FDA Alerts

FDA NEWS RELEASE

For Immediate Release: Nov. 19, 2010
Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
Xanodyne agrees to withdraw propoxyphene from the U.S. market

Xanodyne Pharmaceuticals Inc. which makes Darvon and Darvocet, the brand version of the prescription pain medication propoxyphene, has agreed to withdraw the medication from the U.S. market at the request of the U.S. Food and Drug Administration. The FDA has also informed the generic manufacturers of propoxyphene-containing products of Xanodyne’s decision and requested that they voluntarily remove their products as well.

The FDA sought market withdrawal of propoxyphene after receiving new clinical data showing that the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities. As a result of these data, combined with other information, including new epidemiological data, the agency concluded that the risks of the medication outweigh the benefits.  

“The FDA is pleased by Xanodyne’s decision to voluntarily remove its products from the U.S. market,” said John Jenkins, M.D., director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research (CDER). “These new heart data significantly alter propoxyphene’s risk-benefit profile. The drug’s effectiveness in reducing pain is no longer enough to outweigh the drug’s serious potential heart risks.”
The FDA is advising health care professionals to stop prescribing propoxyphene to their patients, and patients who are currently taking the drug should contact their health care professional as soon as possible to discuss switching to another pain management therapy.

Propoxyphene is an opioid used to treat mild to moderate pain. First approved by the FDA in 1957, propoxophene is sold by prescription under various names both alone (e.g., Darvon) or in combination with acetaminophen (e.g., Darvocet).

Since 1978, the FDA has received two requests to remove propoxyphene from the market. Until now, the FDA had concluded that the benefits of propoxyphene for pain relief at recommended doses outweighed the safety risks of the drug.

In January 2009, the FDA held an advisory committee meeting to address the efficacy and safety of propoxyphene. After considering the data submitted with the original drug applications for propoxyphene, as well as subsequent medical literature and postmarketing safety databases, the committee voted 14 to 12 against the continued marketing of propoxyphene products. In making this recommendation, the committee noted that additional information about the drug’s cardiac effects would be relevant in weighing its risks and benefits.

In June 2009, the European Medicines Agency (EMEA) recommended that the marketing authorizations for propoxyphene be withdrawn across the European Union. A phased withdrawal of propoxyphene is underway.

In July 2009, the FDA decided to permit continued marketing, but required that a new boxed warning be added to the drug label alerting patients and health care professionals to the risk of a fatal overdose. In addition, the agency required Xanodyne to conduct a new safety study assessing unanswered questions about the effects of propoxyphene on the heart.

The agency now has reviewed the data from that study, which show that, even when taken at recommended doses, propoxyphene causes significant changes to the electrical activity of the heart. 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. The available data also indicate that the risk of adverse events for any particular patient (even patients who have taken the drug for many years) is subject to change based on small changes in the health status of the patient, such as dehydration, a change in medications, or decreased kidney function.

“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. “However, long-time users of the drug need to know that these changes to the heart’s electrical activity are not cumulative. Once patients stop taking propoxyphene, the risk will go away.”

Xanodyne is based in Newport, Ky.



Verdicts & Settlements

Scott has been involved in numerous and diverse settlements and verdicts throughout his 18 year legal career.  He prides himself on taking care of the injured people he represents.  Scott has represented individuals from almost every state in the country and can point to settlements involving millions of dollars. Whether it be a faulty medical device, a flawed manufacturing process, a failed prescription drug or some other issue that has caused personal injury, Scott has the experience, determination and the integrity to represent a client’s interests aggressively and see that justice is served. The following examples are but a few of recent notable accomplishments:

  • Hundreds of Scott’s clients from numerous states received monetary awards in the Silicone breast implant litigation. These cases involved defective leaking or ruptured silicone implants which caused significant injury, illness and/or damage to women who relied on the manufactures of the implants.  Scott worked with the women all the way through to verdict or settlement and was responsible for ultimately settling client cases for millions of dollars.

  • Scott represented clients in the Rezulin litigation which involved a drug used by diabetics. The FDA ultimately removed the drug from the market due to liver and cardiac adverse events. Scott was involved in hundreds of hours of document review and depositions in the U.S. and Europe.  He deposed corporate witnesses who designed, manufactured, marketed and sold the drug and his clients received exceptional settlements.

  • Scott and his partner Ed Blizzard were involved in representing hundreds of individuals who suffered as a result of defective Sulzer hip and knee implant replacement joints.  Scott and Ed worked at both the state and federal level and were instrumental in developing documents and deposing corporate witnesses so that ultimately a global settlement of all claims was announced.  Scott and Ed were able to secure millions in settlement for their clients.

  • Scott represented many clients who encountered problems as a result of the diet drugs Pondimin and Redux.  He was involved with discovery committees, reviewed thousands of documents and deposed many corporate witnesses.  He tried many of these cases to verdict receiving large settlements for his clients. In December 2000, Scott tried a case in Philadelphia for two ladies from Utah who developed heart valve damage after taking the diet drug combination known as Fen-Phen. After a two week trial the jury awarded each of his clients $100 million dollars. This $200 million dollar verdict stands today as the largest Fen-Phen valvular heart disease verdict in the country. Because of this verdict, Scott was inducted into the Million Dollar and the Multi-Million Dollar Advocates Forum.

  • Scott’s clients in the Ephedra litigation were compensated well for the damages they suffered.  These cases involved  products such as Herbalife, Dexatrim, Stacker and Hydroxicut that were associated with heart attacks and strokes. He was heavily involved in developing justification documents and taking corporate depositions that ultimately led to large dollar settlements for his clients.  

Most recently, Scott began working on Paxil birth defect cases. Paxil is an antidepressant still used by millions of Americans daily.  In recent years, however, it has been associated with significant heart defects when ingested by women during the first trimester of a pregnancy.  Scott has been actively prosecuting these cases against GSK, maker of the drug. One of his cases was the first to be set for trial.  The case was resolved in favor of Scott’s client.

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Blizzard, McCarthy & Nabers, LLP represents clients in mass tort and primary pulmonary hypertension lawsuits nationwide, including Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin and Wyoming.

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