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DiscussionShingrix and peripheral neuropathy
Neuropathy | Last Active: Nov 3 12:52pm | Replies (538)Comment receiving replies
Replies to "Here is my current update of my SFN. Yesterday was my first morning after taking 300mg..."
@dont Hi, Just wanted you to be aware that 900 mg. of Gabapentin daily is still not the maximum daily dose of Gabapentin. If the stuff is helping you, and your feel like you need even more than 900 mg., talk to your Doc. I am not at all familiar with the RST SANEXES, but best of luck!!! Lori Renee
@dont, prompted by @jeffrapp's post questioning the FDA status of Sanexas, I looked into it too. Management of neuropathy symptoms is limited, thus patients turn to alternative treatment in the hope of relief. When considering complementary or alternative treatments, be open-minded yet skeptical.
RST Sanexes is FDA Cleared, but not Approved according to the company's website. This distinction is important.
"1. Clearance: When a medical device is cleared, this means it has undergone a 510(k) submission, which FDA has reviewed and provided clearance.
2. Approval: For Class III medical devices to be legally marketed they must undergo a rigorous review and approval process. Following a successful submission of a premarket approval (PMA) or a Humanitarian Device Exemption (HDE), the device is given Approval by FDA.
3. Granted: Medical devices using the De Novo pathway must be Granted by FDA before they can be legally marketed in the United States. This is a relatively new term in the FDA lexicon."
You can read more here:
- How FDA Distinguishes Between Clearance vs. Approval vs. Granted https://www.greenlight.guru/blog/fda-clearance-approval-granted