InjuryBoard Philadelphia Archives

• New Liver Failure Warning For Antibiotic

  Jamie Sheller | June 30, 2006 1:55 PM | 0 Comments
  Category: FDA & Prescription Drugs

  The FDA has approved new safety warnings for the label of the antibiotic Ketek (telithromycin). There have been several reports of serious liver injury and liver failure associated with Ketek. The FDA advises Ketek users and their doctors to watch for signs of liver problems, which include dark-colored urine, fatigue, yellow skin and malaise. However, "the agency has concluded that the...

• Safety Alert Issued For More Boston Scientific Heart Devices

  Jamie Sheller | June 27, 2006 8:27 AM | 0 Comments
  Category: Medical Malpractice

  Boston Scientific has announced a safety alert regarding some of its pacemakers and cardiac defibrillators. "The specific subset of devices includes INSIGNIA and NEXUS pacemakers, CONTAK RENEWAL TR/TR2 cardiac resynchronization pacemakers, and VENTAK PRIZM 2, VITALITY, AND VITALITY 2 implantable cardioverter defibrillators." An identified issue with a low-voltage capacitor may cause loss of...

• Triaminic Vapor Patch Recalled

  Jamie Sheller | June 22, 2006 10:30 AM | 0 Comments
  Category: FDA & Prescription Drugs

  Novartis Consumer Health is voluntarily recalling the Triaminic Vapor Patch, due to the risk of serious harm caused by accidental ingestion. The patch is marketed as a cough suppressant, for use in children at least two years old. According to the label, the patch should be applied to the child's throat or chest. However, such a location provides the opportunity for a child to remove and chew...

• Recall of External Defibrillator

  Jamie Sheller | June 19, 2006 9:46 AM | 0 Comments
  Category: Medical Malpractice

  MRL, a division of Welch Allyn, is recalling about 500 of its model AED20 automatic external defibrillators. A faulty electrical connection could cause the device to malfunction and fail to resuscitate patients. For all customers of the recalled defibrillators, MRL will pay the costs to ship and replace the defective component. The FDA has determined that this action is a Class I recall,...

• Doctors' Group Wants Waiting Period For New Drug Advertising

  Jamie Sheller | June 15, 2006 9:23 AM | 0 Comments
  Category: FDA & Prescription Drugs

  The American Medical Association is seeking a measure requiring a waiting period before new prescription drugs or implantable devices are advertised. Last year, the drug industry adopted guidelines to delay consumer ad campaigns until after a drug company had educated doctors about its new drugs or devices. However, those guidelines are voluntary. At its annual meeting, the AMA adopted a...

• Increased Risk of Birth Defects Linked to Blood Pressure Drugs

  Jamie Sheller | June 09, 2006 8:06 AM | 0 Comments
  Category: FDA & Prescription Drugs

  Results of a recent study link the use of ACE inhibitors in the first trimester of pregnancy to an increased risk of heart and brain birth defects in babies. The FDA provided some funding for the study, which is discussed in the New England Journal of Medicine. ACE inhibitors are a certain type of drug used to treat high blood pressure. The labels of ACE inhibitors contain an FDA "black...

• Return Of Multiple Sclerosis Drug Tysabri To The Market

  Jamie Sheller | June 06, 2006 1:21 PM | 0 Comments
  Category: FDA & Prescription Drugs

  The multiple sclerosis drug Tysabri will return to the market, with limitations, over one year after it was withdrawn following the development of a rare viral brain disease in two patients from the drug's clinical trials. Tysabri was approved for marketing in November 2004 by the FDA. However, three months later, the drug was withdrawn. Later, a third patient was discovered to have the same...