Why did it take so long for the Food and Drug Administration (FDA) to pull Darvocet from the market? Especially when, on several occasions, FDA advisory committees recommended to the FDA that propoxyphene-containing drugs, like Darvocet or Darvon, should be removed from the market because of safety and dependency concerns?
“It perplexed a number of us for many years that individuals were prescribed propoxyphene-containing products when these drugs didn’t appear to provide any greater pain relief than more simple approaches,” says Dr. Charles Argoff, Professor of Neurology at Albany Medical College and Director of the Comprehensive Pain Center at Albany Medical Center in Albany, New York.
Propoxyphene-containing drugs, such as Darvocet and Darvon, were finally banned from the market after new data showed the drugs were linked to an increased risk of deadly heart rhythm abnormalities.
“However, lurking out there, so to speak, is another issue,” Dr. Argoff continues. “Several years ago, Europe’s equivalent of the Drug Enforcement Agency, the Europen Medicines Agency (EMEA), received information from Norway about the use of Soma (carisoprodol) as a muscle relaxant and concerns about its ability to create dependency. In fact, Sweden and Norway have removed Soma from their markets, and the EMEA has advised all its member nations to actually remove the drug from their markets.”
Soma is still widely available in the U.S. as a muscle relaxant. Yet, Dr. Argof sys, it has its own set of issues that one should be concerned about.
“So I caution those of you who use Soma for your patients as a muscle relaxant,” he says. “I also caution you that, like Darvon and Darvocet, which for many years have been off the market in at least one other country, Soma has been taken off the market in countries outside the United States. When we prescribe, it’s important to think about what we can prescribe that will help our patients, but in the safest manner possible.”