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Carol Eustice

Darvocet to Stay on the Market With Additional Warnings

By July 7, 2009

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A decision has been made on the status of Darvocet -- a pain medication used by arthritis patients and others who live with chronic pain. The FDA has decided to allow propoxyphene-containing products like Darvon and Darvocet to stay on the market. The regulatory agency is requiring manufacturers to strengthen their label though -- including a boxed warning and a medication guide to be given to patients that will emphasize the potential for fatal overdose and the importance of using propoxyphene-containing drugs as directed.

The FDA is also requiring a safety study that will assess the effects of propoxyphene on the heart when taken at higher than recommended doses. The FDA is leaving the door open to take further action, if necessary, based on the results of that study and other data. The FDA plans to work with several groups to study how often elderly patients are prescribed propoxyphene rather than other pain medications. They will also further evaluate safety profiles of propoxyphene compared to other pain medications.

For now, the FDA has concluded the benefits of pain relief, when taken at recommended doses, outweigh the risks. The FDA also denied a petition from Public Citizen that requested a phased withdrawal of propoxyphene. The opioid drug has been marketed for over 50 years and as it stands now -- it's staying. If you depend on the drug to manage your pain and if you were concerned about the FDA's decision, this news will come as a relief. Share your comments.

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Comments
July 8, 2009 at 2:32 pm
(1) Joanne T. Sparklin says:

I have been taking darvocet-N 100 for almost 35 years for my arthritis pain. Of course I use the generic form since it came on the market but it is the only thing that gives me relief from the pain in my knees and lower back. When I was working I had to take it 2times daily(1tab every 6 hrs).Now that I’m retired I take 1 tab in the morning and it stays with me all thru the day. I have not had any side effects from using darvocet ever!!!My doctor and I have tried all the other arthritis meds out there and none help with my pain only darvocet does. PLEASE DO NOT ban it.

July 8, 2009 at 4:32 pm
(2) Jane Howell says:

I have used Darvocet N-100 for nearly 40 years as need for arthritis pain. I’m so glad it will not be removed from the market.

July 8, 2009 at 9:01 pm
(3) Wendy says:

‘Bout time those folks at the FDA got it right!!! I am a happy camper. I have fibromyalgia, and DarvocetN-100 is my first choice for pain relief. Has anyone heard what will happen to Vicodin? That is next, for when my pain is so bad I need to literally crawl out of bed to go to work.

July 9, 2009 at 6:41 am
(4) Nancy Alessio says:

Amen!!!:))) Thank you to the “powers to be” that they were able to see that benefits of Darvocet outweigh the risks and for denying Public Citizens request. I agree that people using Darvocet need to be educated and aware of the dangers of taking more than what the physician has prescribed plus taking any over-the-counter drugs that contain acetophetamine. I have been using Darvocet for over 10 years for chronic pain. It doesn’t take all the pain away-it just makes it tolerable so that I might continue to function in a productive way on a daily basis-which doesn’t happen frequently. So what is the next drug of choice for Public Citizen attempting to get rid of for the “good” of mankind!?

June 14, 2012 at 6:43 am
(5) Ronnie says:

I thought this drug was phased out before 2009. All I know is that I have chronic pain with DJD, sciatica, osteoarthritis, leading into Rheumatoid Arthritis. I also have pain in my neck from being rear-ended in a car and I’m in constant pain. I also have Fibromyalgia. They need to put this drug back on the market cuzz it’s the only thing that works for me and many others that have taken it for years. I took it for only about a year myself and I’m not addicted to it. I’ve tried other drugs like Ultram and they take my breath away cuzz I have asthma and apnea. I believe that peple have either taken too much of it or kids or movie stars have overdosed on it and they’ve totally reuined it for the people that really need it. The kidz need to stay out of our pills. They’ve found plenty of other things to get high on: paint, liquid air, etc: So these kids or the ones that are abusing it or taking it in combination with other drugs need to get a life and let us have our lives without pain.

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