What Is Darvocet / Darvon (propoxyphene)?
Darvocet / Darvon (Propoxyphene) is a narcotic pain reliever. Generic Darvocet is an analgesic drug. Structurally, it’s a related to the synthetic narcotic – Methadone.
Darvocet Side Effects
The opioid painkiller propoxyphene has been widely used in the United States since it gained FDA approval in 1957 under the brand name Darvon. Eli Lilly & Company, the drug’s maker at the time, capitalized on the gap that then existed between relatively weak painkillers such as Aspirin and potent, highly-addictive narcotics like morphine. Darvon was thus hailed as a breakthrough in pain management and, building on its success, Eli Lilly and company formulated Darvocet (propoxyphene in combination with acetaminophen), which gained FDA approval in 1972.
In the three years following Darvocet’s introduction, propoxyphene remained very popular, But new studies that concluded propoxyphene was no more useful as a painkiller than two aspirin and reports linking the drug to the death of 589 Americans led many to begin questioning its overall benefits.
Public Citizen renewed its attack on propoxyphene with a second petition, this time filed with the FDA, to ban propoxyphene products in 2006. The group’s effort was rebuffed once again, but this time it responded to defeat by suing the FDA in 2008 because its refusal to remove from the market a substance that, according to Public Citizen, was linked to 2110 accidental deaths between 1981 and 1999.
The lawsuit put pressure on the FDA, which deferred the fate of propoxyphene to an independent advisory committee. The panel voted 14-12 for the drug’s market withdrawal, but the FDA overruled its decision, stating that further evidence was needed, particularly concerning propoxyphene’s effects on the heart, to fundamentally alter its benefit/risk profile (which the agency uses to determine the overall safety of a product).
The FDA required Xanodyne Pharmaceuticals, Inc., which in recent years had taken possession of the Darvon and Darvocet brands from Eli Lilly & Company, to conduct research into the effects of propoxyphene on the heart. The results, which showed that the drug causes disturbances in coronary electrical activity even at prescribed doses in healthy patients, sealed the substance’s fate, as the FDA soon after requested that all forms of propoxyphene be removed from the U.S. market.
It took less than three weeks from the time of the FDA’s decision for the first lawsuit to be filed against Xanodyne and in the coming weeks and months, many more propoxyphene lawsuits are expected. The evidence presented over the years to the FDA pointing to the drug’s potential to cause heart problems and accidental overdose death will likely now be used as proof that drug manufacturers should have reasonably known about, but failed to provide sufficient warning of, the pain reliever’s hazards.
The serious and sometimes fatal side effects of Darvocet, Darvon, and propoxyphene prompted the FDA to recommend a ban on the popular pain medications stating their conclusion that “the pain relief benefit no longer outweighed the health risks.”
The side effects of Darvocet include:
- Heart arrhythmia
- Heart electrical changes
- Heart attack
- Accidental Death
Darvocet has long been associated with addictive qualities, dangerous drug interaction, and overdose. Prior to issuing the ban, the FDA had previously required a black box warning to appear on drugs containing propoxyphene so that those taking it would be aware of such risks including drug-related death. A recent study confirmed that propoxyphene can interfere with the electrical activity of an otherwise healthy heart, causing irregular heartbeat or arrhythmia and other cardiac episodes severe enough to cause death. Experts estimate that thousands have died from such side effects of Darvocet.
Symptoms associated with using Darvocet:
- upset stomach
- stomach pain
- difficulty urinating
- difficulty breathing
- mood changes
Those who are currently using Darvocet are encouraged to consult with their doctors about other forms of pain management.