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Latest Off-label use Stories

2011-01-10 08:54:23

(Ivanhoe Newswire) -- Top-selling drugs, known as atypical antipsychotic medications, lack evidence that they'll actually be beneficial, according to a new study. Drugs in this class may cause serious effects such as weight gain, diabetes, and heart disease, along with costing Americans billions of dollars. "Because these drugs have safety issues, physicians should prescribe them only when they are sure patients will get substantial benefits," Randall Stafford, M.D., Ph.D., associate...

2010-11-19 10:51:00

MUNICH, November 19, 2010 /PRNewswire/ -- Many of the medications used to treat children have been developed almost exclusively for adults and approved for them. This is why pediatricians have been demanding for decades that medications be tailored specifically to the needs of the child's body and adequately tested on children. A regulation from the European Commission called the Pediatric Regulation has set out to solve this problem. Clinical studies involving children should ultimately...

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2010-10-20 06:20:00

More than 17,000 healthcare providers, including doctors, have received money from several major drug companies to talk to other doctors about their products, according to reports from a joint investigation by news agencies and non-profit groups. The investigation report, released on Tuesday, found that more than 380 of the health care workers took in more than $100,000 in 2009 and 2010. The report said far more doctors are likely to have taken such payments, but the reports are based on...

2010-10-01 14:27:04

Researchers from Boston University School of Medicine (BUSM) and the VA Boston Healthcare System have conducted a study that failed to show a difference in efficacy between Bevacizumab (Avastin) and Ranibizumab (Lucentis) for the treatment of age-related macular degeneration (AMD). The study, which appears currently on-line in Eye, is believed to be the first study to describe one-year outcomes of a prospective, double-masked, randomized clinical trial directly comparing bevacizumab to...

2010-09-17 11:28:00

SHORT HILLS, N.J., Sept. 17 /PRNewswire/ -- Fresh off his victory for a whistle-blower in the Forest Pharmaceuticals, Inc. lawsuit, attorney David Stone is setting his sights on the billions of dollars of settlements he expects awarded in future legal actions involving off-labeling marketing practices. "The award of $313 million in the Forest Pharmaceuticals case is just the tip of the iceberg in comparison to the amount of off-label marketing kick-back settlements we'll see in the...

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2010-09-02 06:20:00

Allergan Inc., maker of the popular Botox anti-wrinkle treatment, said on Wednesday that it had agreed to pay $600 million to settle an investigation into whether the company had illegally marketed the drug for off-label uses. In a statement, Irvine, Calif.-based Allergan said it agreed to plead guilty to one misdemeanor charge of "misbranding" its drug for unapproved medical uses between 2000 and 2005, for which it would pay the government $375 million. The settlement follows a lengthy...

2010-08-09 04:47:00

DENVER, Aug. 9 /PRNewswire/ -- Regenerative Sciences, Inc., a Colorado medical practice that specializes in the use of a person's own stem cells to help patients avoid more invasive orthopedic surgery, announced today that the US Food and Drug Administration (FDA) is seeking to enjoin the clinic physicians from practicing medicine using patients' own stem cells. The lawsuit will allow Regenerative Sciences to question the FDA's policy that adult stem cells can be classified as drugs when...

2010-07-28 15:46:00

SILVER SPRING, Md., July 28 /PRNewswire-USNewswire/ --The U.S. Food and Drug Administration today approved Cuvposa (glycopyrrolate) Oral Solution to treat chronic severe drooling caused by neurologic disorders in children ages 3 years to 16 years. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) (Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO) Drooling is normal in infants. But a significant proportion of the developmentally disabled population experiences drooling...

2010-06-11 13:35:48

An inexpensive, but unlicensed drug to help prevent severe sight loss in older people has been shown to be safe and effective, finds a study published on bmj.com today. Bevacizumab (Avastin) is licensed as a treatment for bowel cancer, but it is widely used "off label" as a considerably cheaper alternative to the approved drug ranibizumab (Lucentis) to prevent wet age related macular degeneration (AMD) and several large trials comparing the two drugs are now underway. Although ranibizumab was...

2010-05-21 16:03:00

BOSTON, May 21 /PRNewswire-USNewswire/ -- Ortho-McNeil Pharmaceutical LLC, a subsidiary of Johnson & Johnson, pled guilty today in U.S. District Court in Boston to one count of misdemeanor violation of the Food, Drug & Cosmetic Act for illegally promoting its epilepsy drug Topamax for uses that were not approved by the FDA. The company was also sentenced at today's hearing. U.S. Attorney Carmen M. Ortiz and Tony West, Assistant Attorney General for the Civil Division of the...


Word of the Day
barratry
  • The offense of persistently instigating lawsuits, typically groundless ones.
  • An unlawful breach of duty on the part of a ship's master or crew resulting in injury to the ship's owner.
  • Sale or purchase of positions in church or state.
This word ultimately comes from the Old French word 'barater,' to cheat.
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