FDA & Prescription Drugs

• FDA Labeling Change And Child Suicide Increase-Is There A Link?

  M. Brandon Smith | March 08, 2007 8:38 PM | 0 CommentsAtlanta, GA

  The mandate of a black box warning by the U.S. Food and Drug Administration concerning many antidepressant medications over the last few years has sparked a debate among many scholars as to whether the mandate has caused an increase in teenage suicide. The warning, which informed doctors of a potential risk of increased suicidal thoughts among its users, was ordered by the FDA in 2004 on...

• Big Pharma Wins Again-FDA Drops Plan To Warn Consumers Of Potentially Dangerous Drugs

  M. Brandon Smith | March 06, 2007 9:23 PM | 0 CommentsAtlanta, GA

  The U.S. Food and Drug Administration announced last Friday that it no longer intends to publish a public list of potentially dangerous prescription drugs that was going to warn the consuming public of potential safety concerns and risks. The idea was discussed and proposed by the FDA after the withdrawal of Merck & Co.'s arthritis drug Vioxx in 2004. Instead now the FDA has decided it will only...

• Arcoxia, A Vioxx Substitute, Is Being Considered By The FDA For Approval

  M. Brandon Smith | March 04, 2007 2:53 PM | 0 CommentsAtlanta, GA

  The U.S. Food and Drug Administration panel has set out to review Arcoxia, Merck & Co. Inc.'s replacement pain reliever drug for Vioxx which was recalled back in 2004. In a meeting set for April 12, 2007, the panel expects to discuss the safety and effectiveness of Arcoxia which is being heavily pushed by Merck for FDA approval. Of note worthy concern, Arcoxia, like Vioxx and Bextra, is a cox-2...

• Plaintiff Verdict On Liability In New Jersey Vioxx Trial

  M. Brandon Smith | March 04, 2007 6:34 AM | 0 CommentsAtlanta, GA

  In the latest New Jersey Vioxx trial, the jurors rendered a verdict in favor of the plaintiff, Frederick "Mike" Humeston, who took Vioxx prior to his death. In this bifurcated preceding designed only to address Merck's potential liability, the New Jersey state court jury found that Merck & Company failed to warn about the dangers associated with Vioxx in causing cardiovascular risks and...

• Jury Selection Begins In Latest Vioxx Trial

  M. Brandon Smith | February 28, 2007 10:17 PM | 0 CommentsAtlanta, GA

  Jury selection for the latest Vioxx trial is under way for a man whose wife is said to have died as a result of taking Vioxx. Frank Schwaller says his wife, then 52 and now deceased, took the painkiller manufactured by Merck & Company for an extended period to combat her pains and ailments. The attorney for Schwaller asked the prospective juror members a number of questions to determine if they...

• $3 Million Verdict In Prempro Lawsuit-Wyeth Held Liable

  M. Brandon Smith | February 20, 2007 6:17 PM | 1 CommentAtlanta, GA

  Prempro lawsuit leads to a $3 million verdict against its manufacturer Wyeth after causing an Ohio woman's breast cancer. The Philadelphia Court of Common Pleas jury found that Wyeth ``failed to provide an adequate warning'' to the plaintiff given the known side effects of it use. This was the fifth trial against Wyeth and marks the largest jury verdict thus far. Three of the other trials...

• Trasylol Lawsuit Filed-Many More Expected Due To Kideny Problems

  M. Brandon Smith | February 20, 2007 5:35 PM | 0 CommentsAtlanta, GA

  On January 25, 2007 a products liability lawsuit was filed on behalf of Mrs. Ada M. Williams against Bayer Corporation and Bayer AG after receiving their drug Trasylol during her open-heart surgery. According to the Trasylol lawsuit, Ms. Williams subsequently went into kidney failure and now has to undergo kidney dialysis three times a week due to complications caused by the drug. Ms. Williams'...

• Stonger Warnings Demanded For Trasylol (Open Heart Surgery Medication)

  M. Brandon Smith | January 06, 2007 12:02 PM | 0 CommentsAtlanta, GA

  The Food and Drug Administration has said that the manufacturer of Trasylol (aprotinin) needs to use a stronger warning associated with the drug to address the overwhelming number of risks associated with kidney damage. Bayer is being asked by the FDA to promote the use of Trasylol, a drug which is used to help reduce blood loss during coronary artery bypass surgeries, only in patients who are...

• More Warnings Against Pregnant Women Taking Paxil

  M. Brandon Smith | December 02, 2006 10:29 PM | 0 CommentsAtlanta, GA

  In a recent opinion from the American College of Obstetricians and Gynecologists, pregnant women are being told to not take the antidepressant Paxil because of the increased risk of birth defects in a fetus. This group's view comports with the same findings the FDA noted earlier this year when two other studies showed that Paxil almost doubled the chance of developing heart defects in infants...

• Trasylol Is A Dangerous Drug

  M. Brandon Smith | October 22, 2006 9:56 AM | 0 CommentsAtlanta, GA

  Trasylol (aprotinin), manufactured by Bayer, is a medication used to treat excessive bleeding and inflammation in patients undergoing coronary artery bypass grafting surgery (CABG). Due to nature of CABG procedures, most people do not realize they received the drug until after the surgery is over, if ever. That practice however is slowly changing as the FDA and the New England Journal of...