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Clinical Briefs

by U.S. Medicine

January 22, 2011

Darvon and Darvocet Removed from US 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 US market at FDA’s request. 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.

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.

FDA is advising healthcare professionals to stop prescribing propoxyphene to their patients, and patients who are currently taking the drug should contact their healthcare 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 FDA in 1957, propoxyphene is sold by prescription under various names both alone (eg, Darvon) or in combination with acetaminophen (eg, Darvocet).

Since 1978, 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In June 2009, the European Medicines Agency (EMEA) recommended that the marketing authorizations for propoxyphene be withdrawn across the European Union.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, FDA decided to permit continued marketing, but required that a new boxed warning be added to the drug label alerting patients and healthcare 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.

An FDA review of data from that study showed 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, MD, 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.”

VA Using Private Contractor to Retrieve Patient Files Quicker

VA is working on several innovations designed to significantly reduce the average time needed to obtain healthcare records from private physicians, including hiring a private contractor to retrieve patient files. When private medical records support a veteran’s application for benefits, a contractor will quickly retrieve the records from the healthcare provider, scan them into a digital format and send the material to VA through a secure transmission.

This pilot project hopes to validate initial estimates that a specialized contract can yield records required to process veterans’ disability compensation claims in seven to 10 days instead of VA’s average 40 days. In addition, the contract frees VA staff to focus on core duties to process claims more quickly.

Exploring economical contract support for time savings is one of more than three dozen initiatives supporting VA’s claims transformation plan, which aims to ensure that by 2015, veterans’ claims are decided within 125 days.

VA officials emphasize that in all cases veterans must sign documents approving the release of their medical records to the department from private healthcare providers.

The test is expected to involve about 60,000 records requests among regional benefits offices in Phoenix, New York City, St Louis, Portland,OR, Chicago, Indianapolis, and Jackson, MS. At the conclusion of the test, VA officials will decide whether to cancel, modify, or expand any changes in procedures nationwide.

Survey Puts Drunk Driving Rates Above 20% in Some States

A new survey by SAMHSA indicates that on average 13.2% of all persons 16 or older drove under the influence of alcohol and 4.3% of this age group drove under the influence of illicit drugs in the past year.

The survey’s state-by-state breakdown of drunk and drugged driving levels shows significant differences among the states. Some of the states with the highest levels of past year drunk driving were Wisconsin (23.7%) and North Dakota (22.4%). The highest rates of past year drugged driving were found in Rhode Island (7.8%) and Vermont (6.6%).

States with the lowest rates of
past year drunk driving included Utah (7.4%) and Mississippi (8.7%). Iowa and New Jersey had the lowest levels of past year drugged driving (2.9% and 3.2% respectively).

Levels of self-reported drunk and drugged driving differed dramatically among age groups. Younger drivers aged 16 to 25 had a much higher rate of drunk driving than those aged 26 or older (19.5% versus 11.8%). Similarly, people aged 16 to 25 had a much higher rate of driving under the influence of illicit drugs than those ages 26 or older (11.4% versus 2.8%).

The one bright spot in the survey is that there has been a reduction in the rate of drunk and drugged driving in the past few years. Survey data from 2002 through 2005 combined when compared to data gathered from 2006 to 2009 combined indicate that the average yearly rate of drunk driving has declined from 14.6% to 13.2%, while the average yearly rate of drugged driving has decreased from 4.8% to 4.3%. Twelve states have seen reductions in the levels of drunk driving and seven states have experienced lower levels of drugged driving. However, according to the National Highway Traffic Safety Administration’s Fatal Accident Reporting System census, one in three motor vehicle fatalities (33%) with known drug test results tested positive for drugs in 2009.

State Estimates of Drunk and Drugged Driving is based on the combined data from the 2002 to 2005 and 2006 to 2009 National Surveys on Drug Use and Health (NSDUH) and involves responses from more than 423,000 respondents aged 16 or over. NSDUH is a primary source of information on national and state-level use of tobacco, alcohol, illicit drugs (including non-medical use of prescription drugs), and mental health in the United States.

Teen Marijuana Use On Rise

Fueled by increases in marijuana use, the rate of eighth graders saying they have used an illicit drug in the past year jumped to 16%, up from last year’s 14%, with daily marijuana use up in all grades surveyed, according to the 2010 Monitoring the Future Survey (MTF).

For twelfth graders, declines in cigarette use accompanied by recent increases in marijuana use have put marijuana ahead of cigarette smoking by some measures. In 2010, 21.4% of high school seniors used marijuana in the past 30 days, while 19.2% smoked cigarettes.

The survey also shows significant increases in use of Ecstasy. In addition, nonmedical use of prescription drugs remains high. MTF is an annual series of classroom surveys of eighth, tenth, and twelfth graders conducted by researchers at the University of Michigan, Ann Arbor.

Most measures of marijuana use
increased among eighth graders, and daily marijuana use increased significantly among all three grades. The 2010 use rates were 6.1% of high school seniors, 3.3% of tenth graders, and 1.2% of eighth graders compared to 2009 rates of 5.2%, 2.8%, and 1.0%, respectively.

The MTF survey also showed a significant increase in the reported use of MDMA, or Ecstasy, with 2.4% of eighth graders citing past-year use, compared to 1.3% in 2009. Similarly, past-year MDMA use among tenth graders increased from 3.7% to 4.7% in 2010.

Also of concern is that the downward trend in cigarette smoking has stalled in all three grades after several years of marked improvement on most measures. Greater marketing of other forms of tobacco prompted the 2010 survey to add measures for 12th graders’ use of small cigars (23.1%) and of tobacco with a smoking pipe known as a hookah (17.1%).

Prescription drug abuse remains a serious concern. Although Vicodin® abuse decreased in 12th graders this year to 8%, down from around 9.7% the past four years, other indicators confirm that nonmedical use of prescription drugs remains high. For example, the use of OxyContin®, another prescription opiate, stayed about the same for 12th graders at 5.1% in 2010. Six of the top 10 illicit drugs abused by 12th graders in the year prior to the survey were prescribed or purchased over the counter. The survey again found that teens generally get these prescription drugs from friends and family, whether given, bought, or stolen.

However, the survey says binge drinking continued its downward trend. Among high school seniors, 23.2% report having five or more drinks in a row during the past two weeks, down from 25.2% in 2009 and from the peak of 31.5% in 1998. In addition, 2010 findings showed a drop in high school seniors’ past-year consumption of flavored alcoholic beverages, to 47.9% in 2010 from 53.4% in 2009. Past-year use of flavored alcohol by eighth graders was at 21.9 percent, down from 27.9% in 2005.

The MTF survey also measures teen attitudes about drugs, including perceived harmfulness, perceived availability, and disapproval, all of which can predict future abuse. Related to its increased use, the perception that regular marijuana smoking is harmful decreased for 10th and 12th graders. Disapproval of smoking marijuana decreased significantly among eighth graders.

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