Darvon and Darvocet Alert!
Pain Medication May Put You At Risk for Fatal Abnormal Heart Rhythms
Darvon or Darvocet users take note: If you use those drugs for pain, you may be putting your heart -- and your health -- at risk.
The drug maker Xanodyne Pharmaceuticals Inc. has agreed to pull Darvon and Davocet from the U.S. market after a study linked those pain medications to serious -- and potentially fatal-- abnormal heart rhythms.
If you suspect your heart problems, including abnormal heart rhythms, were caused by Darvon or Darvocet, protect your legal rights. Immediately contact the drug injury lawyers of MEDLAW Legal Team. Call (877) 425-3448 today or use our online contact form.
Latest FDA Alert: Drug Maker Announces Withdrawal of Darvon, Darvocet
On November 19, 2010, the federal Food and Drug Administration (FDA) announced Xanodyne Pharmaceuticals Inc., which makes Darvon and Darvocet, had agreed to withdraw those two medications from the U.S. market. The FDA also asked manufacturers of pain medications containing propoxyphene to voluntarily remove those products as well. Propoxyphene is the active ingredient in Darvon and Darvocet.
The reason for the FDA announcement: New clinical data showed the drug put patients at risk of potentially serious or even fatal heart rhythm abnormalities. The agency concluded that the risks of the medication outweighed its benefits.
The FDA advised doctors and health care professionals to stop prescribing propoxyphene. Patients who took any form of the drug, including Darvon and Darvocet, were urged to contact their doctors as soon as possible to discuss other options for pain management.
History of Propoxyphene / Decades of Questions
First approved by the FDA in 1957, propoxophene is an opioid used to treat mild to moderate pain. Propoxyphene is sold by prescription as a stand-alone drug (Darvon) or in combination with acetaminophen (Darvocet).
The safety of the drug has been questioned for decades. Since 1978, the FDA has received two requests to remove propoxyphene from the market. Concerns about the drug's safety have heated up in recent months.
European drug regulators recommended in June 2009 that the marketing authorizations for propoxyphene be withdrawn, and a phased withdrawal is underway. In July 2009, the FDA required a new boxed warning for the product about the risk of a fatal overdose. In addition, the agency required Xanodyne to conduct a new safety study about the effects of propoxyphene on the heart.
The Drug's Dangers
Even when propoxyphene is taken at recommended doses, the medication “causes significant changes to the electrical activity of the heart,” the FDA press release stated. “These changes, which can be seen on an electrocardiogram (ECG), can increase the risk for serious abnormal heart rhythms that have been linked to serious adverse effects, including sudden death.”
Another alarming finding: the risk of adverse events – even in patients who have taken the drug for years – can quickly increase because of small health changes. For example, dehydration, a change in medications or decreased kidney function may put Darvon or Darvocet users at risk for serious, even fatal heart problems, according to the FDA news release.
“With the new study results, for the first time we now have data showing that the standard therapeutic dose of propoxyphene can be harmful to the heart,” said Gerald Dal Pan, M.D., M.H.S., director of the Office of Surveillance and Epidemiology, CDER.
Contact our Darvon / Darvocet Drug Injury Lawyers Today
If you’ve experienced any symptoms of heart trouble after taking Darvon or Darvocet, or generic drugs containing propoxyphene, IMMEDIATELY contact your health care provider. Also contact your doctor or other health care professional about changing to another medication.
Then call the MEDLAW Legal Team of Janet, Jenner & Suggs, LLC. We are nationally recognized for our work on behalf of victims of harmful prescription drugs. We believe the manufacturer of Darvon and Darvocet acted negligently and put YOUR HEALTH at risk – and needs to be held accountable.
Unlike many law firms that advertise on the Internet, we handle your case directly. We are experienced litigators who have the resources and experience to represent you.
If you suspect that you or a loved one has had heart problems linked to Darvon or Darvocet, or generic drugs containing propoxyphene, call our drug injury attorneys today. Contact us at (877) 425-3448 if you have questions or concerns, or use our online contact form.
Our in-house legal team consists of a physician-attorney, a nurse attorney and more than 30 staff members. As one of the nation’s premier pharmaceutical liability law firms, we represent consumers nationwide who have been victimized by defective medications, including Darvon, Darvocet and propoxyphene. We are prepared to handle Darvon or Darvocet and propoxyphene injury cases from all 50 states.
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