Comments on: Vicodin, Percocet face U.S. ban http://www.epharmacies.com/online-pharmacy-medicine-blog/vicodin-percocet-face-u-s-ban/ Wed, 13 Oct 2010 20:21:38 +0000 hourly 1 http://wordpress.org/?v=3.0.1 By: Taylor Dejoseph http://www.epharmacies.com/online-pharmacy-medicine-blog/vicodin-percocet-face-u-s-ban/comment-page-1/#comment-1598 Taylor Dejoseph Mon, 14 Jun 2010 03:32:49 +0000 http://www.epharmacies.com/online-pharmacy-medicine-blog/?p=275#comment-1598 A Great write up, I will be sure to save this in my Mixx account. Have a good evening. A Great write up, I will be sure to save this in my Mixx account. Have a good evening.

]]> By: Pithius http://www.epharmacies.com/online-pharmacy-medicine-blog/vicodin-percocet-face-u-s-ban/comment-page-1/#comment-628 Pithius Wed, 15 Jul 2009 05:11:49 +0000 http://www.epharmacies.com/online-pharmacy-medicine-blog/?p=275#comment-628 The FDA Meeting Issue Background Document is at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/UCM164897.pdf Options 1(a) and 1(b) propose limitation of acetaminophen to 325mg per dose for OTC sales (and possible inclusion of all prescription formulations). Option 5(b) proposes eliminating all prescription medications complexed with acetaminophen. What is not (directly) stated by the FDA is the single most significant factor at play. Hydrocodone (Vicodin, Lortab) complexed with acetaminophen is a Schedule III medication. Hydrocodone (alone) is under Schedule II. And there currently is NO SUCH PRODUCT manufactured! Thus, the FDA [if they choose to vote for Option 5(b)] will (effectively) "re-schedule" hydrocodone from Schedule III to the *much* more restrictive Schedule II (written prescriptions only, maximum 30-day supply, etc.). Addressing the current non-existence of any hydrocodone (only) product, the FDA Background Document (lazily) states: “For development of hydrocodone single-agent formulations, implementation would include:" ... "Submission of NDAs and ANDAs for single-ingredient hydrocodone products, which may also require clinical studies for demonstration of efficacy.” A reported 460,000 prescriptions for hydrocodone with acetaminophen are written and filled every business day in the United States. (Despite) the fact that the public comment window has passed, all affected patients, physicians, and institutions would be wise to protest - loudly. The FDA Meeting Issue Background Document is at:
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/UCM164897.pdf

Options 1(a) and 1(b) propose limitation of acetaminophen to 325mg per dose for OTC sales (and possible inclusion of all prescription formulations).

Option 5(b) proposes eliminating all prescription medications complexed with acetaminophen.

What is not (directly) stated by the FDA is the single most significant factor at play. Hydrocodone (Vicodin, Lortab) complexed with acetaminophen is a Schedule III medication. Hydrocodone (alone) is under Schedule II. And there currently is NO SUCH PRODUCT manufactured!

Thus, the FDA [if they choose to vote for Option 5(b)] will (effectively) “re-schedule” hydrocodone from Schedule III to the *much* more restrictive Schedule II (written prescriptions only, maximum 30-day supply, etc.).

Addressing the current non-existence of any hydrocodone (only) product, the FDA Background Document (lazily) states:
“For development of hydrocodone single-agent formulations, implementation would include:”
… “Submission of NDAs and ANDAs for single-ingredient hydrocodone products, which may also require clinical studies for demonstration of efficacy.”

A reported 460,000 prescriptions for hydrocodone with acetaminophen are written and filled every business day in the United States. (Despite) the fact that the public comment window has passed, all affected patients, physicians, and institutions would be wise to protest – loudly.

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