FDA & Prescription Drugs

• Deadly Asthma Drug

  Jeremy Thurman | January 13, 2006 3:47 PM | 0 CommentsNew York City, NY

  Serevent, a widely prescribed inhaled asthma treatment, may pose a special risk to african americans.Newly released details from a safety trial that was stopped early reveal that respiratory-related deaths or life-threatening events occurred four times as often among blacks who took Serevent than among blacks who did not take the drug.The findings, first reported to the U.S. Food and Drug...

• Diabetes Drug Warning

  Jeremy Thurman | January 09, 2006 10:48 AM | 0 CommentsNew York City, NY

  A warning from U.S. regulators linking GlaxoSmithKline Plc's diabetes drug Avandia to rare cases of swelling in the back of the eye is unlikely to have a major impact on sales, analysts said on Friday.The Food and Drug Administration highlighted the problem in a notice late on Thursday after the drug maker said it had received "very rare" reports of the swelling, known as macular oedema, in...

• Diabetes Patients Report Drug Side Effects

  Jeremy Thurman | January 06, 2006 11:05 AM | 0 CommentsNew York City, NY

  TheFood and Drug Administration and manufacturer GlaxoSmithKline have stated that patients taking two widely used diabetes drugs have reported blurry vision and swelling of the legs and feet. Thursday. The company said it has received "very rare" reports of new or worsening diabetic macular edema in diabetic patients who have taken Avandia or Avandamet. The swelling of the portion of the retina...

• Ortho Evra and Blood Clots

  Jeremy Thurman | January 05, 2006 10:28 AM | 0 CommentsNew York City, NY

  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,...

• Medical Journals Reliance on Drug Companies

  Jeremy Thurman | January 03, 2006 11:52 AM | 0 CommentsNew York City, NY

  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...

• FDA Advising of Risk of Birth Defects with Paxil

  Denise A. Rubin | December 30, 2005 12:42 PM | 0 CommentsNew York City, NY

  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...

• Pre-Colonoscopy Bowel Preparations Said to Cause Kidney Damage

  Denise A. Rubin | December 27, 2005 1:46 PM | 0 CommentsNew York City, NY

  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...

• Merck Opposes Judge's Vioxx Lawsuit Plans

  Jeremy Thurman | December 22, 2005 10:45 AM | 0 CommentsNew York City, NY

  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...

• Popular heartburn drugs linked to greater C. diff risk

  Jeremy Thurman | December 21, 2005 12:05 PM | 0 CommentsNew York City, NY

  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....

• Senate Voting on Bill to Bar Civil Liability For Defective Vaccines

  Denise A. Rubin | December 20, 2005 1:58 PM | 0 CommentsNew York City, NY

  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...