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Last updated on April 19, 2014 at 7:50 EDT

Latest Off-label use Stories

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...

2007-01-26 09:00:44

Salix Pharmaceuticals' antibiotic Xifaxan was approved by the FDA for the treatment of traveler's diarrhea (TD) in 2004. However, the majority of Xifaxan use is accounted for by off-label indications, growth in which is essential to its revenue potential. Taking this into account, Datamonitor forecasts sales of $106 million in 2008, ahead of Wall Street expectations of $76 million in 2008. Xifaxan is an orally administered rifamycin antibacterial that is poorly absorbed by the...

2006-06-01 05:35:32

BRUSSELS (Reuters) - Medicine made specifically for children will become more widely available in the European Union from next year following the adoption of new rules by the European Parliament on Thursday. More than half the medicines currently used to treat children have only been tested on adults and are not authorized for use specifically on infants, making it difficult for doctors to estimate the right dosage or predict side-effects. Many cancer drugs, such as carboplatin, are...

2006-03-28 11:00:00

CHICAGO -- Several labor unions are suing Pfizer Inc. for allegedly marketing its Lipitor cholesterol drug outside approved uses, resulting in the unions making billions of dollars in overpayments for members' prescriptions. The Welfare Fund of Teamsters Local Union 863 filed its proposed class action suit in U.S. District Court for the District of New Jersey late on Monday. Several other employee health care funds in other states are expected to file similar suits on Tuesday, according to...

2005-11-02 15:15:01

WASHINGTON (Reuters) - Drug makers must begin submitting electronic versions of their drug labels to build a database that doctors and patients can search for recent warnings or other changes, the U.S. Food and Drug Administration said on Wednesday. The labels will be available on the Internet within one business day of any FDA-approved change at http://dailymed.nlm.nih.gov , FDA officials said in a statement. "With this information, physicians will be able to quickly search and...

2005-08-01 16:18:35

Providence, RI - Pediatric polypharmacy, the practice of prescribing two or more medications for psychiatric symptoms in children, is on the rise in the United States, raising concern about unknown side effects, according to a new study appearing in the August issue of the journal Psychiatry 2005. "This is a critical issue - it's not uncommon to find a child on an anti-depressant, a mood stabilizer, and a sleep agent all at the same time, but there's no research to see how these drugs...