Group urges recall of drug for fibromyalgia
Matthew Perrone reports, “A consumer advocacy group is asking government regulators to recall a drug they approved last year for a little-understood pain ailment, saying the pill can lead to dangerously high blood pressure” (AP for FindLaw, 1/20). The drug in question is Savella, which has been on the market for nearly a year after it was cleared by the FDA.
As a products liability lawyer with experience regarding medical drugs gone wrong, I join the consumer advocacy group in urging a recall of potentially dangerous drugs. If nothing else, more testing or the drug is certainly necessary. Interestingly, European regulators rejected Savella last summer due to “lack of effectiveness and side effects.” Many are wondering if the FDA should have reached the same conclusion.
Fibromyalgia is a disease that is “characterized by a wide range of pain-related symptoms, including muscle soreness, headache, fatigue and depression.” Recent studies of the drug have shown approximately 20 percent of patients on Savella experienced hypertension or high blood pressure, compared to 7 percent of those patients taking the placebo. Moreover, only 9 percent of study patients taking Savella experienced reduced pain, compared to 7 percent of patients taking the placebo. Clearly, there are some unanswered questions regarding this drug, which should at least prompt the FDA to reevaluate.
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