Jacksonville Darvocet Attorneys
We have all experienced pain at points in our life. In some cases, our medical condition or injury may prompt purchase of over-the-counter pain medication or a physician’s prescription for painkillers. As consumers, we trust that the medications we take, especially those that are intended to minimize pain, to be safe when taken as directed and free of any unknown side effects or contaminants. Darvon and Darvocet, the brand version of the prescription pain medication propoxyphene, was removed from the U.S. market by its manufacturer Xanodyne Pharmaceuticals Inc. at the request of the U.S. Food and Drug Administration (FDA) on November 19, 2010. The FDA also notified the generic manufacturers of propoxyphene-containing products about Xanodyne’s decision and asked that they remove their products.
Darvon and Darvocet Adverse Heart Effects
Propoxyphene is an opioid and was approved by the FDA in 1957 to treat mild to moderate pain. However, the FDA concluded that the potential risks of Darvon and Darvocet containing propoxyphene outweighed the benefits. Clinical data showed that propoxyphene increased a patient’s chances of suffering possibly severe or even fatal heart rhythm abnormalities.
Scientific evidence gathered by the FDA revealed that even when taken as directed at recommended doses, Darvon and Darvocet could damage the heart or cause deadly cardiac abnormalities. Those conducting the study of the affects of propoxyphene noted considerable changes to the electrical activity of the heart on an electrocardiogram (ECG). These changes reflected an increase in the risk of serious abnormal heart rhythms that had been connected to serious adverse effects, including sudden death. Data also surfaced revealing the risk of adverse events for any patient, even those who had been taking the drug for years, to be subject to change based on minor fluctuations in a patient’s health (i.e. a change in medications, decreased kidney function, or dehydration).
The FDA advised health care professionals to stop prescribing propoxyphene to patients and warned patients who were presently taking the medication to contact their health care professional immediately to talk about changing their pain management therapy. However, the advisory came too late for some patients who had already suffered heart damage and other serious cardiac problems.
Propoxyphene Warning Signs in the Past
Until the November 2010 removal of propoxyphene from the market, the FDA had determined that the benefits of opioid for pain aid at recommended doses outweighed the safety risks of the pharmaceutical. This was in spite of two requests to remove propoxyphene from the market reviewed by the FDA since 1978. Moreover, an advisory committee meeting was held in January 2009 by the FDA to evaluate and discuss the effectiveness and safety of propoxyphene. It was at this time that the FDA voted 14 to 12 against the continued marketing of propoxyphene products and decided that more data was needed about propoxyphene’s cardiac effects.
In July of 2009, the FDA permitted the continued marketing of propoxyphene as long as a new boxed warning was added to the medication’s label. The new warning alerted patients and health care professionals about the risk of fatal overdose. The FDA also required the makers of Darvon and Darvocet, Xanodyne, to carry out a new safety study evaluating concerns about propoxyphene effects on the heart.
The European Medicines Agency (EMEA) suggested in June 2009 that the marketing authorizations for propoxyphene be withdrawn throughout the European Union. As of November 2010, a phased withdrawl of propoxyphene was in progress.
Florida Darvon and Darvocet Injury Lawyers
At Farah and Farah, our Darvon and Darvocet injury attorneys understand the unexpected physical, emotional, and financial challenges that you and your family may be experiencing. Our firm is committed to protecting the rights of those afflicted by dangerous and defective drugs. With our legal resources and knowledge, we will gather all of the appropriate evidence to build a strong and effective case for you. To learn more about how Farah and Farah can help you hold negligent drug manufacturers liable, call us today for a free consultation.
Our personal promise: Accident victims have specific rights, but by law you have a limited time to take action. When you use our team at Farah & Farah, there are NO up-front charges.
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Our fee is a percentage of the money awarded payable only when your case is successfully concluded. No matter how many times you call and how long we talk, there is NO CHARGE or cost until your case settles. Do not sign any releases, agreements or give any statements until you have spoken with us about your legal rights. When it comes to getting you more, we won't settle for less!
We personally promise that you will be treated with the respect and dignity you deserve. We promise to keep you up to date and informed as to developments in your case. Your case is important to us, regardless of size.
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