Darvocet withdrawn from U.S. market after FDA link to heart problems
The U.S. Food and Drug Administration has announced that Xanodyne Pharmaceuticals, inc., the maker of prescription pain medications Darvon and Darvocet, has agreed to withdraw the medications from the U.S. market. The move comes after the results of an FDA study in which new clinical data shows the drug, which goes by the generic name propoxyphene, puts patients at risk of potentially serious or even fatal heart rhythm abnormalities. The FDA determined the new data shows the risks of the drug outweigh any benefits.
The FDA has informed the generic manufacturers of propoxyphene-containing products of Xanodyne's decision to remove its medications from the market and has requested they voluntarily remove their products as well. The FDA is advising health care professionals to stop prescribing propoxylene 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 medication 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 (Darvon) or in combination with acetaminophen (Darvocet). After safety concerns were raised in 1978, and again in 2009, the FDA formed an advisory committee to review available data. In July 2009, a boxed warning was added to the drug, alerting patients and health care professionals of the danger of overdose. At that time, the FDA also required Xanodyne to conduct a new safety study assessing unanswered questions about the effect of propoxyphene on the heart.
Results of the study show that even when taken at recommended doses, propoxyphene causes significant changes to the electrical activity of the heart. These changes can increase the risk for serious abnormal heart rhythms that have been linked to serious adverse effects, including sudden death.
DePuy Orthoaedics Hip Implant Replacment Recall
Johnson & Johnson, in conjunction with its DePuy Orthopaedics subsidiary, announced at the end of August 2010 that it is recalling parts used for hip replacements. At issue is the high rate of repeat surgeries needed by people who have received the parts.
An estimated 93,000 people will be affected by Johnson & Johnsonç—´ latest product recall. Affected hip replacement parts involved in the recall include the DePuy ASR XL Acetabular System, which is the cup portion of a replacement hip joint, and the DePuy ASR Hip Resurfacing System. Resurfacing involves implanting a cup and capping the ball at the top of the thighbone in a procedure that preserves more bone than traditional replacements. It is geared toward younger patients. Although this recall is voluntary, DePuy also received a warning letter from the FDA that charges the company is marketing some other joint replacement products without required approval.
Physicians were notified about potential problems with the hip replacement parts beginning in March of this year. The decision to recall the parts was made when the results of a new study confirmed a five-year rate of revision surgery of about 12 percent for the ASR resurfacing system and about 13 percent for the ASR XL system, according to DePuy, which is higher than the expected rate. Patients who reported problems in the first five years and had revision surgery reported a variety of symptoms, including pain, swelling and problems walking. These symptoms are normal for patients following a hip replacement, but can be a sign that something is wrong if they continue or come back frequently.
These symptoms may indicate serious problems, including:
Loosening - when the implant does not stay attached to the bone in the correct position
Fracture - where the bone around the implant may have broken
Dislocation - where the two parts of the implant that move against each other are no longer aligned
What can be done? If you or a loved one has been injured by Depuy APR hip replacement parts, you may have a claim against the manufacturers. Please contact us today by calling 1-205-752-4440 for a free, no-cost, no-obligation evaluation of your case.
What Do I Do If I Have Received a Notice About the Depuy Hip Replacement Recall?
Contact personal injury attorney Randal S. Ford about your situation. There is no charge or obligation for a review of your case.