FDA & Prescription Drugs | InjuryBoard New York City

ORTHO EVRA birth control is a weekly birth control patch that was introduced into the market in November 2001. In 2004, ORTH EVRA accounted for more than 9.9 million prescriptions with sales topping a staggering $411 million. However, in November 2005, the FDA issued a black box warning label for the ORTHO EVRA birth control patch. Black box warnings are designed to highlight special problems,...

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Medical journals are no more than "an extension of the marketing arm of pharmaceutical companies" because a large proportion of their revenue comes from drug advertisements and reprints of company funded trials, claims former BMJ editor, Richard Smith.Dr Smith, who is now chief executive of UnitedHealth Europe has argued that the medical journals sizable incomes from drug advertising is...

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Food and Drug Administration Warns of Possible Birth Defects Tied to Mothers' Ingestion of Paxil.Agency Requiring Updated Product LabelingEarlier this month, the Food and Drug Administration alerted health care professionals and patients about early results of new studies for Paxil (paroxetine) suggesting that the drug increases the risk for birth defects, particularly heart defects, when women...

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The Columbia College of Physicians and Surgeons has recently reported 21 cases of acute kidney failure from some of the bowel-cleansing preparations some of which are sold over-the-counter for use on the night prior to colonoscopy. In an article on December 27, 2005, the New York Times reports that the Columbia College of Physicians and Surgeons has recently reported 21 cases of acute kidney...

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Merck, the maker of the drug Vioxx, has recently said it opposes a plan by a New Jersey judge to limit upcoming Vioxx lawsuit trials to those involving users who took the drug for 18 months or longer. Superior Court Judge Carol Higbee, whose court is overseeing about half of the U.S. personal-injury suits involving Vioxx, will hold a hearing Thursday on the matter. Merck has opposed the ideas...

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Watch out for heartburn as you eat away over the holidays. People on popular prescription heartburn drugs - Prilosec, Prevacid and Nexium - and some over-the-counter versions seem more prone to getting a potentially dangerous diarrhea caused by the bug Clostridium difficile, new research shows. C. diff, as it's known, can cause severe diarrhea and crampy intestinal inflammation called colitis....

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On Wednesday, December 21, 2005, the Senate will vote on the vaccine immunity amendment that was just passed by the House. This bill -- Section 6 of S. 1873, the Biodefense and Pandemic Vaccine and Drug Development Act of 2005, sponsored by Senator Richard Burr, R-N.C. -- would set a dangerous and unprecedented standard of care for drug manufacturers, allowing civil suits only when a drug...

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Diagnostic imaging agent NeutroSpec has been withdrawn from the market by order of the Food and Drug Administration. The drug has been tied to numerous adverse allergic-type responses shortly after injection, including 2 deaths.The United States Food & Drug Administration has ordered the withdrawal of NeutroSpec, a diagnostic imaging agent used for diagnosis of suspected cases of appendicitis in...

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