pain, the main symptom of fibromyalgia, in clinical trials.
“Fibromyalgia is a chronic disease, but neither of the drug’s trials showed any statistical effectiveness beyond three months,” Public Citizen said in a press release. “And even within the trials’ three-month duration, more than 90 percent of users in the trial received no benefit from the drug at all.”