After over thirty years of consumer advocacy groups petitioning for the ban of Darvocet and Darvon, the drug manufacturer finally pulled them from the market per request of the U.S. Food and Drug Administration (FDA). Now that Darvocet, Darvon, and other generic forms of the drug propoxyphene are no longer available, patients who had been using the synthetic opioid to treat mild to moderate pain have had to turn to alternative medications to find relief.
This has left one lingering question on the minds of those who were forced to abruptly stop taking their medication: what is the real reason behind the ban? Your doctor will likely offer you the short answer about the negative side effects of Darvocet outweighing its benefits, but here is the full story for those of you who are curious about the events that led to this ban in the first place.
Since it was first introduced by Eli Lilly & Company in 1957 under the brand name Darvon, propoxyphene had been praised for its relatively high level of pain relief combined with low risk of dependency compared to other opioid pain relievers such as morphine. After the drug had received such good feedback from the public and medical professionals, Eli Lily combined propoxyphene with acetaminophen (the active ingredient in Tylenol) creating the drug Darvocet, which gained FDA approval in 1972.
Within three years, propoxyphene was prescribed approximately 120 million times, averaging just fewer than 40 million prescriptions per year. But the acclaimed miracle drug that had received so much attention from the medical community for its non-habit forming pain relieving qualities soon began to receive a much different type of attention.
Studies of the drug began to surface stating that its pain relieving properties were no stronger than those of Aspirin, as well as reports of the drug causing death in hundreds of patients. These reports led to public doubt about the true benefits of the drug, as well as consumer advocacy groups lobbying for a ban of the drug altogether.
One consumer advocacy group in particular was instrumental in getting Darvocet pulled from the market. The consumer advocacy group Public Citizen went as far as calling propoxyphene the deadliest prescription drug in the United States, referring to the drugs connection to thousands of deaths when petitioning the Department of Health, Education and Welfare to pull the drug from the market in 1978. The following year, the request was denied and propoxyphene remained on pharmacy shelves much to the chagrin of Public Citizen.
In 2006, Public Citizen recommenced its action against propoxyphene by filing a second petition with the FDA to ban Darvocet, Darvon and all other drugs containing propoxyphene. The petition was denied for the second time, however this time the group responded with a lawsuit against the FDA in 2008 over its rejection to remove a drug that was linked to over 2,000 accidental deaths that occurred between 1981 through 1999, according to Public Citizen. By doing so, Public Citizen had lifted the veil of secrecy that had kept the information of the possible dangers of propoxyphene from consumers, putting pressure on the FDA by exposing the reports of potentially life threatening Darvocet side effects to the public.
In response, the FDA deferred the case to an independent advisory committee, which voted 14-12 for the drug to be removed from the market. After the ruling however, the FDA overruled the decision, alleging that additional proof was necessary to fundamentally modify the drugs benefit/risk profile. These profiles are used to determine the overall safety of a product.
Xanodyne Pharmaceuticals, Inc., the drug manufacturer who had taken possession of the Darvon and Darvocet brands from Eli Lilly, was required by the FDA to perform additional research on the effects of propoxyphene on the heart. The research results concluded that propoxyphene caused disturbances in coronary electrical activity, and almost immediately the FDA called for all forms of propoxyphene to be removed from the United States market.
Within the first month from the time of the decision to pull the drug from the market, the first lawsuit against the drug manufacturer had already been filed, with more cropping up left and right in the months to follow. The massive amount of evidence that had been offered to the FDA on the dangerous side effects of Darvocet, Darvon and other propoxyphene products has now become ammunition for the prosecution in the ongoing litigation against the drug manufacturer.