Boston, MAConsumers worried about the potentially lethal side effects of the diabetes drug Avandia have begun calling for sweeping changes to the US Food and Drug Administration's (FDA's) approval process, according to a recent report in the Boston Globe.
The problem, according to one critic of the system, is that the FDA lacks the checks and balances necessary for a more thorough approval process, leading many side effects to slip by unnoticed. The article cites the FDA's failure to heed the warnings of many of its staffers on Merck's recently pulled painkiller Vioxx and GlaxoSmithKline's Avandia, which were both found to possess potentially fatal side effects.
Avandia reduces the insulin resistance in the body to help use what little supply it already has as a means of combating the debilitating effects of diabetes. This process makes users more susceptible to a number of harmful conditions, including hypersensitivity, cardiac failure, hepatic impairment, macular oedema and bone fracture, as well as less serious risks like weight gain and fluid retention.
Iowa Senator Charles Grassley and Montana's Max Baucus have led the charge to empower the FDA's surveillance office to pull potentially dangerous drugs like Avandia and have introduced pending legislation that could help the organization respond more quickly to the discovery of dangerous side effects.
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