FDA & Prescription Drugs

• Even More Evidence Mounts Against Avandia

  Scott Kappes | December 11, 2007 11:26 PM | 0 CommentsGalveston Bay, TX

  Today an article published in the Journal of the American Medical Association cites a new study out of Canada that suggests a significantly elevated risk of heart attack in patients treated by Avandia. The study was a retrospective analysis of medical records of over 159,000 patients age 65 and older. GlaxoSmithKline claims that the study is flawed and maintains that Avandia is safe. The...

• Chantix To Carry Warning For Suicidal Thoughts In Australia

  Scott Kappes | December 11, 2007 12:34 PM | 0 CommentsGalveston Bay, TX

  Over the past few months there has been plenty of attention paid to Pfizer's smoking cessation drug, Chantix. Reports of serious side effects have been pouring into the FDA's Adverse Event Reporting System. Reports of suicide and suicidal ideation have been all too common among these reports. The FDA says they are also investigating over 100 cases of psychotic behavior associated with the drug....

• Quaid Family Sues For Child Overdose

  Scott Kappes | December 07, 2007 5:20 PM | 0 CommentsGalveston Bay, TX

  Actor Dennis Quaid and his wife plan to sue Baxter Healthcare for not providing adequate labeling on their product. Quaid's twins were accidentally given 10,000 units of the blood thinner Heparin, instead of the intended 10 units. Although human error was involved the lawsuit alleges that Baxter Healthcare should be held accountable because the label s for the 10-unit vial and the 10,000-unit...

• Over 5,000 Chantix Complaints Filed in One Week

  Scott Kappes | December 05, 2007 2:02 PM | 0 CommentsGalveston Bay, TX

  It has been a couple of weeks now since the FDA launched their investigation into the safety of Pfizer's smoking cessasation drug Chantix. The FDA says that they were planning to review the drug based on reports from the UK where the same drug has been sold since 2006 under the name Champix; however, the shooting death of musician Carter Albercht served as a catalyst to put safety concerns about...

• Avastin Approval for Breast Cancer Looks Grim

  Scott Kappes | December 04, 2007 1:28 PM | 0 CommentsGalveston Bay, TX

  Yesterday the FDA released a briefing on Genentech's application to have their cancer drug Avastin be marketed and sold as a viable treatment for breast cancer. The tone of the document does not suggest that Avastin will get the approval it desires. Studies have shown that the drug is effective in slowing the progression of the disease; however, Avastin was not shown to increase the overall...

• FDA Panel Warns Of Provigil Use in Children

  Scott Kappes | November 30, 2007 5:34 PM | 0 CommentsGalveston Bay, TX

  On Wednesday the an FDA panel suggested that Cephalon's sleep disorder drug, Provigil, should care a stricter warning urging doctors not to prescribe the drug to children. The drug is approved to treat various sleep disorders in adults; however, doctors have been frequently prescribing the drug to treat the same disorders in children. The FDA is concerned that this could have serious adverse...

• Advair Gets New Warning for Use by Kids

  Scott Kappes | November 29, 2007 11:33 AM | 0 CommentsGalveston Bay, TX

  Yesterday a panel of outside experts commissioned by the FDA advised the administration that the popular asthma medications Advair and Serevent should carry an additional warning for use in children. The new warning, if accepted by the FDA, will reportedly advise of a potential increased risk of asthma related hospitalization. The panel also said the warning should be more specific for children....

• Flu Drugs Get New Warnings

  Scott Kappes | November 28, 2007 10:14 AM | 0 CommentsGalveston Bay, TX

  Yesterday the U.S. Food and Drug Administration voted to revise the labels of the popular flu medications Tamiflu and Relenza. The new warnings will inform consumers of possible psychiatric problems associated with the drugs. There have been numerous reports of delirium and hallucinations tied to the drug, the majority coming from Japan, but no causal relationship has been confirmed. The new...

• FDA Warns of Strange Behavior Associated with Flu Medications

  Scott Kappes | November 26, 2007 9:37 AM | 0 CommentsGalveston Bay, TX

  Flu medications have been under fire in other countries, particularly Japan, for years now. Patients in Japan have frequently complained of very uncharacteristic behavior while taking drugs like Roche's Tamiflu and GlaxoSmithKline's Relenza. The behaviors reported include hallucinations and other strange reactions. The FDA has recently received similar reports from patients in the United States....

• FDA Reviewing Chantix

  Scott Kappes | November 21, 2007 9:07 AM | 0 CommentsGalveston Bay, TX

  The Food and Drug Administration is currently is the process of further review of the smoking cessation drug Chantix. This review comes in response to numerous complaints of erratic behavior and suicidal ideation from users of the drug. Pfizer, the manufacturer, was hoping that Chantix could become a blockbuster drug recognized as the common treatment for smoking cessation. By looking at sales...