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Additional Information from Public Citizen

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    Public Citizen urges the committee to recommend that the Food and Drug Administration (FDA) require a boxed warning and contraindication against the use of steroids for epidural injection, based on the fact that there is a class-wide risk of rare but catastrophic adverse neurologic events that cannot be eliminated through current mitigation strategies. This risk far outweighs any limited benefits of such injections.
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    In an invited commentary, Public Citizen reports that the ever-expanding outbreak of life-threatening fungal meningitis in back pain patients linked to steroid injections prepared by a compounding pharmacy, which so far has sickened at least 214 people and killed 15 in 15 states, is a public health catastrophe. What is particularly tragic for those who have been sickened or killed by the tainted drug and for their loved ones is that this situation was completely avoidable.
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    The widely publicized outbreak of life-threatening fungal meningitis in back-pain patients linked to steroid injections highlights the failure of the Food and Drug Administration’s (FDA’s) regulatory oversight of drugs prepared and sold by compounding pharmacies.

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