Darvocet (Propoxyphene)
Darvocet (Propoxyphene), also known as “the worst drug in history” was first approved by the US Food and Drug Administration in 1957. Invented by Eli Lilly & Co., Darvon and Darvocet, the medication was sold to Xanodyne Pharmaceuticals, which marketed the drug under the brand names Darvon and Darvocet. The main component of Darvocet is propoxyphene. Propoxyphene is a type of narcotic pain reliever. This medication is similar to codeine and was used to treat mild to moderate pain. When propoxyphene was mixed with acetaminophen, it was sold as Darvocet, and was one of the top 25 most-prescribed drugs in United States , and was withdrawn from shelves in 201-. (Sink. 2011) This drug was banned in the United States in 2010, due to cardiac affects on patients taking it.
FDA Guidelines According to FDA.gov 2009, the definition of recalls is, an action taken …show more content…
(Gandey, 2011) The consumer group Public Citizen first suggested removal of propoxyphene from the marketplace due, in 1978 to its addictive properties and how easy it was to overdose with this prodiuct. A vote was comducted and it was voted 14-12 to remove the drug from the shelves but FDA regulators overruled this decision, and instead Xandyne was required to add a warning label on the Darvocet box. The FDA also asked Xanodyne to conduct a complete and in-depth study of Propoxyphene. The conclusion of the study showed a clear cardiac toxicity prompting the FDA to withdraw of all propoxyphene-based drugs from the market.(Sink, 2011) At the time of recall it was estimated that 10 million Americans are taking Darvocet and other propoxyphene painkillers. (DeNoon, 2010) Consumers were warned to not stop the medication abruptly because of the intense withdrawal
Darvocet (Propoxyphene), also known as “the worst drug in history” was first approved by the US Food and Drug Administration in 1957. Invented by Eli Lilly & Co., Darvon and Darvocet, the medication was sold to Xanodyne Pharmaceuticals, which marketed the drug under the brand names Darvon and Darvocet. The main component of Darvocet is propoxyphene. Propoxyphene is a type of narcotic pain reliever. This medication is similar to codeine and was used to treat mild to moderate pain. When propoxyphene was mixed with acetaminophen, it was sold as Darvocet, and was one of the top 25 most-prescribed drugs in United States , and was withdrawn from shelves in 201-. (Sink. 2011) This drug was banned in the United States in 2010, due to cardiac affects on patients taking it.
FDA Guidelines According to FDA.gov 2009, the definition of recalls is, an action taken …show more content…
(Gandey, 2011) The consumer group Public Citizen first suggested removal of propoxyphene from the marketplace due, in 1978 to its addictive properties and how easy it was to overdose with this prodiuct. A vote was comducted and it was voted 14-12 to remove the drug from the shelves but FDA regulators overruled this decision, and instead Xandyne was required to add a warning label on the Darvocet box. The FDA also asked Xanodyne to conduct a complete and in-depth study of Propoxyphene. The conclusion of the study showed a clear cardiac toxicity prompting the FDA to withdraw of all propoxyphene-based drugs from the market.(Sink, 2011) At the time of recall it was estimated that 10 million Americans are taking Darvocet and other propoxyphene painkillers. (DeNoon, 2010) Consumers were warned to not stop the medication abruptly because of the intense withdrawal