FDA & Prescription Drugs

• Researchers And The Products They Review-Too Closely Connected?

  M. Brandon Smith | August 13, 2006 7:50 PM | 0 CommentsAtlanta, GA

  Over the last year or so the connection between so called "independent" researchers and the pharmaceutical companies they review have drawn a lot of attention and criticism. The main reason for this is because of the fear of biased reports and reviews from well known researchers who receive benefits from the very manufactures of the products they are reviewing.According to MSNBC.com:Many...

• FDA Has Concerns Over Anti-Depressants

  M. Brandon Smith | August 11, 2006 12:15 AM | 0 CommentsAtlanta, GA

  The Food and Drug Administration has requested that manufactures of leading anti-depressants add warnings to their labels to address recently discovered risks in newborns and migraine sufferers. The FDA's concerns stem from a life threatening condition called serotonin syndrome, which has been linked to anti-depressants like Prozac and Zoloft. The FDA has also advised patients to consult with...

• Free Lunches Come With Hidden Costs

  M. Brandon Smith | August 10, 2006 6:25 PM | 0 CommentsAtlanta, GA

  Ever wonder why some doctors prescribe one particular brand of drug over another similar drug in the class? The answer may very well be because of incentives the drug manufacturers are providing to doctors and their offices to encourage it. In a recent article in the New York Times, drug manufactures, like Merck & Co., are providing lunches as one such incentive. According to NYTimes.com:Like...

• Second Federal Vioxx Trial: Opening Arguments

  M. Brandon Smith | August 08, 2006 10:19 PM | 0 CommentsAtlanta, GA

  Both parties involved in the second federal Vioxx trial got their first chance to tell the jury what issues they will ultimately be asked to decide in the Louisiana case. The Case involves Gerald Barnett, a 62 year old former FBI agent, who blames Merck and Co. for his Vioxx related heart attack in 2002.According to Cbsnews.com:Robinson said that, during his 27 years as an FBI agent, "Jerry...

• Ketek Linked To Liver Failure

  M. Brandon Smith | August 07, 2006 8:29 PM | 0 CommentsAtlanta, GA

  The FDA is now warning of new dangers associated with Ketek, the first antibiotic of the ketolide class. Primarily used in treatment for chronic bronchitis, acute bacterial sinusitis and varying levels types of pneumonia, Ketek has been linked to rare cases of serious liver injury and liver failure. At least four confirmed deaths have been linked to the drug. To address these issues, the...

• FDA Approval Preempts Inadequate Warning Claims

  M. Brandon Smith | August 07, 2006 3:47 PM | 0 CommentsAtlanta, GA

  In an ongoing battle between the FDA and those who desire to hold pharmaceutical companies accountable for their inadequate warnings, two fairly recent cases have been decided declaring FDA approval a preemptive measure against inadequate warning claims. According to the decisions in Abramowitz v. Cephalon Inc. (New Jersey Superior Court decided March 3, 2006) and Colacicco v. Apotex, Inc.,...

• Infants Tylenol Warning Found Defective By Jury

  M. Brandon Smith | August 07, 2006 11:45 AM | 0 CommentsAtlanta, GA

  A Philadelphia jury recently awarded $5 million to the family of a 1-year-old infant who died from acetaminophen toxicity after three days of use. The Family argued the warning labels and directions were inadequate and not clear. According to Law.com For children who fit the age-and-weight description of the Dunsons' son, the label said to call a doctor for dosage amounts, according to court...

• Blame It On The Drug: Stevens-Johnson Syndrome

  M. Brandon Smith | August 06, 2006 3:27 PM | 0 CommentsAtlanta, GA

  Chances are if you are reading this blog either you or someone you know has been adversely affected by Stevens-Johnson syndrome (SJS) or its elevated equivalent Toxic Epidermal Necrolysis (TEN). It is a often times deadly reaction, usually linked to the recent use of a sulfa containing medication, that affects far too many consumers in the U.S. and throughout the world. Anywhere from 3-15% of...

• Health Risks Linked To Over-The-Counter Erectile Drugs

  M. Brandon Smith | August 06, 2006 1:54 AM | 0 CommentsAtlanta, GA

  The Federal Drug Administration recently issued a health advisory warning against over the counter dietary supplements designed to treat erectile dysfunction. Some of the drugs specifically listed in that advisory are: Zimaxx, Libidus, Neophase, Vigor-25. Actra Rx, and 4Everson. The problem associated with these supplements are that their use, when combined with other medications that contain...

• FDA Warns Against Use Of Bismacine

  M. Brandon Smith | August 06, 2006 12:03 AM | 0 CommentsAtlanta, GA

  The FDA recently issued a warning against the use of Bismacine, also known as Chromacine, which is reportedly used to treat lime disease. The drug which is mixed by druggists and not considered a pharmaceutical, is usually proscribed and administered by doctors of alternative health or by others claiming to be medical doctors.According to the FDA:This product contains high amounts of bismuth, a...