1. What is the decision or change you are facing or struggling with where a summary of the evidence would be helpful? 

There are ongoing serious concerns about the use of corsicosteroid drug use, drug safety, efficacy, limitations of use, practice of medicine using steroid drugs in a contraindicated manner (See Kenalog and Depomedrol Labeling), insufficient class warnings issued by FDA, and the serious neurological reactions that are occurring. There is a strong causal connection between Arachnoiditis and steroid injections, animal studies demonstrate this in addition to patients diagnosed with Arachnoiditis.

2. Why are you struggling with this issue? 

The studies on epidural steroids and Arachnoiditis go back many decades. There is strong evidence to support that epidural steroid injections should be contraindicated and Limitations of use should certainly include any epidural or intrathecal injection. The FDA has failed to protect the public from the severe dangers associated with Arachnoiditis and epidural steroid drugs. My United States Senator shared my concerns and has requested an FDA briefing to learn what programs are being currently used to decrease the use of epidural steroid drugs.

3. What do you want to see changed? How will you know that your issue is improving or has been addressed?

FDA must look at placing Epidural steroids into REMS program for optimal drug safety for people serious about preventable harm from drugs. There must be added language to the class warning and safety warning announcement. There must be education to healthcare providers, perhaps via REMS, to understand the dangers and risks associated with its drug use. There must be more review of evidence to establish that Arachnoiditis is a public Health crisis and concern. The rates of epidural steroid drugs are at a record high according to CMS and VA statistics.

4. When do you need the evidence report?

Tue, 02/25/2020

5. What will you do with the evidence report?

I will need an evidence review from EPC to review with my Senator in a meeting on February 25th.

I will immediately email any requested documents if necessary and as needed.

(Optional) About You

What is your role or perspective? Patient

If you are you making a suggestion on behalf of an organization, please state the name of the organization:

May we contact you if we have questions about your nomination? Yes