Recent research has led to a ban on two prescription pain medications, Darvocet and Darvon. According to the FDA, the possible pain relieving benefits of these drugs are significantly outweighed by the potential for the medications to cause severe adverse side effects in consumers, including potentially fatal heart rhythm abnormalities. Darvon and Darvocet are two brand name forms of the analgesic medication propoxyphene, which was approved by the FDA in 1957 to treat mild to moderate pain. Both Darvocet and Darvon are manufactured by Xanodyne and have been prescribed to individuals suffering from arthritis and other painful medical conditions.
In order for the body to receive the blood and nutrients it requires in order to function properly, the heart must beat regularly, moving the blood throughout the body. Each heartbeat is regulated by the electrical impulses which travel through the heart, and when these impulses are interrupted, a heart rhythm abnormality may occur. These abnormalities, also called heart arrhythmias, may cause an inadequate amount of blood to reach the body’s vital organs. If the heart continues to pump inefficiently, it may no longer be able to maintain adequate blood pressure, potentially resulting in fainting and even death.
The symptoms associated with a heart arrhythmia include heart palpitations, sensation of the heart racing, and a fluttering in the chest, as well as fatigue, chest pain, shortness of breath, and a light-headed feeling. Because the heart is one of the most critical organs in the body, responsible for supplying the rest of the body with essential blood and oxygen, any abnormality in the function of the heart can have serious consequences.
Although Darvocet and Darvon weren’t banned by the FDA until November 2010, the dangers associated with these medications have been evident for several years. Concern about the harmful nature of Darvon and Darvocet was first raised by a consumer interest group called Public Citizen in 1978 when they filed a petition with the FDA to remove the drugs from the market. The petition was unsuccessful and the group tried again in 2006, which led to the matter being put before an advisory committee in 2009. Based on the data available at the time, the committee ruled to ban the drugs, a decision which was quickly reversed by the FDA. Instead, the FDA simply required Xanodyne to include a black box warning on the Darvocet and Darvon labels, but allowed continued marketing while Xanodyne conducted further tests regarding the potential heart-related side effects of the medications.
As a result of these additional tests, which determined that propoxyphene use interferes with the electrical activity of the heart, the FDA established a nation-wide ban on the drugs in 2010. This study revealed that even consumers who are otherwise healthy, and who are taking the recommended doses of the medications, may suffer from life-threatening cardiac issues resulting from Darvocet or Darvon use. By altering the heart’s electrical activity, Darvocet and Darvon can increase an individual’s risk of suffering from irregular heart rhythms, or arrhythmias, which have been associated with major adverse side effects, including sudden death.
Propoxyphene-containing drugs were banned in the U.K. in 2005 and the European Medicines Agency banned use of these medications across the European Union in June 2009. Unfortunately, the FDA’s recall of these medications in the U.S. came long after these decisions. It is estimated that 10 million Americans were prescribed Darvon, Darvocet and other propoxyphene medications in 2009, consumers that would have been protected from harm had the FDA ban on the drugs been instituted when the dangerous side effects of the medications were first established.
The cardiac abnormalities associated with the use of Darvon and Darvocet have been linked with severe medical problems, including the risk of death. Victims of serious injury associated with the use of a defective drug are not at fault. Drug manufacturing companies are responsible for the safety of their medications and should be held accountable for any adverse side effects sustained by consumers of their products. Unfortunately, some pharmaceutical companies are already aware of the harmful nature of their medications but intentionally withhold this information from the public in order to prevent a recall or other negative consequences.
If you or a loved one has suffered from a heart rhythm abnormality and you believe Darvon or Darvocet to be the cause, contact a Darvocet or Darvon attorney today to discuss your legal options. You may be entitled to reimbursement for your injuries, which you can collect by filing a Darvon or Darvocet lawsuit. A number of defective drug lawsuits and class action lawsuits have already been filed against Xanodyne by individuals who suffered serious injury after taking the drugs. The goal of Darvon or Darvocet lawsuits is to seek financial compensation for your injuries, the medical expenses associated with treating your injuries, and the pain and suffering sustained by you and your family. Defective drug lawsuits also bring public attention to the importance of safe drugs and the need for more stringent restrictions on harmful drugs already on the market. If use of Darvon or Darvocet has resulted in the death of a family member, the victim’s family may have grounds to file a wrongful death lawsuit against Xanodyne, the drugs’ manufacturing company. With the help of a qualified Darvon or Darvocet lawyer, victims of serious injury caused by the use of Darvon or Darvocet can collect the compensation they deserve.