Darvon and Darvocet Recall Info

By John Gever, Senior Editor, MedPage Today
Published: November 27, 2010

When drugs that have been on the market for decades are suddenly yanked, howls of protest are often heard. But in the case of Darvon and other propoxyphene products, ordered off the market by the FDA last week, the response has been surprisingly muted.

Judging from blog posts and reader comments appended to online news stories about the withdrawal, patients had divided opinions.

Some complained that the drug had worked for them when nothing else would. Several comments on the report posted at MedPage Today partner ABCNews.com sounded positively desperate.

"This just makes me sick. I am disabled and have pain 24/7 and now don't know what I'll do," according to one.

But many others worried that they drug had hurt them. "I remember waking up from sleep in 1974 after taking prescription Darvon. It's hard to describe now after all these years, but I do remember it was frightening. I never took it again," a reader identified as "newcountryman" wrote.

According to the FDA, propoxyphene -- on the U.S. market as Darvon since 1957 and in combination with acetaminophen as Darvocet for nearly as long -- can cause cardiac arrhythmias even at recommended doses. The finding came to light in the course of a post-marketing study the agency had ordered the branded drug's maker to conduct.

Arrhythmias had previously been seen with the drug, but the FDA had believed they resulted primarily from doses somewhat over the recommended maximum.
Physicians contacted by MedPage Today and ABC News indicated almost unanimously that they seldom if ever gave patients propoxyphene products.
"I can't remember the last time, if ever, I started a patient on these medications," said Doris Cope, MD, a pain specialist at the University of Pittsburgh, in an e-mail.
She said she had occasionally maintained patients on propoxyphene who came to her clinic with an existing prescription "when they told us 'this is all that works,'" she added. "But I think we have safer, cleaner profile medications now."
Scott Boden, MD, director of Emory University's Orthopaedics and Spine Centers in Atlanta, said he preferred oxycodone- or hydrocodone-based drugs for his patients' postoperative pain.

"[The Darvon withdrawal] won't have a big impact for me," he said in an e-mail.
A family medicine specialist at the Mayo Clinic in Rochester, Minn., agreed. "It is a good example of a drug with no clear advantage over other medications intended for the same indication but with increased risks. I don't think that it will be missed," said Gregory J. Anderson, MD.

For many physicians, side effects weren't the main issue.

"In all honesty, I was not aware of the problems -- only considered Darvon a poor medication for pain control and had potential for abuse," confessed Caryl Heaton, DO, a family medicine professor at the University of Medicine and Dentistry of New Jersey in Newark, in an e-mail. "So I didn't use it."

Thomas Schwenk, MD, chairman of family medicine at the University of Michigan in Ann Arbor, commented that analgesics generally are "overused and inappropriately used."

"Physicians and patients would be better served if they made a greater distinction between acute and chronic pain, treated the former aggressively with simple analgesics including narcotics, then transitioned to chronic pain with a different therapeutic approach," he wrote in an e-mail.

This article was developed in collaboration with ABC News.

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.

FDA NEWS RELEASE

For Immediate Release: July 7, 2009
Media Inquiries: Karen Riley, 301-796-4674; karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Takes Actions on Darvon, Other Pain Medications Containing Propoxyphene

The U.S. Food and Drug Administration is taking several actions to reduce the risk of overdose in patients using pain medications such as Darvon and Darvocet that contain propoxyphene. The actions were taken because of data linking propoxyphene and fatal overdoses.

The agency is requiring manufacturers of propoxyphene-containing products to strengthen the label, including the boxed warning, emphasizing the potential for overdose when using these products. These manufacturers will also be required to provide a medication guide to patients stressing the importance of using the drugs as directed.

In addition, the FDA is requiring a new safety study assessing unanswered questions about the effects of propoxyphene on the heart at higher than recommended doses. Findings from this study, as well as other data, could lead to additional regulatory action.

“Physicians need to be aware of the risk of overdose when prescribing these drugs. They should carefully review patient histories and make appropriate treatment decisions based on the warnings and directions stated within the drug’s label,” said Janet Woodcock, M.D, director of the FDA’s Center for Drug Evaluation and Research. “Prescribers and patients should be aware of propoxyphene’s potential risks when used at doses higher than those recommended. Therefore, the FDA is requiring manufacturers to provide more information to help physicians and patients decide whether propoxyphene is the appropriate pain therapy.”

To further evaluate the safety of propoxyphene, the FDA plans to work with several groups including the Centers for Medicare & Medicaid Services and the Veterans Health Administration to study how often the elderly are prescribed propoxyphene instead of other pain relievers and the difference in the safety profiles of propoxyphene compared to other drugs.

Propoxyphene manufacturers are required to submit the requested safety labeling changes to the FDA within 30 days, or to provide a reason why they do not believe such changes are necessary. If they do not submit new language, or if the FDA disagrees with the language the companies propose, the Food, Drug, and Cosmetic Act provides strict timelines for discussions regarding the changes.  At the end of these discussions, the FDA may issue an order directing the labeling changes as deemed appropriate to address the new safety information.

Also today, the FDA denied a citizen petition from the public interest group Public Citizen requesting a phased withdrawal of propoxyphene. The agency said in its response that despite the FDA’s serious concerns about propoxyphene, the benefits of using the medication for pain relief at recommended doses outweighs the safety risks at this time.  The FDA also noted that it plans to further evaluate the safety of propoxyphene and will take additional regulatory action if necessary.

Propoxyphene has been on the market since 1957. It is a widely prescribed member of a group of drugs known as opioids and is used as a treatment for mild to moderate pain.

The most frequent side effects of propoxyphene include lightheadedness, dizziness, sedation, nausea, and vomiting.

 


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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:

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