The European Medicines Agency (EMEA), the European equivalent to the FDA, has decided that new advice is needed to warn both doctors and patients a possible link between Pfizer's stop smoking drug Champix, marketed as Chantix in the U.S., and suicide. The decision has been made to include a warning for depression, suicidal ideation or thoughts, and the possibility of suicide. Australian...
Over the last few months the troubles for Pfizer's smoking cessation drug, Chantix, have been growing by leaps and bounds. The shooting death of Dallas musician Carter Albrecht sparked public interest here in the U.S. and in the UK and Europe their version of the same drug, marketed as Champix, was thrown into the public eye after the highly publicized suicide of well known television editor...
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...
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....
Yesterday the Massachusetts Supreme Court ruled that a doctor could be sued in the event that a patient causes injury to another due to effects from the drugs prescribed by the doctor. Yesterday's ruling involved a 75 year-old man with emphysema, high blood pressure, and lung cancer. The man was prescribed several drugs to treat his various ailments. The man apparently fell asleep at the wheel...
Today the FDA announced that the heartburn medications Prilosec and Nexium do not cause heart trouble. The agency says that after investigating a possible connection suggested by a couple of studies they are now satisfied that the extremely popular medications are not responsible for the increased risks suggested by the studies. With recent controversy surrounding other one-time blockbuster...
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...
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...
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...
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