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     I have done a lot of research for this one.  So bear with me.  The FDA, the same government agency not bothering to keep us safe by watching what goes into our food until it’s too late, is now wasting time on hearings to take Darvon containing drugs off of the market, the main one being Darvocet.  I have read the 371 page agenda on the hearing, and find it hard to believe that the data is considered credible enough for this to go through.  The drug has been on the market for 50 years.  It is considered a mild to moderate pain killer.  Darvocet is a combination of Darvon, an Opioid drug and Tylenol.   Many of you may or not know that taking too much Tylenol can shut down your liver and lead to death.  The group trying to have Darvon removed as a drug choice of the American People is called Public Citizen, and this is not the first time they have tried to get Darvon removed as an option for the American people.

     Public Citizen points out that Darvon when used incorrectly can cause toxic consequences (so can Tylenol by itself) also the incorrectly part sticks out, as any medication can be taken incorrectly and cause complications.  They state that because it is a very mild pain killer, they feel it has no more benefit then Ibuprofen, they tested this on cancer patients, and most cancer patients need more than a mild painkiller to begin with.  So of course not much difference was reported.  They state that because the drug is so mild, more people will take more than prescribed leading to toxic consequences or overdose.  To me, my physician should discover how much pain I’m in, and reassess if the medication I’m being given is adequate if not, then it would be up to the Doctor if that medicine is not working  to give me a stronger pain medicine, or find other ways of pain management.  They cited that Darvocet is not a necessary drug because it was found that Lortab worked better, well of course it does, it is a moderate to severe pain medicine, a step above Darvocet.  They cited that people use Darvocet to commit suicide, really are they serious?  If someone wants to commit suicide, they are going to do it with whatever drug is available.  So, say we outlaw Darvocet; a person goes into the doctor with pain, now the doctor has to prescribe Lortab or something stronger, remember Darvocet is no longer available, and then the person overdoses on Lortab instead.  Did we fix the problem?  I think not.  They also cite that people have drug interactions with Darvocet, do they really believe drug interactions won’t occur with another drug just as easy.  Besides shouldn’t our doctor or pharmacist know what drugs were on and look to prevent drug interactions.  They also point out that people may drink alcohol while taking Darvocet and have a toxicity issue, should a person drink with any medication?  Isn’t that what the warnings on the bottle are for?  They also suggested that giving Darvocet to the elderly may cause dizziness, which could lead to falling and hip fractures.  Wow, seriously, maybe it should be outlawed for the elderly to own a cat; they may trip and sustain a hip fracture.  Also cited as one of the main reasons Darvocet should be banned was that there is a risk for dependency.  We are talking about a pain medication right?  How many narcotic pain medications is there that aren’t capable of causing addiction?  And are they really thinking that putting someone on a stronger narcotic that dependency won’t occur?

     The following is the conclusions are from the Deborah Trunzo, Office of Applied Studies,

Substance Abuse and Mental Health Services Administration, December, 2008

     Conclusions

  The number of treatment admissions for abuse of opioid analgesics has risen sharply

since 1997, following the introduction of Oxycontin.

  ?In States identifying specific pain relievers, the increase in these admissions can be

attributed almost entirely to oxycodone.

   The data suggest that propoxyphene (aka Darvocet) accounts for a very small fraction of pain reliever

admissions.

   ?The youngest opioid analgesic admissions are the most likely to inhale on inject the drug.

   ?First use of opioid analgesics by persons admitted to treatment for abuse of these drugs is

more likely to occur before the age of 25 than after the age of 25.

References

Substance Abuse and Mental Health Services Administration, Office of Applied Studies,

Treatment Episode Data Set (teds): 1996-2006. National Admissions to Substance Abuse

Treatment Services, DASIS Series: S-43, DHHS Publication No. (SMA) 08-4347, Rockville,

MD, 2008.

     This is a portion of the article stating the FDA advisory panel recommended 14-12 (a small margin) to withdraw Darvon containing medications from the market.

FDA panel recommends ban on the painkiller Darvon

Fri Jan 30, 6:09 pm ET

WASHINGTON – Government medical advisers Friday recommended a ban on Darvon, a prescription medicine that's been used to treat pain for more than 50 years but left a trail of problems such as addiction and suicide.

A Food and Drug Administration advisory panel voted 14-12 to recommend withdrawing Darvon after a daylong hearing examining its risks and benefits. The FDA is not required to follow the recommendations of its advisers, but often does so.

Darvon was first approved in 1957, when there were few alternatives for treating pain except aspirin and powerful narcotics. Now mainly marketed as Darvocet, which includes a dose of acetaminophen, the drug remains one of the top 25 most commonly prescribed medications. More than 20 million prescriptions were written in 2007.

The consumer group Public Citizen had petitioned the FDA to withdraw Darvon because the drug offers relatively weak pain relief and poses an overdose risk, with the potential to be used in suicides.

"With a drug that has almost no evidence of benefit, any risk is unacceptable," said Dr. Sidney Wolfe, a drug safety expert with Public Citizen who first sought a ban in the 1970s. "Hopefully the FDA will follow the vote of its advisers."

     I’m sure you’re wondering and rightfully so, why do I care.  I’m sure there will be many people addicted to Darvocet upset that this drug is being removed.  I do take Darvocet.  I am allergic to Codiene and Morphine and their derivatives, Darvocet is the only medication I can take, unless I move up to Fentanyl an Opioid drug that used to be used to sedate people for surgery.  I have Lupus and a ruptured disk L 4-5 that cause me pain, I take Darvocet probably a couple of times a month.  I counted what I have I filled my bottle of Darvocet 120 pills on 8-29-08 my instructions say I can take up to 4 pills daily, so this is a month supply, I currently have 80 pills left, so I took on average 8 pills a month since August.  This bottle happened to be filled after I broke my arm, so I took a little more at that time than I usually do.  It works for me, I’m not a cancer patient.  In my opinion it is definitely stronger than Ibuprofen, I do take ibuprofen for mild pain or inflammation.  I don’t want to have to take a much stronger pain medication if I don’t need it.  I completely understand the FDA taking medications off the market when they are found to cause public safety issues, like Vioxx, which I did take for several years, it caused many heart problems and we should be protected from medications causing such serious directly related health problems, but to take a drug that when used correctly off of the market, because of something someone might do with it, is ridiculous and a waste of resources for an agency that obviously can’t keep up with basic safety measures.

     In case you would like to do your own research on this, here are the links to the entire article on FDA ban on Darvon <font color="#800080">http://news.yahoo.com/s/ap/20090130/ap_on_he_me/darvon</font> and if you would like to read both sides of the argument from the FDA docket <font color="#800080">http://www.fda.gov/ohrms/dockets/ac/09/briefing/2009-4411b1-01-FDA.pdf</font> .  What pain meds are next, do we really want our physicians to have less choices in managing our health?

 

    

 

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• Darvocet
• FDA
• Ban