Tulsa World: FDA considering banning painkillers Vicodin, Percocet, Darvocet

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FDA considering banning painkillers Vicodin, Percocet, Darvocet

By SUZY COHEN Dear Pharmacist
Published: 7/11/2009 2:25 AM
Last Modified: 7/11/2009 4:58 AM

Dear Pharmacist, I am stressed out that I may not be able to get my pain medication, Vicodin. I've taken it for years, following a work accident. I'm not addicted. I really have pain but the pharmacist told me that it's going off the market. I can't live without it.
— P.T., Belleview, Fla.

We won't know the fate of these drugs for months. Currently, the FDA is considering banning narcotics like Vicodin and Percocet, two popular painkillers because they contain acetaminophen (Tylenol). They are also suggesting that limitations be set on the dosage of Tylenol in many over-the-counter medications.

Consumers don't realize that OTC drugs contain acetaminophen and unknowingly combine the painkillers with cough/cold remedies, sleep aids, and fever reducers that also contain acetaminophen. This taxes the liver and may cause nausea, vomiting, abdominal pain and yellowing of the skin or eyes. In fact, overdoses from acetaminophen are the leading cause of liver failure, which each year makes some 50,000 people sick and proves fatal to about 200. This is why the FDA is intervening.

They are suggesting that Tylenol 1000 mg be sold by prescription only, while lower dosages remain available over-the-counter. I agree this needs to happen because it protects

you

. I disagree with the ban on Vicodin or Percocet, which help people with severe pain.

The FDA has triggered panic in many people who genuinely need pain relievers for some quality of life. Drug-seekers, who exaggerate their level of pain to physicians (to get their monthly stash), are also in a tizzy. Put it this way, if Percocet and Vicodin disappear, millions of lives will become unbearable. There will be a stampede to doctors' offices to get alternative medications like morphine, Oxycontin or Dilaudid.

Not to upset you any more, but another extremely popular painkiller, Darvocet N-100 (propoxyphene/acetaminophen) is also under fire.

info@dearpharmacist.com By SUZY COHEN Dear Pharmacist

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If you see a comment that violates our terms and conditions, please help us by clicking the "Report this Comment" link next to a comment. That will alert the web staff to review the comment. Thank you. -- Web Editor Jason Collington

	Report Comment Arbythree, Tulsa (7/11/2009 12:50:56 PM) How will some of the bloggers on here survive?
	Report Comment Milo, PoDunk (7/11/2009 6:01:09 PM) How will House survive??
	Report Comment What in the World!, Tulsa, OK (7/12/2009 7:35:00 AM) Ban it, ban it, ban it! The government acts like we can not think for ourselves! Just ask Bo and the liberals who elected him!
	Report Comment tao4mind, Enid (7/13/2009 1:56:24 AM) Ultram, a centrally acting synthetic opioid analgesic.
	Report Comment Pithius, (7/14/2009 4:27:59 AM) Source: The FDA meeting issue Background Document. 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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