Darvocet,Side,Effects,and,Risk law Darvocet Side Effects and Risks

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Now that Darvocet,Darvon, and other generic forms of the drug propoxyphene are no longeravailable, patients who had been using the synthetic opioid to treat mild tomoderate pain have had to turn to alternative medications to find relief. This hasleft one lingering question on the minds of those who were forced to abruptlystop taking their medication: what is the real reason behind the ban? Yourdoctor will likely offer you the short answer about the negative side effectsof Darvocet outweighing its benefits, but here is the full story for those ofyou who are curious about the events that led to this ban in the first place.Since it wasfirst introduced by Eli Lilly & Company in 1957 under the brand nameDarvon, propoxyphene had been praised for its relatively high level of painrelief combined with low risk of dependency compared to other opioid painrelievers such as morphine. After the drug had received such good feedback fromthe public and medical professionals, Eli Lily combined propoxyphene withacetaminophen (the active ingredient in Tylenol) creating the drug Darvocet,which gained FDA approval in 1972. Within threeyears, propoxyphene was prescribed approximately 120 million times, averagingjust fewer than 40 million prescriptions per year. But the acclaimed miracledrug that had received so much attention from the medical community for itsnon-habit forming pain relieving qualities soon began to receive a muchdifferent type of attention. Studies ofthe drug began to surface stating that it’s pain relieving properties were nostronger than those of Aspirin, as well as reports of the drug causing death inhundreds of patients. These reports led to public doubt about the true benefitsof the drug, as well as consumer advocacy group’s lobbying for a ban of thedrug altogether.One consumeradvocacy group in particular was instrumental in getting Darvocet pulled fromthe market. The consumer advocacy group Public Citizen went as far as callingpropoxyphene “the deadliest prescription drug in the United States,” referringto the drug’s connection to thousands of deaths when petitioning the Departmentof Health, Education and Welfare to pull the drug from the market in 1978. Thefollowing year, the request was denied and propoxyphene remained on pharmacyshelves much to the chagrin of Public Citizen. In 2006,Public Citizen recommenced its action against propoxyphene by filing a secondpetition with the FDA to ban Darvocet, Darvon and all other drugs containingpropoxyphene. The petition was denied for the second time, however this timethe group responded with a lawsuit against the FDA in 2008 over its rejectionto remove a drug that was linked to over 2,000 accidental deaths that occurredbetween 1981 through 1999, according to Public Citizen. By doing so, PublicCitizen had lifted the veil of secrecy that had kept the information of thepossible dangers of propoxyphene from consumers, putting pressure on the FDA byexposing 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 voted14-12 for the drug to be removed from the market. After the ruling however, theFDA overruled the decision, alleging that additional proof was necessary tofundamentally modify the drug’s benefit/risk profile. These profiles are usedto determine the overall safety of a product.XanodynePharmaceuticals, Inc., the drug manufacturer who had taken possession of theDarvon and Darvocet brands from Eli Lilly, was required by the FDA to performadditional research on the effects of propoxyphene on the heart. The researchresults concluded that propoxyphene caused disturbances in coronary electricalactivity, and almost immediately the FDA called for all forms of propoxypheneto be removed from the United States market. Within thefirst month from the time of the decision to pull the drug from the market, thefirst lawsuit against the drug manufacturer had already been filed, with morecropping up left and right in the months to follow. The massive amount ofevidence that had been offered to the FDA on the dangerous side effects ofDarvocet, Darvon and other propoxyphene products has now become ammunition forthe prosecution in the ongoing litigation against the drug manufacturer. The shortanswer that has been offered to most people that had been given Darvocet oranother propoxyphene product by their prescribing doctors is that the harmfulDarvocet side effects led to the ban, and switching to a safer alternative is aquick fix. If you havetaken Darvocet, however, and experienced negative side effects, you may beentitled to monetary compensation from the drug manufacturer. Law firms thatoffer well versed Darvocet side effects lawyers are available if you believeyou’ve experienced side effects after taking the drug.