FDA & Prescription Drugs

• Life-Threatening Events Associated with Tussionex

  Scott Kappes | March 11, 2008 8:20 PM | 0 CommentsGalveston Bay, TX

  Today the FDA informed health care professionals of life-threatening adverse events and death in patients taking Tussionex Pennkinetic Extended Release Suspension. According to the FDA website doctors have prescribed the hydrocodone containing cough suppressant to children under the recommended age of six. Additional reports of physicians prescribing the medication at more frequent intervals...

• Black Box Warning Added to Anemia Drugs

  Scott Kappes | March 11, 2008 1:19 PM | 0 CommentsGalveston Bay, TX

  Last Friday the FDA added the strictest warning available to three anemia medications. The black box warning warns of an increased risk of death and tumor growth associated with the medications. Amgen's Aranesp and Epogen and Johnson & Johnson's Procrit have been shown to accelerate tumor growth in patients with several different types of cancer. The drugs had been linked to similar risks in...

• Jury Awards $27 Million in Hormone Lawsuit

  Scott Kappes | March 10, 2008 10:33 AM | 0 CommentsGalveston Bay, TX

  Last Thursday a jury ordered Wyeth Pharmaceuticals and Upjohn to shell out over $27 million in compensation to an Arkansas woman who developed breast cancer after taking hormone replacement therapy. The jury ruled in favor of Donna Scroggin citing that the companies failed to provide adequate warnings of the drugs Premarin and Prempro. The jury decided that Scroggin should receive $19.3 million...

• Mother Files Lawsuit Over Birth Defects

  Scott Kappes | March 06, 2008 1:01 PM | 0 CommentsGalveston Bay, TX

  In September of 2005 Faith Gibson of Canada gave birth to Meah, a beautiful baby girl. Meah was born with a hole in her heart, which required surgery and a seven-month hospital stay. Faith believed at the time that her daughter's condition was just an unfortunate happenstance, but last year after reading an article about birth defects associated with the prescription antidepressant Paxil she...

• Anemia Drugs Cited For Death Risks

  Scott Kappes | February 26, 2008 7:36 PM | 0 CommentsGalveston Bay, TX

  Today an article published in the Journal of the American Medical Association claims that commonly used anemia drugs sold by Amgen and Johnson & Johnson raise the risk of death in cancer patients by about 10 percent. The publication, based on new analysis of existing clinical trial data, comes just as the FDA is planning to convene an advisory panel to address concerns associated with the...

• Trasylol Linked to Death and Kidney Problems Following Surgery

  Scott Kappes | February 26, 2008 11:34 AM | 0 CommentsGalveston Bay, TX

  Two studies published in the New England Journal of Medicine have linked the drug Trasylol, used to reduce bleeding during open-heart surgery, to an increased risk of death and kidney damage among other concerns. Patients taking Trasylol were found to be 27 percent more likely to die a decade after surgery than those who received a rival drug in a study of over 10,000 patients. Another study of...

• Chantix to be Tested for Anti-Addiction Possibilities

  Scott Kappes | February 20, 2008 9:42 AM | 0 CommentsGalveston Bay, TX

  A report published today claims that clinical trials will begin next month to see if Pfizer's stop smoking drug, Chantix, can be an effective treatment for curbing drinking and gambling habits. The drug has been shown to be effective in treating smoking addiction, but has been met with widespread controversy over a possible link to neuropsychiatric events, including suicidal ideation and...

• Big Pharma May Soon Be Allowed to Promote Off-Label Uses

  Scott Kappes | February 19, 2008 1:08 PM | 0 CommentsGalveston Bay, TX

  The FDA recently released a draft of guidelines that would allow drugmakers to distribute reprints of peer-reviewed journal articles that suggest off-label uses for their medications. Doctors have always been able to prescribe drugs as they see fit and off-label prescription is commonplace throughout the medical field, but drugmakers have never been allowed to promote medications for any use...

• Additional Fentanyl Patches Recalled

  Scott Kappes | February 18, 2008 6:27 PM | 0 CommentsGalveston Bay, TX

  Today Actavis South Atlantic LLC announced the recall of several lots of fentanyl pain patches. This is the second recall of fentanyl pain patches in one week's time. Last week Johnson & Johnson issued a recall of specific lots of 25 microgram per hour Duragesic pain patches, for a risk that the some patches may have a defect that allows the medication to be releases faster than intended,...

• FDA Accuses Sanofi of Fraud in Ketek Trials

  Scott Kappes | February 18, 2008 12:25 PM | 0 CommentsGalveston Bay, TX

  A former clinical research associate who worked on the clinical trials for the antibiotic, Ketek, said that researchers and Sanofi-Aventis worked together to defraud the FDA. Ketek has been linked to liver problems and according to allegations by the FDA the manufacturer, Sanofi-Aventis, made deliberate efforts to conceal evidence that would be harmful to the drug during the post marketing...