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Latest Off-label use Stories

2008-09-23 06:00:11

In a new paper published in the online open-access journal PLoS ONE, http://dx.plos.org/10.1371/journal.pone.0003150, David Pickar and colleagues of Gabriel Sciences report that 74.5% of 200 community-based schizophrenic patients, who were individually interviewed and evaluated (including a review of clinical records), were treated with off-label medication treatments. Specifically, 42.5% of subjects reported that they were simultaneously treated with more than one antipsychotic drug, an...

2008-09-17 12:00:11

To: NATIONAL EDITORS Contact: Michael Levin-Epstein, Editor-in-Chief of FDLI, +1-202- 222-0897, mdl@fdli.org WASHINGTON, Sept. 17 /PRNewswire-USNewswire/ -- More than ever, physicians in the United States are prescribing drugs, biologics and devices to treat patients in ways that were not specifically approved by FDA. This treatment often is in response to patients' increasing demand for access to drugs and devices that promise hope for treating diseases but that have not yet been...

2008-09-02 00:00:02

By The Associated Press WASHINGTON (AP) - Cody Miller was a high school football player who was allergic to ragweed. Douglas Briggs was a doctor coping with pain from an old back injury.Both are now dead, hanging victims driven to suicide, their families believe, when drugs prescribed to relieve physical symptoms upset their mental and emotional balance.Federal drug regulators are investigating to see if the families could be right.Until now, the Food and Drug Administration's attention to...

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2008-08-28 09:05:00

By Kevin Freking Associated Press What does a company do when there's anecdotal evidence that two of its drugs are equally effective in treating a leading cause of blindness in the elderly, one costing patients $60 per treatment and the other $2,000? In the case of Genentech Inc., nothing. The company declined to seek federal approval for the cheaper drug, Avastin, to treat the wet form of age-related macular degeneration. Nor would it help finance -- or cooperate with -- a National Eye...

2008-08-17 21:00:13

By BARRY MEIER By Barry Meier The New York Times Should doctors be required to undergo special education in order to prescribe powerful narcotics? The Food and Drug Administration might soon recommend that they do so, though such a move would most likely prove controversial. "I think it is a good idea, and it is something we are considering," said Dr. Bob Rappaport, the director of the division of Anesthesia, Analgesia and Rheumatology Products at the FDA. The agency itself does not...

2008-07-31 06:00:23

A report from the Government Accountability Office has blamed the FDA for the increase in 'off-label' prescribing, according to the Associated Press. According to the report, there is an inordinate delay in taking action on companies which practice off-label prescribing. While the federal agencies take approximately seven months to issue a warning to drug company peddling prescription medications, it takes another four months for the company to fix the problem. Although drug companies...

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2008-07-28 11:05:00

A report recently issued by the Government Accountability Office is shedding light onto a gray area of medical practice and federal oversight: the use of medications to treat conditions other than the ones the drugs were approved for, a practice known as "off-label" prescribing. When federal regulators discover a drug company that is selling prescription medications for unapproved use, it can take them an average of seven months to issue a warning, according to the new report. During that...

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2008-01-22 13:00:00

A British study released this week shows a dearth of new pharmaceutical medications for pregnant women, with only three new drug patents produced over the last 28 years. Among the few new treatments currently under development, many are merely improvements to existing treatments.The study was performed by Imperial College London's Nick Fisk, Professor of Fetal Medicine, and Rifat Atun, Professor of International Health Management. It is published in the journal Public Library of Science...

2007-04-14 03:00:10

By Novak, Emily; Allen, Patricia Jackson Prescribing medications "off-label" is a common practice in pediatric health care since many medications lack U.S. Food and Drug Administration (FDA) approval for pediatric drug labeling due to insufficient drug testing in children. This clinical paper reviews the FDA laws regarding approval of medications in children and the pharmacokinetic differences in absorption, distribution, metabolism and excretion between children and adults. Two commonly...

2007-03-28 18:00:36

With the U.S. Justice Department issuing three subpoenas to Johnson & Johnson this month and the The House Committee on Oversight and Government Reform requesting marketing documents from two stent and three drug manufacturers, it is clear that the ongoing investigations over drug company promotion of off-label prescriptions are heating up. Off-label prescriptions -- the practice of prescribing pharmaceutical drugs for a medical condition outside the scope of the drug's FDA-approved...


Word of the Day
omadhaun
  • A fool; a simpleton: a term of abuse common in Ireland and to a less extent in the Gaelic-speaking parts of Scotland.
This word is partly Irish in origin.