Consumers expect that if they are prescribed a medication by their doctor, that the drug has been approved by the FDA and is safe for them to use without the risk of serious harm. Unfortunately, some medications are inadequately tested by the drug manufacturing company, and other pharmaceutical companies actually conceal the more serious side effects associated with their medications in order to expedite the FDA approval process. This deceptive practice puts consumers unknowingly at risk for suffering from severe, potentially life-threatening illnesses. Unfortunately, a number of dangerous drugs are on the market today and are taken by millions of consumers across the country on a daily basis.
Propoxyphene is an opioid pain-killer which was first developed in the 1950s and approved by the FDA in 1957 to treat mild to moderate pain. Since its inception, propoxyphene has been marketed under a number of brand names, including Darvon and, in combination with acetaminophen, Darvocet. Both Darvocet and Darvon are prescription analgesic medications manufactured by Xanodyne Pharmaceuticals Inc., and are commonly prescribed to individuals suffering from arthritis pain and other painful medical conditions. Darvocet and Darvon are both ingested orally and can be found as Darvocet N-50, Darvocet N-100, and Darvocet A500 tablets, and Darvon capsule-form. Narcotic analgesics like Darvocet and Darvon function by affecting how the brain senses pain.
Proof of heart side effects present in otherwise healthy people taking normal doses of Darvocet or Darvon was the determining factor in the establishment of the FDA recall. Unfortunately, the FDA ban came long after the dangers associated with Darvocet and Darvon were discovered, and, according to estimates provided by the Public Citizen group, these drugs contributed to thousands of deaths during the additional time they remained on the market. The U.S. recall was instituted five years after these drugs were banned in the U.K. and more than a year after the drugs were banned across the European Union by the European Medicines Agency.
In 1978, the consumer interest group called Public Citizen petitioned the FDA to ban the defective drugs, but the attempt was unsuccessful. Another petition was addressed to the FDA regarding Darvocet and Darvon in 2006 by Public Citizen, but the matter wasn’t put before an advisory committee until 2009. Even though this committee voted to remove the drugs from the market, the FDA overruled the decision, instead simply requiring Xanodyne to study the potential side effects of the drugs, particularly on the heart. In the meantime, the FDA allowed Xanodyne to resume manufacture of the medication, with the contingency that the company would include a black box warning on the drugs’ labels regarding the risk of fatal overdose. When the results of the additional study were released, the FDA finally recalled both Darvocet and Darvon in November of 2010.
According to the new study Xanodyne was required to perform, even consumers who take the recommended doses of Darvocet and Darvon face a significantly increased risk of developing potentially fatal medical issues. Researchers found that propoxyphene significantly altered the electrical activity of the heart, which can increase an individual’s risk of suffering from severe irregular heart rhythms, or arrhythmias. These cardiac abnormalities have been associated with major adverse side effects, including sudden death. Furthermore, consumers who have taken Darvocet or Darvon for a long period of time without experiencing serious injury or illness may be at risk for suffering from severe side effects in the future brought on by even the smallest changes in the individual’s health, including a change in additional medication or dehydration.
Besides the significant risk of developing cardiac abnormalities, Darvocet and Darvon have the potential to cause a number of other side effects, including:
Other side effects of Darvon and Darvocet use include but are not limited to headaches, a lightheaded feeling, constipation, abdominal pain, and weakness.
It is estimated that 10 million people were prescribed Darvon, Darvocet and other propoxyphene medications in 2009, and according to an FDA study, more deaths are linked to Darvocet and Darvon than to other similar pain medications. If you are currently taking Darvocet or Darvon as part of your pain relief therapy, do not terminate use of the medication without medical consent, as this may cause even more harmful withdrawal symptoms. Instead, consult your physician as soon as possible to discuss your treatment options. With the help of your doctor, you may be able to find a safer alternative to Darvon and Darvocet for treating your painful medical condition.
The side effects associated with the use of Darvocet and Darvon are extremely dangerous and potentially fatal. Many people have taken these medications in hopes that their pain will be alleviated, only to find out that the drugs have the potential to cause life-threatening illnesses, including cardiac abnormalities and sudden death. Victims of severe adverse side effects associated with the use of analgesic medications like Darvocet and Darvon are not at fault and may be entitled to reimbursement for their injuries.
If you or a loved one has suffered from cardiac abnormalities and you believe Darvocet or Darvon to be the cause, contact a Darvocet or Darvon attorney to discuss the benefits of 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 Darvocet and Darvon lawsuits and Darvon and Darvocet class action lawsuits is to seek financial compensation for your injuries, the expenses resulting from injury treatment, and the pain and suffering sustained by you and your family. If Darvocet or Darvon use has led to a fatality, the victim’s family members may have grounds to file a wrongful death lawsuit against the manufacturing company. With the help of an experienced Darvon or Darvocet lawyer, victims of potentially fatal injuries can collect the compensation they deserve.