"FDA Adds Stronger Warnings to Propoxyphene"

[Heiferly]

"July 7, 2009 — The US Food and Drug Administration (FDA) is adding stronger warnings to pain medications that contain propoxyphene, such as Darvon and Darvocet, because of new data on fatal overdoses linked to propoxyphene products. The FDA is requiring the manufacturers of these drugs to strengthen the drug's boxed warning and to create a medication guide for patients."

                                                                              -from  http://www.medscape.com/viewarticle/705441


see also:

FDA NEWS RELEASE:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm170769.htm
FDA Propoxyphene Q&A:  http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm170268.htm

[OtisDaMan]

I have used propoxyphene in the form of dextropropoxyphene napsylate for thoracic pain relief for several years; indeed, in the first few years of chronic pain it was the only opioid I had tried other than codeine in the form of panadeine. When marketed as a monodrug it is usually as a 100mg capsule of DPPP-N known as doloxene; the more commonly prescribed version is a polydrug capsule containing 37.5mg of the salt dextropropoxyphene chloride and 500mg of acetominophen (aka paracetomol), marketed as capadex among other names mentioned in the FDA news. The napsylate salt form is typically more slowly absorbed (ADME) than the chloride salt form; the equivalent doses are generally taken to be 65mg of DPPP-C compared to 100mg DPPP-N.

After being told that doloxene (the monodrug form of DPPP) was really addictive by several doctors, I have to say that I did not find that to be the case for me. The key I reckon is that while the packet specs said no more than 6 capsules per day, I stuck to between 2 and 4 a day, based on how badly I was travelling pain-wise. For me this medication is far more effective than codeine - one of the mysteries of life, as dextropropoxyphene is generally ranked as being two thirds as strong as codeine. I quit only because another medication I started on - for another reason than pain - basically blocked doloxene, rendering it useless. It didn't seem particularly difficult to quit - I did it cold-turkey without incident.

While I would accept that the medication has the potential to be dangerous, I am reasonably skeptical about  an adult fatal overdosing happening upon consuming say 4-6 capsules of doloxene in a day, even as a single dose, unless there are other health issues with the "overdosee". I am aware in detail of two cases in Australia, where the "overdosees" ended up in court on drug offences relating to their procurement of doloxene. One of the overdoses involved the consumption of between 45-50 capsules of doloxene 100mg capsules, in less than 24 hours, by a male adult. He survived without medical intervention - it is worth commenting that there was a corroborating witness concerning the size of the overdose, as well as pharmacy store evidence. Stupidity knows no bounds.

The big problem is when chronic pain patients are (long-term) prescribed the polydrug form which contains 500mg acetominophen per capsule. Acetominophen *IS* possible to fatally overdose on, even at just a few capsules above the maximum recommended daily doses of 4gm for a single day (ie no use prior to or after the day in question) and of 2-3gm per day for several days at a time. Adults have been known to fatally overdose on 5gm for a single day, which corresponds to 10 capsules of acetominophen - this is extremely rare though; it usually takes closer to 10gm to be fatal. Acetominophen overdose is *the* largest category of prescribed drug fatality. Why it isn't more tightly regulated is beyond me.

My point is that while any opioid has the potential to be fatal in doses higher than the recommended daily maximum, the risk of fatal propoxyphene overdose is low compared to what is probably the most common over-the-counter painkiller, acetominophen. Keep the risks in proportion.

Regards all,

OtisDaMan

[Tuckamore]

Thank you for the information. I agree with Sandee. This drug is normally not as effective as hydrocodone or oxycodone or similar narcotics therefore ppl with pain tend to take more to ease it. Increasing the recommended dose of any medication can have serious complications.

Again thanks for the article.

[sandee1818]

I appreciate the information as I am sure everyone here does:)
I know that with these kinds of medications people will assume one is not working and take two or three and this is dangerous. They do not realize this a strong pain medication even though it is not schuduled as high as others in this class. The stronger ones such as hydrocodone are schuduled more wisley than these in my opinion. Having them seem less effective therefore some may think they can take more of it to control their pain.
Thanks for the articles:)