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Latest Off-label use Stories

2009-09-16 14:56:34

The drug Instanyl helps treat breakthrough cancer pain, an Italian researcher said. The multinational crossover trial found the painkiller administered through the nose more effective than oral transmucosal fentanyl citrate in treating fast onset, intense pain breaking through chronic cancer pain being controlled with other medications. Instanyl, the first intranasal treatment for breakthrough cancer pain to be licensed, was also preferred to the other orally administered drug by 77 percent...

2009-09-02 10:35:00

Pfizer to Pay $2.3 Billion for Fraudulent Marketing WASHINGTON, Sept. 2 /PRNewswire-USNewswire/ -- American pharmaceutical giant Pfizer Inc. and its subsidiary Pharmacia & Upjohn Company Inc. (hereinafter together "Pfizer") have agreed to pay $2.3 billion, the largest health care fraud settlement in the history of the Department of Justice, to resolve criminal and civil liability arising from the illegal promotion of certain pharmaceutical products, the Justice Department announced...

2009-09-02 09:48:00

PHILADELPHIA, Sept. 2 /PRNewswire/ -- Pfizer, Inc. announced today it has agreed to plead guilty to criminal conduct and to pay more than $2 billion in criminal and civil fines, penalties and damages to settle allegations made in multiple whistleblower lawsuits that the pharmaceutical giant defrauded Medicare, Medicaid and other government-funded health care programs in connection with its market practices for four of its drugs. The settlement is the largest qui tam settlement in U.S....

2009-09-02 09:48:00

Includes Allegations of Illicitly Promoting Antibiotic As Clinically Superior When Its Own FDA-Approved Label Said Otherwise; First-Ever Qui Tam Whistleblower Settlement of Its Type PHILADELPHIA, Sept. 2 /PRNewswire-USNewswire/ -- Pfizer Inc. ignored a 2005 FDA Warning Letter to stop promoting its antibiotic Zyvox(R) as clinically superior to the significantly less expensive, generic vancomycin when its own FDA-approved label indicated otherwise. The drug giant also defrauded federal...

2009-09-02 09:37:00

WASHINGTON, Sept. 2 /PRNewswire/ -- The decision by a Pfizer sales representative in Florida to file a whistleblower ("qui tam") lawsuit in 2003 kicked off the federal and state investigations that led to Pfizer's record-breaking $2.3 billion settlement today. "In the Army, I was expected to protect people at all costs," said the whistleblower, John Kopchinski, a West Point graduate and Gulf War veteran. "At Pfizer I was expected to increase profits at all costs, even when sales meant...

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2009-09-02 10:30:00

The U.S. Department of Justice said pharmaceutical giant Pfizer will pay a record $2.3 billion fine to settle fraudulent marketing of the painkiller Bextra. Bextra was pulled off the market in 2005. The case settled Wednesday involved Pfizer's marketing of the drug for uses not approved by the Food and Drug Administration. A company must specify the intended use of a product, the Department of Health and Human Services said in a release. Once approved, the drug may not be marketed or promoted...

2009-08-27 07:35:50

A number of physicians erroneously believed that certain off-label uses of prescription drugs were approved by the Food and Drug Administration (FDA), according to a recent national survey. "Off-label use" refers to prescribing a drug for a purpose outside the scope of a drug's approved label. The FDA makes it clear that they regulate the marketing of prescription drugs, not prescribing. The agency approves drugs for marketing with an official "label" that stipulates an indication, dose,...

2009-08-24 18:11:00

Some physicians erroneously think certain off-label uses of prescription drugs are approved by the U.S. Food and Drug Administration, researchers said. Corresponding author Dr. G. Caleb Alexander of the University of Chicago Medical Center said this mistaken belief could encourage doctors to prescribe the drugs, despite the lack of scientific evidence supporting such use. The FDA approves drugs for marketing with an official label that stipulates an indication, dose, intended population,...

2009-08-21 08:31:54

Physicians lack knowledge of off-label drug use and FDA approval statusIn a recent national survey, a substantial minority of physicians erroneously believed that certain off-label uses of prescription drugs were approved by the Food and Drug Administration. This mistaken belief could encourage them to prescribe these drugs, despite the lack of scientific evidence supporting such use."Off-label prescribing is common, but researchers have not always known why. Our research shows that some...

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2009-06-25 11:20:00

Consumer advocate groups said on Wednesday that the U.S. Food and Drug Administration should make more information available to the public, even on drugs and devices that never make it to the U.S. market, Reuters reported. But findings or data containing confidential company information could harm competition if made widely available, according to industry representatives. Several advocates and former FDA staff reviewers said that while the FDA often provides public details on products that...


Word of the Day
cock-a-hoop
  • Exultant; jubilant; triumphant; on the high horse.
  • Tipsy; slightly intoxicated.
This word may come from the phrase 'to set cock on hoop,' or 'to drink festively.' Its origin otherwise is unclear. A theory, according to the Word Detective, is that it's a 'transliteration of the French phrase 'coq a huppe,' meaning a rooster displaying its crest ('huppe') in a pose of proud defiance.' Therefore, 'cock-a-hoop' would 'liken a drunken man to a boastful and aggressive rooster.'
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